Trial Outcomes & Findings for A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy (NCT NCT00220337)

NCT ID: NCT00220337

Last Updated: 2023-07-24

Results Overview

Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (\<=.85x Lower Limit Normal \[LLN\] or \>= 1.15x Upper Limit Normal \[ULN\] - Hemoglobin (\<=.85x LLN or \>=1.15x ULN) - White Blood Cell (WBC) Count (\<=3.0 or \>=16.0 G/l) - Basophils (\>=5.0%) - Eosinophils (\>=10%) - Monocytes (\>=20%) - Platelet Count (\<=100 or \>=600 G/l)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 371 participants
• Primary outcome timeframe: During the maintenance period (up to 136 weeks)
• Results posted on: 2023-07-24

Participant Flow

The study started to enroll patients in December 2004 and concluded in October 2007.

Participant Flow refers to the Safety Set.

Participant milestones

Measure	Lacosamide Subjects received lacosamide 100 mg (milligrams)/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Study STARTED	371
Overall Study COMPLETED	192
Overall Study NOT COMPLETED	179

Reasons for withdrawal

Measure	Lacosamide Subjects received lacosamide 100 mg (milligrams)/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Overall Study Adverse Event	70
Overall Study Lack of Efficacy	17
Overall Study Withdrawal by Subject	68
Overall Study Protocol Violation	2
Overall Study Lost to Follow-up	5
Overall Study Other	12
Overall Study Unsatisfactory compliance	5

Baseline Characteristics

A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

Baseline characteristics by cohort

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	262 Participants n=5 Participants
Age, Categorical >=65 years	109 Participants n=5 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 9.99 • n=5 Participants
Sex: Female, Male Female	181 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Screening until Safety Follow up Visit (up to 140 weeks)

Population: The Safety Set (SS) was defined as all subjects who signed the informed consent form and took at least 1 dose of trial medication.

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator	80.9 percentage of participants

PRIMARY outcome

Timeframe: During the titration period (up to Week 8)

Population: Safety Set included 371 subjects. Only subjects with valid data for hematology parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different hematologic parameters.

Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (<=.85x Lower Limit Normal [LLN] or >= 1.15x Upper Limit Normal [ULN] - Hemoglobin (<=.85x LLN or >=1.15x ULN) - White Blood Cell (WBC) Count (<=3.0 or >=16.0 G/l) - Basophils (>=5.0%) - Eosinophils (>=10%) - Monocytes (>=20%) - Platelet Count (<=100 or >=600 G/l)

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period Hematocrit	0.8 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period Hemoglobin	0.5 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period White Blood Cell	1.4 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period Basophils	1.1 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period Eosinophils	0 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period Monocytes	0 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period Platelet Count	1.1 percentage of participants

PRIMARY outcome

Timeframe: During the maintenance period (up to 136 weeks)

Population: Safety Set included 371 subjects. Only subjects with valid data for hematology parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different hematologic parameters.

Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (<=.85x Lower Limit Normal [LLN] or >= 1.15x Upper Limit Normal [ULN] - Hemoglobin (<=.85x LLN or >=1.15x ULN) - White Blood Cell (WBC) Count (<=3.0 or >=16.0 G/l) - Basophils (>=5.0%) - Eosinophils (>=10%) - Monocytes (>=20%) - Platelet Count (<=100 or >=600 G/l)

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period Hematocrit	6.2 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period Hemoglobin	5.5 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period WBC Count	2.8 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period Basophils	2.8 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period Eosinophils	2.8 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period Monocytes	0.3 percentage of participants
Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period Platelet Count	4.4 percentage of participants

PRIMARY outcome

Timeframe: During the titration period (up to Week 8)

Population: Safety Set included 371 subjects. Only subjects with valid data for clinical chemistry parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different clinical chemistry parameters.

Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase ([ALT] 3x ULN) - Alanine aminotransferase ([ALT] 5x ULN) - Alanine aminotransferase [(ALT] 10x ULN) - Aspartate aminotransferase ([AST] 3x ULN) - Aspartate aminotransferase ([AST] 5x ULN) - Aspartate aminotransferase ([AST] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase ([GGT] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (<26 g/l) - Blood Urea Nitrogen (>=14.28 mmol/l) - Creatinine (>=2.0 mg/dl) - Calcium (<=7.6 or >=11.0 mg/dl) - Chloride (<=90 or >=112 mmol/l) - Phosphorus (<=2.0 or >=6.0 mg/dl) - Potassium (<=3.0 or >=6.0 mmol/l) - Sodium (<127 or >151 mmol/l) - Glucose (<50 or >=200 mg/dl) - Total Cholesterol (>6.5 mmol/l) - Uric Acid (>565.06 umol/l)

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period ALT 3xULN	0.5 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period ALT 5xULN	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period ALT 10xULN	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period AST 3xULN	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period AST 5xULN	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period AST 10xULN	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Alkaline Phosphatase	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period GGT 3xULN	0.6 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Total Bilirubin	0.5 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Albumin	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Blood Urea Nitrogen	0.8 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Creatinine	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Calcium	1.7 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Chloride	0.3 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Phosphorus	1.4 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Potassium	0.3 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Sodium	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Glucose	40.6 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Total Cholesterol	3.2 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period Uric Acid	1.1 percentage of participants

PRIMARY outcome

Timeframe: During the maintenance period (up to 136 weeks)

Population: Safety Set included 371 subjects. Only subjects with valid data for clinical chemistry parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different clinical chemistry parameters.

Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase ([ALT] 3x ULN) - Alanine aminotransferase ([ALT] 5x ULN) - Alanine aminotransferase [(ALT] 10x ULN) - Aspartate aminotransferase ([AST] 3x ULN) - Aspartate aminotransferase ([AST] 5x ULN) - Aspartate aminotransferase ([AST] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase ([GGT] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (<26 g/l) - Blood Urea Nitrogen (>=14.28 mmol/l) - Creatinine (>=2.0 mg/dl) - Calcium (<=7.6 or >=11.0 mg/dl) - Chloride (<=90 or >=112 mmol/l) - Phosphorus (<=2.0 or >=6.0 mg/dl) - Potassium (<=3.0 or >=6.0 mmol/l) - Sodium (<127 or >151 mmol/l) - Glucose (<50 or >=200 mg/dl) - Total Cholesterol (>6.5 mmol/l) - Uric Acid (>565.06 umol/l)

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period ALT 3xULN	0.6 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period ALT 5xULN	0.3 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period ALT 10xULN	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period AST 3xULN	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period AST 5xULN	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period AST 10xULN	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Alkaline Phosphatase	0.3 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period GGT 3xULN	4.7 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Total Bilirubin	0.3 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Albumin	0.3 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Blood Urea Nitrogen	2.1 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Creatinine	0.6 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Calcium	2.5 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Chloride	3.4 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Phosphorus	3.4 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Potassium	2.8 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Sodium	0 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Glucose	66.8 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Total Cholesterol	0.7 percentage of participants
Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period Uric Acid	1.5 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 5.0 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Outcome measures

Measure	Lacosamide n=239 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit pH= 5.0	194 Participants
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit pH= 6.0	35 Participants
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit pH= 6.5	2 Participants
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit pH= 7.0	3 Participants
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit pH= 7.5	1 Participants
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit pH= 8.0	0 Participants
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit pH= 8.5	0 Participants
Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit not done	4 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 6.0 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Outcome measures

Measure	Lacosamide n=93 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit pH= 5.0	52 Participants
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit pH= 6.0	31 Participants
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit pH= 6.5	4 Participants
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit pH= 7.0	2 Participants
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit pH= 7.5	1 Participants
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit pH= 8.0	1 Participants
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit pH= 8.5	0 Participants
Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit not done	2 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 6.5 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Outcome measures

Measure	Lacosamide n=24 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit pH= 5.0	10 Participants
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit pH= 6.0	7 Participants
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit pH= 6.5	5 Participants
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit pH= 7.0	0 Participants
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit pH= 7.5	0 Participants
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit pH= 8.0	1 Participants
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit pH= 8.5	0 Participants
Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit not done	1 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 7.0 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Outcome measures

Measure	Lacosamide n=8 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit pH= 5.0	4 Participants
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit pH= 6.0	3 Participants
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit pH= 6.5	1 Participants
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit pH= 7.0	0 Participants
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit pH= 7.5	0 Participants
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit pH= 8.0	0 Participants
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit pH= 8.5	0 Participants
Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 7.5 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Outcome measures

Measure	Lacosamide n=6 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit pH= 5.0	3 Participants
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit pH= 6.0	0 Participants
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit pH= 6.5	3 Participants
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit pH= 7.0	0 Participants
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit pH= 7.5	0 Participants
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit pH= 8.0	0 Participants
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit pH= 8.5	0 Participants
Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 8.0 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Outcome measures

Measure	Lacosamide n=1 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit pH= 5.0	0 Participants
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit pH= 6.0	0 Participants
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit pH= 6.5	1 Participants
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit pH= 7.0	0 Participants
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit pH= 7.5	0 Participants
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit pH= 8.0	0 Participants
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit pH= 8.5	0 Participants
Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine White Blood Cell Count 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=344 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit negative	321 Participants
Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit trace	7 Participants
Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive +	3 Participants
Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive ++	5 Participants
Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive +++	1 Participants
Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit not done	7 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine White Blood Cell Count 'Trace' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=15 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit negative	13 Participants
Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit trace	1 Participants
Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive +	0 Participants
Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive ++	0 Participants
Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive +++	1 Participants
Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine White Blood Cell Count 'Positive +' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=6 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit negative	3 Participants
Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit trace	2 Participants
Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive +	0 Participants
Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive ++	1 Participants
Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive +++	0 Participants
Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine White Blood Cell Count 'Positive ++' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=6 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit negative	3 Participants
Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit trace	0 Participants
Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive +	2 Participants
Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive ++	1 Participants
Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit positive +++	0 Participants
Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Nitrite status 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=365 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Nitrite Status 'Negative' at Baseline, Categorized by Urine Nitrite Status at Last Visit negative	353 Participants
Number of Subjects With Urine Nitrite Status 'Negative' at Baseline, Categorized by Urine Nitrite Status at Last Visit positive	5 Participants
Number of Subjects With Urine Nitrite Status 'Negative' at Baseline, Categorized by Urine Nitrite Status at Last Visit not done	7 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Nitrite status 'Positive' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=6 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Nitrite Status 'Positive' at Baseline, Categorized by Urine Nitrite Status at Last Visit negative	3 Participants
Number of Subjects With Urine Nitrite Status 'Positive' at Baseline, Categorized by Urine Nitrite Status at Last Visit positive	3 Participants
Number of Subjects With Urine Nitrite Status 'Positive' at Baseline, Categorized by Urine Nitrite Status at Last Visit not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Urobilinogen value 3 µmol/l at baseline are included in the analysis.

Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).

Outcome measures

Measure	Lacosamide n=361 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 3 µmol/l	351 Participants
Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 16 µmol/l	3 Participants
Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 33 µmol/l	0 Participants
Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 66 µmol/l	0 Participants
Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit Not done	7 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Urobilinogen value 16 µmol/l at baseline are included in the analysis.

Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).

Outcome measures

Measure	Lacosamide n=9 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 3 µmol/l	7 Participants
Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 16 µmol/l	1 Participants
Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 33 µmol/l	1 Participants
Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 66 µmol/l	0 Participants
Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit Not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Urobilinogen value 66 µmol/l at baseline are included in the analysis.

Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).

Outcome measures

Measure	Lacosamide n=1 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 3 µmol/l	1 Participants
Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 16 µmol/l	0 Participants
Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 33 µmol/l	0 Participants
Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit 66 µmol/l	0 Participants
Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit Not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Protein status 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=317 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit Negative	292 Participants
Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit Trace	13 Participants
Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit Positive +	3 Participants
Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit Positive ++	1 Participants
Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit Positive +++	2 Participants
Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit Not done	6 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Protein status 'Trace' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=39 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit Negative	27 Participants
Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit Trace	7 Participants
Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit Positive +	4 Participants
Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit Positive ++	0 Participants
Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit Positive +++	0 Participants
Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit Not done	1 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Protein status 'Positive +' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=7 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit Negative	3 Participants
Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit Trace	1 Participants
Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit Positive +	1 Participants
Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit Positive ++	2 Participants
Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit Positive +++	0 Participants
Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit Not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Protein status 'Positive ++' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=6 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit Negative	2 Participants
Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit Trace	0 Participants
Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit Positive +	3 Participants
Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit Positive ++	0 Participants
Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit Positive +++	1 Participants
Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit Not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Blood status 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=345 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit Negative	319 Participants
Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit Trace (N)	7 Participants
Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit Trace (H)	1 Participants
Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit Positive +	3 Participants
Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit Positive ++	4 Participants
Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit Positive +++	4 Participants
Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit Not done	7 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Blood status 'Trace (N)' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=17 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit Negative	14 Participants
Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit Trace (N)	2 Participants
Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit Trace (H)	0 Participants
Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit Positive +	1 Participants
Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit Positive ++	0 Participants
Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit Positive +++	0 Participants
Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit Not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Blood status 'Trace (H)' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=6 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit Negative	4 Participants
Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit Trace (N)	2 Participants
Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit Trace (H)	0 Participants
Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit Positive +	0 Participants
Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit Positive ++	0 Participants
Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit Positive +++	0 Participants
Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit Not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Blood status 'Positive +' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=1 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit Negative	1 Participants
Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit Trace (N)	0 Participants
Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit Trace (H)	0 Participants
Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit Positive +	0 Participants
Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit Positive ++	0 Participants
Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit Positive +++	0 Participants
Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit Not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Blood status 'Positive ++' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=2 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit Negative	1 Participants
Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit Trace (N)	1 Participants
Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit Trace (H)	0 Participants
Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit Positive +	0 Participants
Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit Positive ++	0 Participants
Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit Positive +++	0 Participants
Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit Not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Ketone status 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

Outcome measures

Measure	Lacosamide n=344 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit Negative	328 Participants
Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit Trace	8 Participants
Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit Small	1 Participants
Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit Moderate	0 Participants
Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit Not done	7 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Ketone status 'Trace' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

Outcome measures

Measure	Lacosamide n=21 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit Negative	19 Participants
Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit Trace	0 Participants
Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit Small	2 Participants
Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit Moderate	0 Participants
Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit Not Done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Ketone status 'Small' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

Outcome measures

Measure	Lacosamide n=4 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit Negative	2 Participants
Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit Trace	2 Participants
Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit Small	0 Participants
Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit Moderate	0 Participants
Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit Not Done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Ketone status 'Moderate' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

Outcome measures

Measure	Lacosamide n=2 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit Negative	2 Participants
Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit Trace	0 Participants
Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit Small	0 Participants
Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit Moderate	0 Participants
Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit Not Done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Bilirubin status 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=360 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Negative	351 Participants
Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Positive +	2 Participants
Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Positive ++	0 Participants
Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Not done	7 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Bilirubin status 'Positive +' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=8 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Negative	8 Participants
Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Positive +	0 Participants
Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Positive ++	0 Participants
Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Bilirubin status 'Positive ++' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=3 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Negative	3 Participants
Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Positive +	0 Participants
Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Positive ++	0 Participants
Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit Not done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value 'Negative' at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).

Outcome measures

Measure	Lacosamide n=266 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit Negative	194 Participants
Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit 5.5 mmol/l	30 Participants
Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit 14 mmol/l	16 Participants
Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit 28 mmol/l	12 Participants
Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit 55 mmol/l	4 Participants
Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit >=111 mmol	6 Participants
Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit Not Done	4 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value 5.5 mmol/l at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).

Outcome measures

Measure	Lacosamide n=37 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit Negative	18 Participants
Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 5.5 mmol/l	15 Participants
Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 14 mmol/l	2 Participants
Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 28 mmol/l	1 Participants
Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 55 mmol/l	0 Participants
Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit >=111 mmol	0 Participants
Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit Not Done	1 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value 14 mmol/l at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).

Outcome measures

Measure	Lacosamide n=18 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit Negative	6 Participants
Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 5.5 mmol/l	8 Participants
Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 14 mmol/l	0 Participants
Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 28 mmol/l	1 Participants
Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 55 mmol/l	2 Participants
Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit >=111 mmol	0 Participants
Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit Not Done	1 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value 28 mmol/l at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).

Outcome measures

Measure	Lacosamide n=20 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit Negative	10 Participants
Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 5.5 mmol/l	3 Participants
Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 14 mmol/l	3 Participants
Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 28 mmol/l	3 Participants
Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 55 mmol/l	0 Participants
Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit >=111 mmol	1 Participants
Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit Not Done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value 55 mmol/l at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).

Outcome measures

Measure	Lacosamide n=19 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit Negative	5 Participants
Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 5.5 mmol/l	5 Participants
Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 14 mmol/l	1 Participants
Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 28 mmol/l	3 Participants
Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 55 mmol/l	1 Participants
Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit >=111 mmol	4 Participants
Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit Not Done	0 Participants

PRIMARY outcome

Timeframe: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value \>=111 mmol/l at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, >= 111 mmol/l, not done (data not available).

Outcome measures

Measure	Lacosamide n=11 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit >=111 mmol	1 Participants
Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit Negative	3 Participants
Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 5.5 mmol/l	2 Participants
Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 14 mmol/l	0 Participants
Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 28 mmol/l	2 Participants
Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit 55 mmol/l	2 Participants
Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit Not Done	1 Participants

PRIMARY outcome

Timeframe: During study period (up to 140 weeks)

Changes in vital signs examination findings is reported as percentage of subjects with marked abnormalities in - Systolic Blood Pressure (SBP) >=180 mmHg and increase of >=20 mmHg - Systolic Blood Pressure >=90 mmHg and decrease of >=20 mmHg - Diastolic Blood Pressure (DBP) >=105 mmHg and increase of >=15 mmHg - Diastolic Blood Pressure >=50 mmHg and decrease of >=15 mmHg - Pulse Rate (PR) >=120 beats/min and increase of >=15 beats/min - Pulse Rate >=50 beats/min and decrease of >=15 beats/min

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment SBP >=180 and increase of >=20 mmHg	7.5 percentage of participants
Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment SBP <=90 and decrease of >=20 mmHg	0.3 percentage of participants
Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment DBP >=105 and increase of >=15 mmHg	3.5 percentage of participants
Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment DBP <=50 and decrease of >=15 mmHg	0.8 percentage of participants
Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment PR >=120 and increase of >=15 beats/min	0.3 percentage of participants
Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment PR <=50 and decrease of >=15 beats/min	0.8 percentage of participants

PRIMARY outcome

Timeframe: Last Visit (up to 140 weeks)

Population: 371 subjects were included in the safety set. Here, Number analyzed signifies those subjects who were evaluable for prespecified categories.

Changes in physical examination findings is reported as percentage of subjects with marked abnormalities in following categories: - Ears, Eyes, Nose, Mouth, Throat - Cardiovascular - Peripheral vascular - Pulmonary - Musculoskeletal - Hepato- / Gastrointestinal - Renal / Genitourological - Neurological - Metabolic / Endocrine - Psychiatric - Hematological / Lymphatic Nodes - Dermatological - Other The percentages are based on the number of subjects with examinations done at each visit for each body system.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Ears, Eyes, Nose, Mouth, Throat	12.2 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Cardiovascular	15.2 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Peripheral vascular	14.2 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Pulmonary	2.1 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Musculoskeletal	13.3 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Hepato- / Gastrointestinal	5.2 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Renal / Genitourological	1.3 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Neurological	49.5 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Metabolic / Endocrine	19.5 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Psychiatric	1.5 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Hematological / Lymphatic Nodes	0.6 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Dermatological	16.7 percentage of participants
Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment. Other	93.3 percentage of participants

PRIMARY outcome

Timeframe: Last Visit (up to 140 weeks)

Population: 371 subjects were included in the safety set. Here, Number analyzed signifies those subjects who were evaluable for prespecified categories.

Changes in neurological examination findings is reported as percentage of subjects with marked abnormalities in following categories: - General - Cranial Nerves - Reflexes - Muscle Strength and Tone - Coordination and Cerebellar Function - Motor System - Sensation: Upper Extremities - Sensation: Lower Extremities The percentages are based on the number of subjects with examinations done at last visit for each category or parameter.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment General	3.6 percentage of participants
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment Cranial Nerves	13.4 percentage of participants
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment Reflexes	69.9 percentage of participants
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment Muscle Strength and Tone	13.4 percentage of participants
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment Coordination and Cerebellar Function	7.0 percentage of participants
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment Motor System	3.7 percentage of participants
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment Sensation: Upper Extremities	21.1 percentage of participants
Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment Sensation: Lower Extremities	87.5 percentage of participants

PRIMARY outcome

Timeframe: Last Visit (up to 140 weeks)

Population: Only subjects with a last visit assessment who had a normal assessment at Baseline where Baseline is defined as the last ECG assessment prior to the first dose of trial medication are included in the analysis.

Changes in 12-lead ECGs is reported as percentage of subjects with abnormal ECG findings categorized in 'Abnormal, possibly insignificant' and 'Abnormal, possibly significant' based on the alert criterion by the ECG vendor and not on the investigator's assessment.

Outcome measures

Measure	Lacosamide n=150 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings Abnormal, possibly insignificant	4.7 percentage of participants
Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings Abnormal, possibly significant	18.0 percentage of participants

PRIMARY outcome

Timeframe: During the study period (up to 140 weeks)

Population: The Safety Set was defined as all subjects who signed the informed consent form and took at least 1 dose of trial medication.

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects Who Withdrew Due to Adverse Events (AEs)	16.4 percentage of participants

PRIMARY outcome

Timeframe: Last Visit (up to 140 weeks)

Population: Only subjects with Urine Protein status 'Positive +++' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Outcome measures

Measure	Lacosamide n=2 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit Negative	0 Participants
Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit Trace	0 Participants
Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit Positive +	0 Participants
Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit Positive ++	1 Participants
Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit Positive +++	1 Participants
Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit Not done	0 Participants

SECONDARY outcome

Timeframe: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

Population: 371 subjects were included in the Safety set. Only subjects with available data for Pain Interference with sleep at the respective visit are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for each visit.

Pain interference scores at each visit (sleep and activity respectively) were defined as the average of the respective daily interference scores during the 7 last available days prior to the corresponding visit. An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms from Baseline. Subjects rated pain interference over the past 12 hours for 7 days prior to each visit and an average value was calculated for each subject.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 2.1	-0.99 units on a scale Standard Deviation 1.614
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 2.2	-1.35 units on a scale Standard Deviation 1.939
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 2.3	-1.77 units on a scale Standard Deviation 1.916
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 2.4	-1.25 units on a scale Standard Deviation 1.218
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 2.5	-1.38 units on a scale Standard Deviation 1.003
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 3	-2.62 units on a scale Standard Deviation 2.166
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 4	-3.05 units on a scale Standard Deviation 2.313
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 5	-3.29 units on a scale Standard Deviation 2.311
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 6	-3.27 units on a scale Standard Deviation 2.269
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 7	-3.37 units on a scale Standard Deviation 2.307
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 8	-3.45 units on a scale Standard Deviation 2.273
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.0	-3.51 units on a scale Standard Deviation 2.328
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.1	-3.44 units on a scale Standard Deviation 2.256
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.2	-3.45 units on a scale Standard Deviation 2.229
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.3	-3.65 units on a scale Standard Deviation 2.154
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.4	-3.56 units on a scale Standard Deviation 2.130
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.5	-3.60 units on a scale Standard Deviation 2.130
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.6	-3.47 units on a scale Standard Deviation 2.247
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.7	-3.54 units on a scale Standard Deviation 2.185
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.8	-3.62 units on a scale Standard Deviation 2.124
Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.9	-3.35 units on a scale Standard Deviation 1.875

SECONDARY outcome

Timeframe: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

Population: 371 subjects were included in the Safety set. Only subjects with available data for Pain Interference with general activity at the respective visit are included in the analysis. Here, Number analyzed signifies those subjects who were who were evaluable for each visit.

Pain interference scores at each visit (sleep and activity respectively) were defined as the average of the respective daily interference scores during the 7 last available days prior to the corresponding visit. An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms from Baseline. Subjects rated pain interference over the past 12 hours for 7 days prior to each visit and an average value was calculated for each subject.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.6	-3.50 units on a scale Standard Deviation 2.263
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.7	-3.53 units on a scale Standard Deviation 2.189
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.8	-3.66 units on a scale Standard Deviation 2.158
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.9	-3.56 units on a scale Standard Deviation 1.703
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 2.1	-0.99 units on a scale Standard Deviation 1.571
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 2.2	-1.38 units on a scale Standard Deviation 1.827
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 2.3	-1.66 units on a scale Standard Deviation 1.962
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 2.4	-1.21 units on a scale Standard Deviation 1.279
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 2.5	-1.62 units on a scale Standard Deviation 0.951
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 3	-2.56 units on a scale Standard Deviation 2.130
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 4	-2.97 units on a scale Standard Deviation 2.273
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 5	-3.14 units on a scale Standard Deviation 2.292
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 6	-3.17 units on a scale Standard Deviation 2.291
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 7	-3.27 units on a scale Standard Deviation 2.321
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 8	-3.32 units on a scale Standard Deviation 2.317
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.0	-3.45 units on a scale Standard Deviation 2.307
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.1	-3.52 units on a scale Standard Deviation 2.221
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.2	-3.50 units on a scale Standard Deviation 2.123
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.3	-3.62 units on a scale Standard Deviation 2.177
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.4	-3.60 units on a scale Standard Deviation 2.129
Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit Visit 9.5	-3.65 units on a scale Standard Deviation 2.116

SECONDARY outcome

Timeframe: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

Population: 371 subjects were included in the Safety set. Only subjects with available data for current pain measured by a 100 mm visual analogue scale (VAS) at the respective visit are included in the analysis. Here, Number of subjects analyzed signifies those subjects who were evaluable for each visit.

A 100 mm visual analogue scale (VAS) was used to assess the subject's current pain. The subject rated their current pain from 0 (no pain) to 100 (worst possible pain). A negative value indicates improvement in symptoms.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 2.1	-12.32 units on a scale Standard Deviation 19.671
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 2.2	-20.79 units on a scale Standard Deviation 23.955
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 2.3	-27.87 units on a scale Standard Deviation 23.218
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 2.4	-14.80 units on a scale Standard Deviation 14.148
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 2.5	-20.33 units on a scale Standard Deviation 14.742
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 3	-35.23 units on a scale Standard Deviation 24.986
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 4	-37.01 units on a scale Standard Deviation 24.952
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 5	-37.91 units on a scale Standard Deviation 24.446
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 6	-37.71 units on a scale Standard Deviation 24.269
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 7	-40.06 units on a scale Standard Deviation 23.653
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 8	-40.25 units on a scale Standard Deviation 23.433
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 9.0	-40.24 units on a scale Standard Deviation 23.739
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 9.1	-41.47 units on a scale Standard Deviation 22.797
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 9.2	-40.08 units on a scale Standard Deviation 24.447
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 9.3	-41.56 units on a scale Standard Deviation 24.140
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 9.4	-41.00 units on a scale Standard Deviation 22.533
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 9.5	-41.45 units on a scale Standard Deviation 23.199
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 9.6	-40.88 units on a scale Standard Deviation 24.142
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 9.7	-41.69 units on a scale Standard Deviation 23.089
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 9.8	-41.83 units on a scale Standard Deviation 23.278
Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS) Visit 9.9	-43.63 units on a scale Standard Deviation 21.543

SECONDARY outcome

Timeframe: Visit 4

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=317 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4 Much Worse	0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4 Moderately Worse	0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4 Mildly Worse	0.9 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4 No Change	6.0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4 Mildly Better	27.1 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4 Moderately Better	32.5 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4 Much Better	33.4 percentage of participants

SECONDARY outcome

Timeframe: Visit 6

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=299 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6 Much Worse	0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6 Moderately Worse	0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6 Mildly Worse	2 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6 No Change	8.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6 Much Better	31.1 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6 Mildly Better	23.7 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6 Moderately Better	34.8 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.0

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=277 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0 Much Worse	0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0 Moderately Worse	0.7 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0 Mildly Worse	1.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0 No Change	6.1 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0 Mildly Better	18.8 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0 Moderately Better	35.7 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.0 Much Better	37.2 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.1

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=269 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1 Much Worse	0.7 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1 Moderately Worse	0.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1 Mildly Worse	2.6 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1 No Change	5.6 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1 Mildly Better	18.2 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1 Moderately Better	37.2 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.1 Much Better	35.3 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.2

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=249 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2 Much Worse	0.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2 Moderately Worse	0.8 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2 Mildly Worse	4.0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2 No Change	4.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2 Mildly Better	17.3 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2 Moderately Better	34.5 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.2 Much Better	38.6 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.3

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=237 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3 Much Worse	0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3 Moderately Worse	1.3 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3 Mildly Worse	3.0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3 No Change	4.2 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3 Mildly Better	20.7 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3 Moderately Better	34.6 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.3 Much Better	36.3 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.4

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=226 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4 Much Worse	0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4 Moderately Worse	0.9 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4 Mildly Worse	4.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4 No Change	5.8 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4 Mildly Better	18.6 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4 Moderately Better	35.0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.4 Much Better	35.4 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.5

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=212 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5 Much Worse	0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5 Moderately Worse	1.9 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5 Mildly Worse	3.3 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5 No Change	6.6 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5 Mildly Better	18.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5 Moderately Better	34.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.5 Much Better	35.4 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.6

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=202 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6 Much Worse	0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6 Moderately Worse	3.0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6 Mildly Worse	1.5 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6 No Change	7.9 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6 Mildly Better	19.3 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6 Moderately Better	31.2 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.6 Much Better	37.1 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.7

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=184 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7 Much Worse	0.5 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7 Moderately Worse	2.2 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7 Mildly Worse	3.8 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7 No Change	6.0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7 Mildly Better	20.1 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7 Moderately Better	31.5 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.7 Much Better	35.9 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.8

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=49 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8 Much Worse	0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8 Moderately Worse	2.0 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8 Mildly Worse	4.1 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8 No Change	8.2 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8 Mildly Better	10.2 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8 Moderately Better	36.7 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 9.8 Much Better	38.8 percentage of participants

SECONDARY outcome

Timeframe: Termination Visit (last treatment visit)

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Outcome measures

Measure	Lacosamide n=329 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit Much Worse	0.9 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit Moderately Worse	2.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit Mildly Worse	3.6 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit No Change	13.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit Mildly Better	20.4 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit Moderately Better	28.6 percentage of participants
Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Termination Visit Much Better	30.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Visit 4

Population: 371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the Neuropathic Pain Symptoms Inventory (NPSI) at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 Burning	-3.1 units on a scale Standard Deviation 3.00
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 Squeezing	-1.5 units on a scale Standard Deviation 3.53
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 Pressure	-2.6 units on a scale Standard Deviation 3.47
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 Electric shocks	-2.3 units on a scale Standard Deviation 3.41
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 Stabbing	-2.6 units on a scale Standard Deviation 3.56
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 Brushing	-1.0 units on a scale Standard Deviation 2.90
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 Increased by pressure	-1.9 units on a scale Standard Deviation 3.49
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 Contact with cold	-1.4 units on a scale Standard Deviation 2.51
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 Pins and needles	-2.7 units on a scale Standard Deviation 3.36
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 4 Tingling	-2.3 units on a scale Standard Deviation 3.58

SECONDARY outcome

Timeframe: Baseline, Visit 6

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=102 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 Electric shocks	-2.5 units on a scale Standard Deviation 3.20
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 Burning	-2.9 units on a scale Standard Deviation 3.28
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 Squeezing	-1.7 units on a scale Standard Deviation 3.35
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 Pressure	-2.5 units on a scale Standard Deviation 3.10
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 Stabbing	-2.6 units on a scale Standard Deviation 3.18
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 Brushing	-1.2 units on a scale Standard Deviation 3.12
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 Increased by pressure	-1.8 units on a scale Standard Deviation 3.36
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 Contact with cold	-1.2 units on a scale Standard Deviation 2.90
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 Pins and needles	-3.3 units on a scale Standard Deviation 2.89
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 6 Tingling	-2.9 units on a scale Standard Deviation 3.58

SECONDARY outcome

Timeframe: Baseline, Visit 9.0

Population: 371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 Burning	-3.0 units on a scale Standard Deviation 2.78
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 Squeezing	-2.2 units on a scale Standard Deviation 3.16
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 Pressure	-2.7 units on a scale Standard Deviation 3.00
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 Electric shocks	-2.9 units on a scale Standard Deviation 3.04
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 Stabbing	-2.9 units on a scale Standard Deviation 3.10
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 Brushing	-1.0 units on a scale Standard Deviation 2.99
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 Increased by pressure	-2.4 units on a scale Standard Deviation 3.13
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 Contact with cold	-1.2 units on a scale Standard Deviation 3.23
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 Pins and needles	-3.2 units on a scale Standard Deviation 3.05
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.0 Tingling	-2.9 units on a scale Standard Deviation 3.20

SECONDARY outcome

Timeframe: Baseline, Visit 9.1

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain), and are reported in categories below and 2 temporal questions (duration of pain, number of pain attacks). This assessment was done only in subjects from countries in which a validated version of the NPSI was available. Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline.

Outcome measures

Measure	Lacosamide n=85 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 Burning	-3.1 units on a scale Standard Deviation 3.33
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 Squeezing	-2.1 units on a scale Standard Deviation 3.20
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 Pressure	-2.8 units on a scale Standard Deviation 3.10
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 Electric shocks	-3.1 units on a scale Standard Deviation 3.36
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 Stabbing	-2.9 units on a scale Standard Deviation 3.17
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 Brushing	-1.0 units on a scale Standard Deviation 2.92
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 Increased by pressure	-2.3 units on a scale Standard Deviation 3.00
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 Contact with cold	-1.4 units on a scale Standard Deviation 2.78
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 Pins and needles	-3.1 units on a scale Standard Deviation 3.25
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.1 Tingling	-2.9 units on a scale Standard Deviation 3.33

SECONDARY outcome

Timeframe: Baseline, Visit 9.2

Population: 371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 Burning	-3.2 units on a scale Standard Deviation 3.11
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 Squeezing	-2.4 units on a scale Standard Deviation 3.15
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 Pressure	-2.7 units on a scale Standard Deviation 3.37
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 Electric shocks	-2.8 units on a scale Standard Deviation 3.41
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 Stabbing	-3.0 units on a scale Standard Deviation 3.35
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 Brushing	-1.0 units on a scale Standard Deviation 2.88
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 Increased by pressure	-2.3 units on a scale Standard Deviation 3.00
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 Contact with cold	-1.7 units on a scale Standard Deviation 2.56
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 Pins and needles	-3.2 units on a scale Standard Deviation 3.18
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.2 Tingling	-3.0 units on a scale Standard Deviation 3.19

SECONDARY outcome

Timeframe: Baseline, Visit 9.3

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=63 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 Burning	-3.1 units on a scale Standard Deviation 3.00
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 Squeezing	-1.9 units on a scale Standard Deviation 2.64
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 Pressure	-2.6 units on a scale Standard Deviation 2.82
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 Electric shocks	-3.0 units on a scale Standard Deviation 3.02
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 Stabbing	-2.8 units on a scale Standard Deviation 3.38
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 Brushing	-0.8 units on a scale Standard Deviation 2.88
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 Increased by pressure	-2.5 units on a scale Standard Deviation 3.13
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 Contact with cold	-1.5 units on a scale Standard Deviation 2.88
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 Pins and needles	-2.9 units on a scale Standard Deviation 3.13
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.3 Tingling	-3.3 units on a scale Standard Deviation 3.44

SECONDARY outcome

Timeframe: Baseline, Visit 9.4

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=62 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 Burning	-2.8 units on a scale Standard Deviation 2.97
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 Squeezing	-1.5 units on a scale Standard Deviation 2.74
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 Pressure	-2.3 units on a scale Standard Deviation 3.01
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 Electric shocks	-2.3 units on a scale Standard Deviation 3.61
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 Stabbing	-2.8 units on a scale Standard Deviation 3.50
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 Brushing	-0.9 units on a scale Standard Deviation 2.93
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 Increased by pressure	-2.2 units on a scale Standard Deviation 2.97
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 Contact with cold	-1.4 units on a scale Standard Deviation 2.76
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 Pins and needles	-2.8 units on a scale Standard Deviation 3.3
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.4 Tingling	-3.1 units on a scale Standard Deviation 3.26

SECONDARY outcome

Timeframe: Baseline, Visit 9.5

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=59 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 Burning	-3.1 units on a scale Standard Deviation 3.09
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 Squeezing	-2.0 units on a scale Standard Deviation 2.86
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 Pressure	-2.4 units on a scale Standard Deviation 2.92
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 Electric shocks	-2.8 units on a scale Standard Deviation 3.20
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 Stabbing	-2.8 units on a scale Standard Deviation 3.36
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 Brushing	-1.0 units on a scale Standard Deviation 2.65
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 Increased by pressure	-2.3 units on a scale Standard Deviation 3.20
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 Contact with cold	-1.6 units on a scale Standard Deviation 2.91
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 Pins and needles	-3.0 units on a scale Standard Deviation 3.20
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.5 Tingling	-3.1 units on a scale Standard Deviation 3.64

SECONDARY outcome

Timeframe: Baseline, Visit 9.6

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=55 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 Burning	-3.0 units on a scale Standard Deviation 3.23
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 Squeezing	-2.0 units on a scale Standard Deviation 3.02
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 Pressure	-2.8 units on a scale Standard Deviation 2.84
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 Electric shocks	-3.1 units on a scale Standard Deviation 3.37
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 Stabbing	-2.8 units on a scale Standard Deviation 3.43
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 Brushing	-0.8 units on a scale Standard Deviation 2.55
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 Increased by pressure	-2.7 units on a scale Standard Deviation 3.04
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 Contact with cold	-1.4 units on a scale Standard Deviation 2.65
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 Pins and needles	-3.1 units on a scale Standard Deviation 3.25
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.6 Tingling	-3.5 units on a scale Standard Deviation 3.31

SECONDARY outcome

Timeframe: Baseline, Visit 9.7

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=53 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 Burning	-3.2 units on a scale Standard Deviation 3.34
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 Squeezing	-2.1 units on a scale Standard Deviation 3.29
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 Pressure	-2.2 units on a scale Standard Deviation 3.31
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 Electric shocks	-2.9 units on a scale Standard Deviation 3.27
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 Stabbing	-2.5 units on a scale Standard Deviation 3.52
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 Brushing	-1.0 units on a scale Standard Deviation 2.87
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 Increased by pressure	-2.5 units on a scale Standard Deviation 3.12
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 Contact with cold	-1.2 units on a scale Standard Deviation 2.79
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 Pins and needles	-3.2 units on a scale Standard Deviation 3.00
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.7 Tingling	-3.3 units on a scale Standard Deviation 3.17

SECONDARY outcome

Timeframe: Baseline, Visit 9.8

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=19 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 Burning	-2.3 units on a scale Standard Deviation 3.43
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 Squeezing	-2.0 units on a scale Standard Deviation 2.89
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 Pressure	-1.7 units on a scale Standard Deviation 2.00
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 Electric shocks	-3.0 units on a scale Standard Deviation 2.65
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 Stabbing	-2.5 units on a scale Standard Deviation 2.82
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 Brushing	-0.4 units on a scale Standard Deviation 2.45
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 Increased by pressure	-1.6 units on a scale Standard Deviation 2.06
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 Contact with cold	-1.4 units on a scale Standard Deviation 1.92
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 Pins and needles	-3.0 units on a scale Standard Deviation 2.94
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Visit 9.8 Tingling	-3.2 units on a scale Standard Deviation 3.15

SECONDARY outcome

Timeframe: Baseline, Termination Visit (last treatment visit)

Population: 371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit Burning	-2.6 units on a scale Standard Deviation 3.47
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit Squeezing	-1.5 units on a scale Standard Deviation 3.20
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit Pressure	-2.0 units on a scale Standard Deviation 3.21
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit Electric shocks	-2.1 units on a scale Standard Deviation 3.54
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit Stabbing	-2.3 units on a scale Standard Deviation 3.45
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit Brushing	-1.0 units on a scale Standard Deviation 3.35
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit Increased by pressure	-1.8 units on a scale Standard Deviation 3.16
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit Contact with cold	-0.7 units on a scale Standard Deviation 3.15
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit Pins and needles	-2.7 units on a scale Standard Deviation 3.36
Change in Different Symptoms of Neuropathic Pain From Visit 2 (Baseline) to Termination Visit Tingling	-2.5 units on a scale Standard Deviation 3.83

SECONDARY outcome

Timeframe: Visit 2 (Baseline)

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=141 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline) Permanently	37.6 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline) Between 8 and 12 h	21.3 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline) Between 4 and 7 h	19.1 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline) Between 1 and 3 h	14.2 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 2 (Baseline) Less than 1 h	7.8 percentage of participants

SECONDARY outcome

Timeframe: Visit 4

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=110 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4 Permanently	10.9 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4 Between 8 and 12 h	13.6 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4 Between 4 and 7 h	17.3 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4 Between 1 and 3 h	20.9 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 4 Less than 1 h	37.3 percentage of participants

SECONDARY outcome

Timeframe: Visit 6

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=103 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6 Permanently	12.6 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6 Between 8 and 12 h	7.8 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6 Between 4 and 7 h	11.7 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6 Between 1 and 3 h	24.3 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 6 Less than 1 h	43.7 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.0

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=90 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0 Permanently	11.1 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0 Between 8 and 12 h	8.9 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0 Between 4 and 7 h	10.0 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0 Between 1 and 3 h	22.2 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.0 Less than 1 h	47.8 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.1

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=86 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1 Permanently	9.3 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1 Between 8 and 12 h	8.1 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1 Between 4 and 7 h	15.1 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1 Between 1 and 3 h	26.7 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1 Less than 1 h	39.5 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.1 Not done	1.2 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.2

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=72 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2 Permanently	5.6 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2 Between 8 and 12 h	9.7 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2 Between 4 and 7 h	8.3 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2 Between 1 and 3 h	22.2 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.2 Less than 1 h	54.2 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.3

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=64 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3 Permanently	3.1 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3 Between 8 and 12 h	3.1 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3 Between 4 and 7 h	15.6 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3 Between 1 and 3 h	28.1 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.3 Less than 1 h	50.0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.4

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=63 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4 Permanently	6.3 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4 Between 8 and 12 h	11.1 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4 Between 4 and 7 h	15.9 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4 Between 1 and 3 h	22.2 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.4 Less than 1 h	44.4 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.5

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=60 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5 Permanently	8.3 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5 Between 8 and 12 h	6.7 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5 Between 4 and 7 h	15.0 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5 Between 1 and 3 h	21.7 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.5 Less than 1 h	48.3 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.6

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=56 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6 Permanently	3.6 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6 Between 8 and 12 h	10.7 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6 Between 4 and 7 h	23.2 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6 Between 1 and 3 h	17.9 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.6 Less than 1 h	44.6 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.7

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=54 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7 Permanently	7.4 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7 Between 8 and 12 h	7.4 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7 Between 4 and 7 h	14.8 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7 Between 1 and 3 h	16.7 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.7 Less than 1 h	53.7 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.8

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=19 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8 Permanently	0 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8 Between 8 and 12 h	10.5 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8 Between 4 and 7 h	26.3 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8 Between 1 and 3 h	26.3 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Visit 9.8 Less than 1 h	36.8 percentage of participants

SECONDARY outcome

Timeframe: Termination Visit (last treatment visit)

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=118 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit Permanently	16.1 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit Between 8 and 12 h	13.6 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit Between 4 and 7 h	16.9 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit Between 1 and 3 h	18.6 percentage of participants
Percentage of Subjects With Presence of Spontaneous Pain Categorized by Duration of Pain at Termination Visit Less than 1 h	34.7 percentage of participants

SECONDARY outcome

Timeframe: Visit 2 (Baseline)

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=141 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline) No pain attack	6.4 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline) Between 1 and 5	33.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline) Between 6 and 10	20.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline) Between 11 and 20	20.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline) More than 20	19.1 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 2 (Baseline) Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 4

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=110 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4 No pain attack	29.1 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4 Between 1 and 5	39.1 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4 Between 6 and 10	20.9 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4 Between 11 and 20	5.5 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4 More than 20	5.5 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 4 Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 6

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=104 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6 No pain attack	26.9 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6 Between 1 and 5	42.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6 Between 6 and 10	20.2 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6 Between 11 and 20	7.7 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6 More than 20	2.9 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 6 Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.0

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=90 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0 No pain attack	36.7 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0 Between 1 and 5	35.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0 Between 6 and 10	20.0 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0 Between 11 and 20	5.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0 More than 20	2.2 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.0 Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.1

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=87 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1 No pain attack	28.7 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1 Between 1 and 5	34.5 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1 Between 6 and 10	20.7 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1 Between 11 and 20	4.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1 More than 20	10.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.1 Not done	1.1 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.2

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=73 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2 No pain attack	27.4 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2 Between 1 and 5	49.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2 Between 6 and 10	9.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2 Between 11 and 20	9.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2 More than 20	4.1 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.2 Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.3

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=63 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3 No pain attack	27.0 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3 Between 1 and 5	44.4 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3 Between 6 and 10	20.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3 Between 11 and 20	3.2 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3 More than 20	4.8 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.3 Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.4

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=63 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4 No pain attack	31.7 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4 Between 1 and 5	33.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4 Between 6 and 10	19.0 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4 Between 11 and 20	11.1 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4 More than 20	4.8 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.4 Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.5

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=60 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5 No pain attack	35.0 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5 Between 1 and 5	35.0 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5 Between 6 and 10	21.7 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5 Between 11 and 20	3.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5 More than 20	5.0 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.5 Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.6

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=56 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6 No pain attack	30.4 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6 Between 1 and 5	44.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6 Between 6 and 10	14.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6 Between 11 and 20	5.4 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6 More than 20	5.4 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.6 Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.7

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=54 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7 No pain attack	33.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7 Between 1 and 5	37.0 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7 Between 6 and 10	16.7 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7 Between 11 and 20	5.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7 More than 20	7.4 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.7 Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Visit 9.8

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=19 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8 No pain attack	26.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8 Between 1 and 5	52.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8 Between 6 and 10	15.8 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8 Between 11 and 20	0 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8 More than 20	5.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Visit 9.8 Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Termination Visit (last treatment visit)

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Outcome measures

Measure	Lacosamide n=118 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit No pain attack	28.8 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit Between 1 and 5	35.6 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit Between 6 and 10	15.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit Between 11 and 20	11.0 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit More than 20	9.3 percentage of participants
Percentage of Subjects With Pain Attacks in Last the 24 Hours Categorized by Number of Pain Attacks at Termination Visit Not done	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Visit 4

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the Short Form-36 (SF-36) Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the physical component Summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 4 Physical Functioning	7.4 units on a scale Standard Deviation 19.99
Change in Quality of Life From Visit 2 (Baseline) to Visit 4 Role-Physical	13.1 units on a scale Standard Deviation 39.88
Change in Quality of Life From Visit 2 (Baseline) to Visit 4 Bodily Pain	20.8 units on a scale Standard Deviation 20.14
Change in Quality of Life From Visit 2 (Baseline) to Visit 4 General health	6.1 units on a scale Standard Deviation 16.18
Change in Quality of Life From Visit 2 (Baseline) to Visit 4 Vitality	8.5 units on a scale Standard Deviation 18.69
Change in Quality of Life From Visit 2 (Baseline) to Visit 4 Social Functioning	8.2 units on a scale Standard Deviation 23.79
Change in Quality of Life From Visit 2 (Baseline) to Visit 4 Role-Emotional	7.1 units on a scale Standard Deviation 45.48
Change in Quality of Life From Visit 2 (Baseline) to Visit 4 Mental Health	5.6 units on a scale Standard Deviation 18.20
Change in Quality of Life From Visit 2 (Baseline) to Visit 4 PCS	5.3 units on a scale Standard Deviation 7.62
Change in Quality of Life From Visit 2 (Baseline) to Visit 4 MCS	2.2 units on a scale Standard Deviation 10.68

SECONDARY outcome

Timeframe: Baseline, Visit 6

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 6 Physical Functioning	8.0 units on a scale Standard Deviation 20.55
Change in Quality of Life From Visit 2 (Baseline) to Visit 6 Role-Physical	12.1 units on a scale Standard Deviation 39.37
Change in Quality of Life From Visit 2 (Baseline) to Visit 6 Bodily Pain	22.4 units on a scale Standard Deviation 21.02
Change in Quality of Life From Visit 2 (Baseline) to Visit 6 General health	7.2 units on a scale Standard Deviation 17.48
Change in Quality of Life From Visit 2 (Baseline) to Visit 6 Vitality	8.4 units on a scale Standard Deviation 17.80
Change in Quality of Life From Visit 2 (Baseline) to Visit 6 Social Functioning	8.4 units on a scale Standard Deviation 24.47
Change in Quality of Life From Visit 2 (Baseline) to Visit 6 Role-Emotional	8.2 units on a scale Standard Deviation 45.11
Change in Quality of Life From Visit 2 (Baseline) to Visit 6 Mental Health	5.0 units on a scale Standard Deviation 17.79
Change in Quality of Life From Visit 2 (Baseline) to Visit 6 PCS	5.7 units on a scale Standard Deviation 8.13
Change in Quality of Life From Visit 2 (Baseline) to Visit 6 MCS	2.2 units on a scale Standard Deviation 10.66

SECONDARY outcome

Timeframe: Baseline, Visit 9.0

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 Physical Functioning	10.4 units on a scale Standard Deviation 21.86
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 Role-Physical	17.5 units on a scale Standard Deviation 41.17
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 Bodily Pain	25.3 units on a scale Standard Deviation 20.54
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 General health	8.8 units on a scale Standard Deviation 16.56
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 Vitality	10.5 units on a scale Standard Deviation 18.89
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 Social Functioning	10.3 units on a scale Standard Deviation 25.41
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 Role-Emotional	12.1 units on a scale Standard Deviation 49.96
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 Mental Health	5.0 units on a scale Standard Deviation 18.01
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 PCS	7.1 units on a scale Standard Deviation 7.90
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.0 MCS	2.6 units on a scale Standard Deviation 11.39

SECONDARY outcome

Timeframe: Baseline, Visit 9.1

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 Physical Functioning	10.6 units on a scale Standard Deviation 20.97
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 Role-Physical	18.4 units on a scale Standard Deviation 39.92
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 Bodily Pain	24.6 units on a scale Standard Deviation 20.45
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 General health	7.3 units on a scale Standard Deviation 17.95
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 Vitality	9.6 units on a scale Standard Deviation 18.66
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 Social Functioning	10.6 units on a scale Standard Deviation 23.58
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 Role-Emotional	14.7 units on a scale Standard Deviation 47.66
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 Mental Health	5.6 units on a scale Standard Deviation 17.83
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 PCS	6.7 units on a scale Standard Deviation 8.18
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.1 MCS	3.0 units on a scale Standard Deviation 10.83

SECONDARY outcome

Timeframe: Baseline, Visit 9.2

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 Physical Functioning	9.6 units on a scale Standard Deviation 21.54
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 Role-Physical	19.2 units on a scale Standard Deviation 42.94
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 Bodily Pain	23.8 units on a scale Standard Deviation 21.33
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 General health	6.7 units on a scale Standard Deviation 18.83
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 Vitality	9.7 units on a scale Standard Deviation 19.08
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 Social Functioning	9.9 units on a scale Standard Deviation 24.79
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 Role-Emotional	13.9 units on a scale Standard Deviation 48.28
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 Mental Health	6.7 units on a scale Standard Deviation 18.18
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 PCS	6.3 units on a scale Standard Deviation 8.31
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.2 MCS	3.3 units on a scale Standard Deviation 11.39

SECONDARY outcome

Timeframe: Baseline, Visit 9.3

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 Physical Functioning	10.3 units on a scale Standard Deviation 21.03
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 Role-Physical	20.2 units on a scale Standard Deviation 42.35
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 Bodily Pain	26.3 units on a scale Standard Deviation 21.60
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 General health	8.3 units on a scale Standard Deviation 17.29
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 Vitality	9.9 units on a scale Standard Deviation 18.40
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 Social Functioning	9.8 units on a scale Standard Deviation 24.74
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 Role-Emotional	14.8 units on a scale Standard Deviation 50.82
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 Mental Health	5.1 units on a scale Standard Deviation 18.52
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 PCS	7.2 units on a scale Standard Deviation 8.03
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.3 MCS	2.7 units on a scale Standard Deviation 11.76

SECONDARY outcome

Timeframe: Baseline, Visit 9.4

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 Physical Functioning	9.3 units on a scale Standard Deviation 21.35
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 Role-Physical	17.3 units on a scale Standard Deviation 45.59
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 Bodily Pain	24.1 units on a scale Standard Deviation 22.76
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 General health	6.8 units on a scale Standard Deviation 18.43
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 Vitality	8.7 units on a scale Standard Deviation 19.70
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 Social Functioning	9.0 units on a scale Standard Deviation 28.04
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 Role-Emotional	12.1 units on a scale Standard Deviation 49.30
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 Mental Health	5.0 units on a scale Standard Deviation 18.17
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 PCS	6.4 units on a scale Standard Deviation 8.63
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.4 MCS	2.4 units on a scale Standard Deviation 11.74

SECONDARY outcome

Timeframe: Baseline, Visit 9.5

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 Physical Functioning	8.6 percentage of participants Standard Deviation 20.88
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 Role-Physical	19.1 percentage of participants Standard Deviation 45.41
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 Bodily Pain	25.9 percentage of participants Standard Deviation 22.49
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 General health	7.9 percentage of participants Standard Deviation 18.64
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 Vitality	7.5 percentage of participants Standard Deviation 18.55
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 Social Functioning	8.2 percentage of participants Standard Deviation 25.00
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 Role-Emotional	9.9 percentage of participants Standard Deviation 51.74
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 Mental Health	3.7 percentage of participants Standard Deviation 17.51
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 PCS	7.0 percentage of participants Standard Deviation 8.53
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.5 MCS	1.4 percentage of participants Standard Deviation 11.29

SECONDARY outcome

Timeframe: Baseline, Visit 9.6

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 Physical Functioning	8.6 units on a scale Standard Deviation 21.46
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 Role-Physical	18.4 units on a scale Standard Deviation 46.02
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 Bodily Pain	24.8 units on a scale Standard Deviation 22.45
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 General health	7.0 units on a scale Standard Deviation 18.18
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 Vitality	7.9 units on a scale Standard Deviation 18.39
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 Social Functioning	8.8 units on a scale Standard Deviation 24.60
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 Role-Emotional	12.7 units on a scale Standard Deviation 48.39
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 Mental Health	4.9 units on a scale Standard Deviation 18.78
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 PCS	6.5 units on a scale Standard Deviation 8.79
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.6 MCS	2.3 units on a scale Standard Deviation 11.51

SECONDARY outcome

Timeframe: Baseline, Visit 9.7

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 Physical Functioning	9.4 units on a scale Standard Deviation 21.60
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 Role-Physical	18.6 units on a scale Standard Deviation 46.18
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 Bodily Pain	25.3 units on a scale Standard Deviation 22.4
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 General Health	7.1 units on a scale Standard Deviation 19.13
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 Vitality	7.4 units on a scale Standard Deviation 19.87
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 Social Functioning	8.7 units on a scale Standard Deviation 26.12
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 Role-Emotional	8.2 units on a scale Standard Deviation 54.47
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 Mental Health	4.3 units on a scale Standard Deviation 17.44
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 PCS	7.0 units on a scale Standard Deviation 8.62
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.7 MCS	1.4 units on a scale Standard Deviation 11.93

SECONDARY outcome

Timeframe: Baseline, Visit 9.8

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 Physical Functioning	6.9 units on a scale Standard Deviation 23.22
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 Role-Physical	2.0 units on a scale Standard Deviation 41.09
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 Bodily Pain	22.2 units on a scale Standard Deviation 20.13
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 General health	0.2 units on a scale Standard Deviation 20.85
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 Vitality	3.2 units on a scale Standard Deviation 22.95
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 Social Functioning	4.3 units on a scale Standard Deviation 26.21
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 Role-Emotional	-7.5 units on a scale Standard Deviation 52.38
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 Mental Health	3.3 units on a scale Standard Deviation 19.48
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 PCS	4.6 units on a scale Standard Deviation 8.33
Change in Quality of Life From Visit 2 (Baseline) to Visit 9.8 MCS	-0.9 units on a scale Standard Deviation 12.92

SECONDARY outcome

Timeframe: Baseline, Termination Visit (last treatment visit)

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Outcome measures

Measure	Lacosamide n=371 Participants Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit Physical Functioning	5.0 units on a scale Standard Deviation 22.90
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit Role-Physical	7.8 units on a scale Standard Deviation 41.56
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit Bodily Pain	19.3 units on a scale Standard Deviation 23.63
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit General Health	4.1 units on a scale Standard Deviation 18.72
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit Vitality	4.5 units on a scale Standard Deviation 18.96
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit Social Functioning	4.2 units on a scale Standard Deviation 25.94
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit Role-Emotional	2.5 units on a scale Standard Deviation 51.05
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit Mental Health	1.2 units on a scale Standard Deviation 18.72
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit PCS	4.7 units on a scale Standard Deviation 8.44
Change in Quality of Life From Visit 2 (Baseline) to Termination Visit MCS	0.1 units on a scale Standard Deviation 11.41

Adverse Events

Lacosamide

Serious events: 83 serious events

Other events: 229 other events

Deaths: 7 deaths

Serious adverse events

Measure	Lacosamide n=371 participants at risk Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Myocardial infarction	0.81% 3/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Angina pectoris	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Myocardial ischaemia	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Coronary artery disease	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Arteriosclerosis coronary artery	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Pericardial haemorrhage	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Cardio-respiratory arrest	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Cardiac failure	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Bundle branch block right	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Bundle branch block left	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Atrial fibrillation	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Aortic valve stenosis	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Acute myocardial infarction	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Cardiac disorders Cardiac failure acute	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Ear and labyrinth disorders Vestibular disorder	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Endocrine disorders Primary hyperaldosteronism	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Eye disorders Retinal detachment	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Eye disorders Diabetic retinopathy	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Eye disorders Cataract	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Eye disorders Vitreous haemorrhage	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Eye disorders Eye haemorrhage	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Eye disorders Diplopia	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Eye disorders Cataract diabetic	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Eye disorders Corneal degeneration	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Gastrointestinal disorders Umbilical hernia	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Gastrointestinal disorders Pancreatitis acute	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Gastrointestinal disorders Pancreatitis	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Gastrointestinal disorders Gastritis erosive	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Gastrointestinal disorders Abdominal hernia	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Gastrointestinal disorders Gastric haemorrhage	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
General disorders Chest pain	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
General disorders Non-cardiac chest pain	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
General disorders Multi-organ failure	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Hepatobiliary disorders Cholelithiasis	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Hepatobiliary disorders Biliary colic	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Infections and infestations Appendicitis	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Infections and infestations Urinary tract infection	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Infections and infestations Prostatic abscess	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Infections and infestations Postoperative wound infection	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Infections and infestations Hepatitis B	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Infections and infestations Gastroenteritis	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Infections and infestations Diabetic gangrene	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Infections and infestations Cellulitis	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Infections and infestations Pneumonia	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Injury, poisoning and procedural complications Lower limb fracture	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Injury, poisoning and procedural complications Fall	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Injury, poisoning and procedural complications Pubic rami fracture	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Injury, poisoning and procedural complications Joint sprain	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Injury, poisoning and procedural complications Head injury	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Injury, poisoning and procedural complications Brain herniation	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Injury, poisoning and procedural complications Ankle fracture	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Investigations Investigation	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Investigations Echocardiogram abnormal	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Metabolism and nutrition disorders Diabetes mellitus	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Metabolism and nutrition disorders Hyperglycaemia	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Metabolism and nutrition disorders Diabetic foot	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Metabolism and nutrition disorders Diabetes mellitus non-insulin- dependent	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Musculoskeletal and connective tissue disorders Toe deformity	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Cerebrovascular accident	0.81% 3/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Carotid artery stenosis	0.54% 2/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Neuritis	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Dizziness	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Transient ischaemic attack	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Syncope vasovagal	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Presyncope	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Neuralgia	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Lumbosacral plexus lesion	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Headache	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Cerebral haemorrhage	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Brain oedema	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Syncope	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Psychiatric disorders Suicide attempt	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Psychiatric disorders Mental disorder	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Psychiatric disorders Depression	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Renal and urinary disorders Renal failure	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Reproductive system and breast disorders Menorrhagia	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Surgical and medical procedures Stent placement	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Surgical and medical procedures Gastric banding	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Vascular disorders Hypertension	0.81% 3/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Vascular disorders Circulatory collapse	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Vascular disorders Phlebitis	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Vascular disorders Peripheral arterial occlusive disease	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Vascular disorders Hypotension	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Vascular disorders Hypertensive crisis	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Vascular disorders Femoral arterial stenosis	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Vascular disorders Arterial haemorrhage	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Vascular disorders Shock haemorrhagic	0.27% 1/371 • From Baseline through Safety follow up visit (up to 140 weeks)

Other adverse events

Measure	Lacosamide n=371 participants at risk Subjects received lacosamide 100 mg/day (50 mg twice daily), orally which was up titrated in increments of 100 mg up to a maximum optimal dose of 400 mg/day during Titration Phase (Weeks 1 to 4). Subjects entered Maintenance Phase after the optimal dose was achieved and received it for up to a maximum of 140 weeks.
Infections and infestations Nasopharyngitis	11.6% 43/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Infections and infestations Influenza	5.7% 21/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Musculoskeletal and connective tissue disorders Back pain	7.0% 26/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Dizziness	20.2% 75/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Headache	11.9% 44/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Somnolence	9.2% 34/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Nervous system disorders Tremor	6.5% 24/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Vascular disorders Hypertension	7.0% 26/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Ear and labyrinth disorders Vertigo	12.1% 45/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Gastrointestinal disorders Nausea	13.2% 49/371 • From Baseline through Safety follow up visit (up to 140 weeks)
Gastrointestinal disorders Vomiting	5.7% 21/371 • From Baseline through Safety follow up visit (up to 140 weeks)
General disorders Fatigue	8.4% 31/371 • From Baseline through Safety follow up visit (up to 140 weeks)
General disorders Oedema peripheral	5.4% 20/371 • From Baseline through Safety follow up visit (up to 140 weeks)

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: UCBCares@ucb.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60