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

Study Overview
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Brief Summary
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This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

Detailed Description
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This was a proof-of-concept study and not powered for statistical comparisons. The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Official Title
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A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400 mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome

Conditions
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Fibromyalgia Syndrome

Intervention / Treatment
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* Drug: Lacosamide
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, 18 to 65 years old Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7 days prior to Baseline) Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50 Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase Exclusion Criteria: Symptomatic regional or structural rheumatic disease Diagnosed neuropathic pain syndrome Receiving treatment with neurostimulating devices Significant psychopathology History of chronic alcohol or drug abuse within 6 months prior to Screening Been hospitalized for psychiatric or behavioral reasons within 6 months prior to Screening Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs) Other medical conditions that could compromise the subject's ability to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Matching placebo tablet administered twice daily<br>|
| Experimental: Lacosamide<br>Lacosamide Tablet 400mg daily | Drug: Lacosamide<br>* Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg<br>* Other names: Harkoseride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced). | Baseline, Last 2 weeks of the 12-week Treatment Phase | 
| 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) | The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced). | Baseline, Last 2 weeks of the 12-week Treatment Phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to 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 | Baseline, Last assessment in the 12-week Treatment Phase | 
| Change From Baseline in Total Myalgic Score to 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. | Baseline, Last assessment in the 12-week Treatment Phase | 
| Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase | Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep) | Baseline, Last 2 weeks of the 12-week Treatment Phase | 
| Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase | General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered) | Baseline, Last 2 weeks of the 12-week Treatment Phase | 
| Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase | An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced). | Baseline, Last 2 weeks of the 12 week Treatment Phase | 
| Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase | An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced). | Baseline, Last 2 weeks of the 12 week Treatment Phase | 
| Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | 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]). | Baseline, Last assessment in the 12-week Treatment Phase | 
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase | 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. | Baseline, Last assessment in the 12-week Treatment Phase | 
| Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase | Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response. | 12-week Treatment Phase | 
| Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase | Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response). | 12-week Treatment Phase | 
| Change From Baseline in Fibromyalgia Symptom Scores to 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. | Baseline, Last assessment in the 12-week Treatment Phase | 
| Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 |  | End of the Maintenance Phase/Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia Syndrome, Lacosamide, Vimpat, Harkoseride