NCT01825837

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

Extension Study to Investigate the Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate (BIA 2-093) in the Recurrence Prevention of Bipolar I Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The occurrence of a new manic/depressive episode was considered a treatment failure, and the patient was discontinued from the study. At the end of Part II, 6 months after last patient enrolled and after no longer than approximately 15 months, if patients were still in remission and the investigational product was well-tolerated, patients had the option to enter long-term open-label treatment at the same dosage as used in Part II until a new episode occurred, until marketing was authorized, or until clinical development of BIA 2-093 in the recurrence prevention indication was discontinued. If patients did not enter long-term treatment, an established recurrence prevention medication was prescribed, and BIA 2-093 was tapered off (patients assigned to 1800 mg had the daily dose decreased to 900 mg for 6 days; those assigned to 900 mg or 300 mg received placebo for 6 days).

Conditions

• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	BIA 2-093 1800 mg once daily [Group 1 (Part II)]	BIA 2-093 1800 mg taken orally in the evening, for 2 weeks
DRUG	BIA 2-093 900 mg once daily [Group 2 (Part II)]	BIA 2-093 900 mg taken orally in the evening, for 2 weeks
DRUG	BIA 2-093 300 mg once daily [Group 3 (Part II)]	BIA 2-093 300 mg taken orally in the evening, for 2 weeks.
DRUG	BIA 2-093 900 mg (Part I)	In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2013-04-08
• Last updated: 2014-03-27
• Results posted: 2013-06-17