Phase 2
Completed N=159
Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
Source: ClinicalTrials.gov NCT00401830 ↗Enrolled (actual)
159
Serious AEs
1.9%
Results posted
Oct 2009
Primary outcomePrimary: 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; -1.80 Score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; -1.80 | — |
| PRIMARY 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; -2.40 | — |
| SECONDARY Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase |
-14.7; -17.5 | — |
| SECONDARY Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase |
-6.7; -9.7 | — |
| SECONDARY Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase |
-1.24; -1.64 | — |
| SECONDARY Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase |
-1.27; -1.44 | — |
| SECONDARY Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase |
-1.29; -1.77 | — |
| SECONDARY Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase |
-1.32; -1.84 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase |
8; 17; 14; 12; 18; 13 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase |
-1.1; -0.8; -1.2; -1.2 | — |
| SECONDARY Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase |
83.8; 83.3 | — |
| SECONDARY Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase |
17.5; 15.4 | — |
| SECONDARY Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase |
-1.9; -2.4; -1.7; -1.9; -1.9; -2.4 | — |
| SECONDARY Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 |
9.44 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00401830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.