Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
- Registration Number
- NCT00401830
- Lead Sponsor
- UCB Pharma
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Lacosamide Lacosamide Lacosamide Tablet 400mg daily
- Primary Outcome Measures
Name Time Method 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) Baseline, Last 2 weeks of the 12-week Treatment Phase The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
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) Baseline, Last 2 weeks of the 12-week Treatment Phase The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase Baseline, 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).
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase Baseline, 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.
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase Baseline, 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
Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase Baseline, 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)
Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase Baseline, 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)
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase Baseline, 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 \[score of 7\]).
Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase Baseline, 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.
Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase Baseline, 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).
Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 End of the Maintenance Phase/Week 12 Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase 12-week Treatment Phase Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.
Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase 12-week Treatment Phase Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase Baseline, 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.