Clinical trial NCT01820585
Conditions: Fibromyalgia
Keywords: fibromyalgia Eslicarbazepine acetate (BIA 2-093) ESL
Sponsor: Bial - Portela C S.A.
Start date: 2009-04-01; Completion date: 2010-09-01
Enrollment: 528 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre, multinational, Phase II study in 528 subjects with pain due to FMS. Subjects were randomised in a 1:1:1:1 ratio to receive placebo, ESL 400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD. The study was carried out as follows:

Screening Visit (Visit \[V\] 1): After completing screening procedures at V1, eligible subjects began the 2 week Baseline Period.

Baseline Period (2 weeks): Subjects discontinued taking prohibited medications on V1 (beginning of washout period). Subjects were tapered off of discontinued medications. Washout was completed by Day -7 (7 days before V2). Subjects refrained from taking any pain medications and other prohibited medications (except rescue medication) throughout the study. During the Baseline Period, subjects used the subject diary to complete the diary pain assessment on a 0-10 numeric pain rating scale (NPRS) and to record information on rescue medication daily on awakening.

Titration Period (1 week): Upon completing the Baseline Period, subjects returned to the study centre for V2 (Randomisation Visit, Day 1). At V2, subjects, who had completed at least 4 subject diary pain assessments satisfactorily within the past 7 days, had an average pain score that was ≥4 and ≤9 and continued to meet all study entry criteria, were randomly assigned to 1 of the 4 treatment groups. During the 1-week Titration Period, subjects randomised to the ESL 400 mg QD and the ESL 800 mg QD treatment groups received ESL 400 mg QD; and subjects randomised to the ESL 1200 mg QD treatment group received ESL 600 mg QD; subjects assigned to placebo treatment received placebo QD.

Maintenance Period (12 weeks): Starting at V3, subjects assigned to treatment with ESL received their full dosage regimens QD; subjects assigned to placebo treatment received placebo QD. During the Maintenance Period, subjects had visits every 4 weeks.

Follow-up Period (2 weeks): Approximately 2 weeks after taking the last dose of study medication, subjects returned to the study centre for the Follow-up Visit and underwent the end-of-study evaluations.

Arms: arm 1: Tablets arm 2: Eslicarbazepine acetate (BIA 2-093) tablets arm 3: Eslicarbazepine acetate (BIA 2-093) tablets arm 4: Eslicarbazepine acetate (BIA 2-093) tablets
Interventions: intervention 1: Placebo intervention 2: ESL 400 mg intervention 3: ESL 800 mg intervention 4: ESL 1200 mg
Intervention descriptions: intervention 1: Tablets intervention 2: tablets intervention 3: tablets intervention 4: tablets

Protocol documents: