At a glance
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Extension Study to Investigate the Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate (BIA 2-093) in the Recurrence Prevention of Bipolar I Disorder
In Brief
A Phase 2 clinical trial evaluating BIA 2-093 1800 mg once daily [Group 1 (Part II)], BIA 2-093 900 mg once daily [Group 2 (Part II)], and 2 other interventions for Bipolar I Disorder. Completed, enrolled 104 participants.
Detailed 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.
Study Details
Timeline
Interventions
BIA 2-093 1800 mg taken orally in the evening, for 2 weeks
BIA 2-093 900 mg taken orally in the evening, for 2 weeks
BIA 2-093 300 mg taken orally in the evening, for 2 weeks.
In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.