Trial Outcomes & Findings for Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome. (NCT NCT00401830)

NCT ID: NCT00401830

Last Updated: 2018-07-18

Results Overview

The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 159 participants
• Primary outcome timeframe: Baseline, Last 2 weeks of the 12-week Treatment Phase
• Results posted on: 2018-07-18

Participant Flow

Participant milestones

Measure	Placebo Matching placebo tablet (administered twice daily)	Lacosamide Lacosamide Tablet 400mg daily (administered twice daily)
Overall Study STARTED	81	78
Overall Study COMPLETED	50	46
Overall Study NOT COMPLETED	31	32

Reasons for withdrawal

Measure	Placebo Matching placebo tablet (administered twice daily)	Lacosamide Lacosamide Tablet 400mg daily (administered twice daily)
Overall Study Adverse Event	10	18
Overall Study Lack of Efficacy	11	5
Overall Study Withdrawal by Subject	4	3
Overall Study Protocol Violation	3	3
Overall Study Non-compliance with drug study	1	0
Overall Study Lost to Follow-up	1	3
Overall Study Other: Personal / Family problems	1	0

Baseline Characteristics

Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.

Baseline characteristics by cohort

Measure	Placebo n=81 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=78 Participants Lacosamide Tablet 400mg daily (administered twice daily)	Total n=159 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	79 Participants n=5 Participants	76 Participants n=7 Participants	155 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	50.4 years STANDARD_DEVIATION 10.5 • n=5 Participants	48.9 years STANDARD_DEVIATION 11.1 • n=7 Participants	49.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	71 Participants n=7 Participants	148 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	81 participants n=5 Participants	78 participants n=7 Participants	159 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Last 2 weeks of the 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

Outcome measures

Measure	Placebo n=80 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=78 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Full Analysis Set)	-1.30 Score on a scale Standard Deviation 1.92	-1.80 Score on a scale Standard Deviation 2.13

PRIMARY outcome

Timeframe: Baseline, Last 2 weeks of the 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 36 and 41 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.

The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).

Outcome measures

Measure	Placebo n=36 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=41 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Change From Baseline in Average Daily Pain Score to the Last 2 Weeks of the 12-week Treatment Phase (Based on the Per Protocol Set)	-2.11 Score on a scale Standard Deviation 1.98	-2.40 Score on a scale Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline, Last assessment in the 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.

The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia

Outcome measures

Measure	Placebo n=79 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=78 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase	-14.7 Score on a scale Standard Deviation 16.9	-17.5 Score on a scale Standard Deviation 19.3

SECONDARY outcome

Timeframe: Baseline, Last assessment in the 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.

Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.

Outcome measures

Measure	Placebo n=79 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=78 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase	-6.7 Score on a scale Standard Deviation 13.6	-9.7 Score on a scale Standard Deviation 13.0

SECONDARY outcome

Timeframe: Baseline, Last 2 weeks of the 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)

Outcome measures

Measure	Placebo n=80 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=78 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase	-1.24 Score on a scale Standard Deviation 1.94	-1.64 Score on a scale Standard Deviation 2.16

SECONDARY outcome

Timeframe: Baseline, Last 2 weeks of the 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)

Outcome measures

Measure	Placebo n=80 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=78 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase	-1.27 Score on a scale Standard Deviation 1.93	-1.44 Score on a scale Standard Deviation 2.30

SECONDARY outcome

Timeframe: Baseline, Last 2 weeks of the 12 week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).

Outcome measures

Measure	Placebo n=80 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=78 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase	-1.29 Score on a scale Standard Deviation 1.97	-1.77 Score on a scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: Baseline, Last 2 weeks of the 12 week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.

An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).

Outcome measures

Measure	Placebo n=80 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=78 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase	-1.32 Score on a scale Standard Deviation 1.94	-1.84 Score on a scale Standard Deviation 2.15

SECONDARY outcome

Timeframe: Baseline, Last assessment in the 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have this assessment.

The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).

Outcome measures

Measure	Placebo n=67 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=67 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase No change	17 Patients	13 Patients
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase Much better	8 Patients	17 Patients
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase Moderately better	14 Patients	12 Patients
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase Mildly better	18 Patients	13 Patients
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase Mildly worse	5 Patients	3 Patients
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase Moderately worse	2 Patients	6 Patients
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase Much worse	3 Patients	3 Patients

SECONDARY outcome

Timeframe: Baseline, Last assessment in the 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have change from Baseline data for depression. One subject in the Lacosamide group had a missing anxiety score.

The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.

Outcome measures

Measure	Placebo n=67 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=67 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase Depression score (Placebo n=67, Lacosamide n=67)	-1.1 Score on a scale Standard Deviation 2.8	-0.8 Score on a scale Standard Deviation 2.8
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase Anxiety Score (Placebo n=67, Lacosamide n=66)	-1.2 Score on a scale Standard Deviation 3.2	-1.2 Score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.

Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.

Outcome measures

Measure	Placebo n=80 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=78 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase	83.8 Percentage of patients	83.3 Percentage of patients

SECONDARY outcome

Timeframe: 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.

Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).

Outcome measures

Measure	Placebo n=80 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=78 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase	17.5 Percentage of patients	15.4 Percentage of patients

SECONDARY outcome

Timeframe: Baseline, Last assessment in the 12-week Treatment Phase

Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 61 and 60 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.

All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.

Outcome measures

Measure	Placebo n=61 Participants Matching placebo tablet (administered twice daily)	Lacosamide n=60 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Muscular Pain	-1.9 Score on a scale Standard Deviation 2.4	-2.4 Score on a scale Standard Deviation 2.9
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Leg cramps	-1.5 Score on a scale Standard Deviation 2.8	-1.4 Score on a scale Standard Deviation 2.8
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Fatigue	-1.7 Score on a scale Standard Deviation 2.4	-1.9 Score on a scale Standard Deviation 2.9
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Insomnia	-1.9 Score on a scale Standard Deviation 2.7	-2.4 Score on a scale Standard Deviation 3.2
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Joint pains	-1.9 Score on a scale Standard Deviation 2.8	-1.9 Score on a scale Standard Deviation 3.3
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Headaches	-0.7 Score on a scale Standard Deviation 3.2	-1.2 Score on a scale Standard Deviation 3.5
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Restless legs	-1.5 Score on a scale Standard Deviation 2.9	-1.2 Score on a scale Standard Deviation 3.3
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Paresthesias	-1.6 Score on a scale Standard Deviation 2.6	-1.3 Score on a scale Standard Deviation 3.1
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Impaired memory	-1.3 Score on a scale Standard Deviation 2.7	0.0 Score on a scale Standard Deviation 3.1
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Impaired concentration	-1.2 Score on a scale Standard Deviation 3.1	-0.5 Score on a scale Standard Deviation 3.1
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Abdominal pain, alternating diarrhea/constipation	-1.7 Score on a scale Standard Deviation 3.4	-1.2 Score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: End of the Maintenance Phase/Week 12

Population: The number of patients in the Placebo treatment group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 78 patients in the Lacosamide treatment group (Safety Set) data were available at the end of Maintenance Phase/Week 12 for the 45 patients remaining in the study.

Outcome measures

Measure	Placebo Matching placebo tablet (administered twice daily)	Lacosamide n=45 Participants Lacosamide Tablet 400mg daily (administered twice daily)
Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12	—	9.44 ug/ML Standard Deviation 5.24

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 37 other events

Deaths: 0 deaths

Lacosamide

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=81 participants at risk Matching placebo tablet (administered twice daily)	Lacosamide n=78 participants at risk Lacosamide Tablet 400mg daily (administered twice daily)
Infections and infestations Gastroenteritis	1.2% 1/81 • Number of events 1	0.00% 0/78
Metabolism and nutrition disorders Dehydration	1.2% 1/81 • Number of events 1	0.00% 0/78
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.2% 1/81 • Number of events 1	0.00% 0/78
Nervous system disorders Cerebrovascular accident	1.2% 1/81 • Number of events 1	0.00% 0/78

Other adverse events

Measure	Placebo n=81 participants at risk Matching placebo tablet (administered twice daily)	Lacosamide n=78 participants at risk Lacosamide Tablet 400mg daily (administered twice daily)
Eye disorders Vision blurred	1.2% 1/81 • Number of events 1	5.1% 4/78 • Number of events 5
Gastrointestinal disorders Constipation	3.7% 3/81 • Number of events 3	6.4% 5/78 • Number of events 5
Gastrointestinal disorders Diarrhoea	7.4% 6/81 • Number of events 7	6.4% 5/78 • Number of events 5
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/81	5.1% 4/78 • Number of events 4
Gastrointestinal disorders Nausea	14.8% 12/81 • Number of events 13	16.7% 13/78 • Number of events 15
Gastrointestinal disorders Vomiting	4.9% 4/81 • Number of events 4	6.4% 5/78 • Number of events 6
General disorders Fatigue	6.2% 5/81 • Number of events 6	5.1% 4/78 • Number of events 4
Infections and infestations Nasopharyngitis	6.2% 5/81 • Number of events 5	3.8% 3/78 • Number of events 3
Infections and infestations Sinusitis	4.9% 4/81 • Number of events 4	5.1% 4/78 • Number of events 4
Musculoskeletal and connective tissue disorders Back pain	2.5% 2/81 • Number of events 3	5.1% 4/78 • Number of events 5
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/81	5.1% 4/78 • Number of events 4
Nervous system disorders Balance disorder	0.00% 0/81	5.1% 4/78 • Number of events 4
Nervous system disorders Dizziness	9.9% 8/81 • Number of events 9	23.1% 18/78 • Number of events 21
Nervous system disorders Headache	22.2% 18/81 • Number of events 20	20.5% 16/78 • Number of events 16
Nervous system disorders Somnolence	3.7% 3/81 • Number of events 3	6.4% 5/78 • Number of events 5
Psychiatric disorders Anxiety	4.9% 4/81 • Number of events 4	5.1% 4/78 • Number of events 4
Skin and subcutaneous tissue disorders Pruritus	2.5% 2/81 • Number of events 2	9.0% 7/78 • Number of events 7

Additional Information

Study Director

UCB Clinical Trial Call Center

Phone: +1 877 822 9493

Results disclosure agreements

• Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that 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 results shall be published regardless of outcome.
• Publication restrictions are in place

Restriction type: OTHER