Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia

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.

Timeline

Start

2009-04

Primary completion

2010-09

Completion

2010-09

Drugs

Indications