Trial Outcomes & Findings for A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures (NCT NCT00938431)

NCT ID: NCT00938431

Last Updated: 2019-03-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: 13 weeks
• Results posted on: 2019-03-19

Participant Flow

The SP0847 study began recruitment in October 2009. The study ended in July 2014 with 47 subjects enrolled into the study.

Participant milestones

Measure	>=1 Month to <4 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Overall Study STARTED	15	23	9
Overall Study COMPLETED	9	14	1
Overall Study NOT COMPLETED	6	9	8

Reasons for withdrawal

Measure	>=1 Month to <4 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Overall Study Adverse Event	5	8	6
Overall Study Lack of Efficacy	0	1	0
Overall Study Did not up titrate to 12 mg kg/day	1	0	0
Overall Study Dosing compliance issue	0	0	1
Overall Study Reached maximum dose early	0	0	1

Baseline Characteristics

A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures

Baseline characteristics by cohort

Measure	>=1 Month to <4 Years (Safety Set) n=15 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) n=23 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) n=9 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	Total Title n=47 Participants
Age, Continuous Age (years)	1.58 years STANDARD_DEVIATION 1.02 • n=5 Participants	7.41 years STANDARD_DEVIATION 2.44 • n=7 Participants	15.15 years STANDARD_DEVIATION 1.50 • n=5 Participants	7.03 years STANDARD_DEVIATION 5.12 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	24 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	14 Participants n=7 Participants	4 Participants n=5 Participants	23 Participants n=4 Participants
Weight	9.90 kilograms STANDARD_DEVIATION 3.31 • n=5 Participants	26.73 kilograms STANDARD_DEVIATION 10.20 • n=7 Participants	54.10 kilograms STANDARD_DEVIATION 10.49 • n=5 Participants	26.60 kilograms STANDARD_DEVIATION 17.64 • n=4 Participants
Height	79.64 centimeters STANDARD_DEVIATION 11.22 • n=5 Participants	121.81 centimeters STANDARD_DEVIATION 14.86 • n=7 Participants	158.93 centimeters STANDARD_DEVIATION 11.43 • n=5 Participants	115.46 centimeters STANDARD_DEVIATION 31.23 • n=4 Participants
BMI	15.27 kg/m^2 STANDARD_DEVIATION 2.33 • n=5 Participants	17.39 kg/m^2 STANDARD_DEVIATION 2.68 • n=7 Participants	21.38 kg/m^2 STANDARD_DEVIATION 3.12 • n=5 Participants	17.48 kg/m^2 STANDARD_DEVIATION 3.37 • n=4 Participants
Racial Group Asian	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Racial Group Black	0 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	7 participants n=4 Participants
Racial Group White	7 participants n=5 Participants	18 participants n=7 Participants	5 participants n=5 Participants	30 participants n=4 Participants
Racial Group Other/ Mixed	7 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	8 participants n=4 Participants
Ethnicity Hispanic or Latino	11 participants n=5 Participants	7 participants n=7 Participants	3 participants n=5 Participants	21 participants n=4 Participants
Ethnicity Not Hispanic or Latino	4 participants n=5 Participants	16 participants n=7 Participants	6 participants n=5 Participants	26 participants n=4 Participants

PRIMARY outcome

Timeframe: 13 weeks

Population: The analysis consists of the Safety Set (SS), which is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=15 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) n=23 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) n=9 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment
Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)	14 participants	19 participants	9 participants

SECONDARY outcome

Timeframe: From Baseline to End of Treatment (approximately 13 weeks)

Population: This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=14 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) n=23 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) n=9 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment
Change in Seizure Frequency From Baseline to End of Treatment	18.94 percentage change Standard Deviation 111.44	18.38 percentage change Standard Deviation 88.16	34.59 percentage change Standard Deviation 92.45

SECONDARY outcome

Timeframe: Visit 5 (Day 27/28) or Early Termination

Population: This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study.

For the assessment of the Caregiver Global Impression of Change, the caregiver (including parent/legal guardian) provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of Adverse Events (AEs), and subject's functional status.

The caregiver will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:

1. Very much improved

2. Much improved

3. Minimally improved

4. No change

5. Minimally worse

6. Much worse

7. Very much worse

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=14 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) n=23 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) n=9 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment
Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination Very Much Improved	3 Participants	2 Participants	0 Participants
Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination Much Improved	7 Participants	8 Participants	4 Participants
Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination Minimally Improved	3 Participants	8 Participants	3 Participants
Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination No Change	0 Participants	2 Participants	1 Participants
Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination Miniamally Worse	0 Participants	1 Participants	0 Participants
Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination Much Worse	0 Participants	2 Participants	0 Participants
Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination No data available	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Visit 5 (Day 27/28) or Early Termination

Population: This analysis consists of the Full Analysis Set, which is all subjects from the Safety Set who have at least 1 post-Baseline seizure diary day with available data during the SP0847 study. For one subject in the age group \>=12 years to \<=17 years no data is available.

For assessment of the Clinical Global Impression of Change, the investigator provided his/her assessment of the subject's clinical status, compared to Baseline (Visit 1), including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.

The investigator will be asked to check the number that best describes the subject's condition over the past 4 weeks compared to Baseline:

1. Very much improved

2. Much improved

3. Minimally improved

4. No Change

5. Minimally worse

6. Much worse

7. Very much worse

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=14 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) n=23 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) n=9 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment
Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination Minimally Worse	0 Participants	3 Participants	0 Participants
Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination Very Much Improved	2 Participants	2 Participants	0 Participants
Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination Much Improved	6 Participants	7 Participants	7 Participants
Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination Minimally Improved	4 Participants	9 Participants	1 Participants
Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination No Change	1 Participants	2 Participants	0 Participants
Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination Much Worse	1 Participants	0 Participants	0 Participants
Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination No data available	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 7

Population: The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=45 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Plasma Ctrough Values for Lacosamide at Day 7	839.9 μg/mL Geometric Coefficient of Variation 64.1	—	—

SECONDARY outcome

Timeframe: Day 28

Population: The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=6 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Plasma Ctrough Values for Lacosamide at Day 28	3886.0 μg/mL Geometric Coefficient of Variation 70.2	—	—

SECONDARY outcome

Timeframe: Day 35

Population: The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=5 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Plasma Ctrough Values for Lacosamide at Day 35	4033.8 μg/mL Geometric Coefficient of Variation 52.5	—	—

SECONDARY outcome

Timeframe: Day 42

Population: The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=14 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Plasma Ctrough Values for Lacosamide at Day 42	4169.5 μg/mL Geometric Coefficient of Variation 73.3	—	—

SECONDARY outcome

Timeframe: Day 7

Population: The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=45 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Plasma Ctrough Values for SPM 12809 at Day 7	258.4 μg/mL Geometric Coefficient of Variation 44.6	—	—

SECONDARY outcome

Timeframe: Day 28

Population: The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=6 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Plasma Ctrough Values for SPM 12809 at Day 28	754.9 μg/mL Geometric Coefficient of Variation 21.1	—	—

SECONDARY outcome

Timeframe: Day 35

Population: The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=5 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Plasma Ctrough Values for SPM 12809 at Day 35	955.1 μg/mL Geometric Coefficient of Variation 24.7	—	—

SECONDARY outcome

Timeframe: Day 42

Population: The analysis consists of the Safety Set, which is all subjects who signed the informed consent form and took at least 1 dose of LCM in SP0847. The number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

SPM 12809 is major metabolite of LCM and is known as O-desmethyl-lacosamide. During SP0847, the time points for collection of blood samples for plasma concentration analysis varied per enrollment cohort. To provide a standard summary of this information, we present the mean plasma trough concentrations (Ctrough). Ctrough levels represent the lowest level of LCM that was present in the subject with measurement taken pre-dose before the next scheduled dose of LCM.

The blood sample for plasma concentration schedule varied per enrollment cohort and with protocol amendments. A PK sample was not required for a subject to be in the included in the SS although all subjects did have at least one PK sample taken during SP0847. Therefore the number of subjects presented for the PK assessments is based on the subjects in the SS who attended the respective visits and had PK concentration data at the respective time point.

Outcome measures

Measure	>=1 Month to <4 Years (Safety Set) n=14 Participants Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Plasma Ctrough Values for SPM 12809 at Day 42	1725.8 μg/mL Geometric Coefficient of Variation 39.4	—	—

Adverse Events

>=1 Month to <4 Years (Safety Set)

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

>=4 Years to <12 Years (Safety Set)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

>=12 Years to <=17 Years (Safety Set)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	>=1 Month to <4 Years (Safety Set) n=15 participants at risk Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) n=23 participants at risk Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) n=9 participants at risk Subjects were classified as belonging to the age group based on their age at time of enrollment
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/15 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	4.3% 1/23 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/9 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Infections and infestations Pneumonia viral	6.7% 1/15 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/23 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/9 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/15 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	4.3% 1/23 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/9 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Metabolism and nutrition disorders Dehydration	6.7% 1/15 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/23 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/9 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Nervous system disorders Status epilepticus	13.3% 2/15 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	4.3% 1/23 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/9 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.

Other adverse events

Measure	>=1 Month to <4 Years (Safety Set) n=15 participants at risk Subjects were classified as belonging to the age group based on their age at time of enrollment	>=4 Years to <12 Years (Safety Set) n=23 participants at risk Subjects were classified as belonging to the age group based on their age at time of enrollment	>=12 Years to <=17 Years (Safety Set) n=9 participants at risk Subjects were classified as belonging to the age group based on their age at time of enrollment
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 3 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	30.4% 7/23 • Number of events 7 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	22.2% 2/9 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Gastrointestinal disorders Diarrhoea	13.3% 2/15 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	17.4% 4/23 • Number of events 7 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	11.1% 1/9 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Gastrointestinal disorders Constipation	6.7% 1/15 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	4.3% 1/23 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	11.1% 1/9 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
General disorders Irritability	20.0% 3/15 • Number of events 3 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	4.3% 1/23 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	11.1% 1/9 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
General disorders Pyrexia	13.3% 2/15 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	13.0% 3/23 • Number of events 4 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/9 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
General disorders Gait disturbance	0.00% 0/15 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	8.7% 2/23 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	11.1% 1/9 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Infections and infestations Otitis media	0.00% 0/15 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	13.0% 3/23 • Number of events 3 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/9 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Infections and infestations Pharyngotonsillitis	20.0% 3/15 • Number of events 3 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/23 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	0.00% 0/9 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Nervous system disorders Somnolence	13.3% 2/15 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	13.0% 3/23 • Number of events 3 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	11.1% 1/9 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Nervous system disorders Dizziness	0.00% 0/15 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	13.0% 3/23 • Number of events 4 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	22.2% 2/9 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Nervous system disorders Balance disorder	0.00% 0/15 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	4.3% 1/23 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	22.2% 2/9 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.
Skin and subcutaneous tissue disorders Rash	6.7% 1/15 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	4.3% 1/23 • Number of events 1 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.	22.2% 2/9 • Number of events 2 • Adverse Events (AE) and Serious Adverse Events (SAE) were recorded for the duration of the study (November 2009 - July 2014). The analysis group for AEs and SAEs was the Safety Set. The Safety Set comprised of all subjects who signed the informed consent form and took at least 1 dose of Lacosamide in SP0847.

Additional Information

Study Director

UCB

Phone: +1877 822 9493

Results disclosure agreements

• Principal investigator is a sponsor employee UCB has \> 60 but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
• Publication restrictions are in place

Restriction type: OTHER