Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder

Summary

This was an extension study consisting of 2 parts. In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily. Patients stable in remission continued double-blind therapy until approximately 6 months after the last patient entered Part II.

Timeline

Start

2006-03

Primary completion

2007-06

Completion

2007-06

Drugs

Indications