At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 528 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
ESL 400 mgfrom 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.
Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia: a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Placebo, ESL 400 mg, and 2 other interventions for Fibromyalgia. Completed, enrolled 528 participants.
Detailed Summary
This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre, multinational, Phase II study in 528 subjects with pain due to Fibromyalgia syndrome(FMS). Subjects were randomised in a 1:1:1:1 ratio to receive placebo, Eslicarbazepine acetate (ESL) 400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD. The study was carried out as follows.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
Primary CompletionSep 2010
First PostedMar 2013
TodayJul 2026
First PostedMar 29, 2013
Enrollment StartApr 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.3 years ago
Interventions
Placebodrug
Tablets
ESL 400 mgdrug
tablets
ESL 800 mgdrug
tablets
ESL 1200 mgdrug
tablets