At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 159 enrolled
Drug / intervention
Lacosamide +1 moredrug
Likely dose
Lacosamide 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Lacosamide and Placebo for Fibromyalgia Syndrome. Completed, enrolled 159 participants across 25 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedNov 2006
Primary CompletionFeb 2008
TodayJul 2026
First PostedNov 22, 2006
Enrollment StartOct 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.6 years ago
Interventions
Lacosamidedrug
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
Placeboother
Matching placebo tablet administered twice daily