CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 452 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
ESL 1200 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.

Search/NCT01820559
NCT01820559Phase 2Completed
CompareCT.gov

Efficacy and Safety of Eslicarbazepine Acetate as Preventive Therapy for Subjects With Migraine: a Doubleblind,Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial

Bial - Portela C S.A.·interventional·Posted Mar 29, 2013·Updated May 24, 2013

In Brief

A Phase 2 clinical trial evaluating Placebo, ESL 1200 mg, and 1 other intervention for Migraine. Completed, enrolled 452 participants.

Detailed Summary

This was a multinational, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of multiple doses of ESL as prophylactic treatment in subjects with migraine with or without aura. Subjects were randomised in a 1:1:1 ratio to receive placebo, ESL 800 mg/day once daily (QD), or ESL 1200 mg/day QD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2013
Enrollment StartApr 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.3 years ago

Interventions

Placebodrug

Tablets

ESL 1200 mgdrug

Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route.

ESL 800 mgdrug

Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route.