Clinical trial NCT01825837
Conditions: Bipolar I Disorder
Keywords: bipolar I disorder Eslicarbazepine acetate BIA 2-093
Sponsor: Bial - Portela C S.A.
Start date: 2006-03-01; Completion date: 2007-06-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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).

Arms: arm 1: BIA 2-093 1800 mg once daily (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). Study medication was administered orally, once daily in the evening. arm 2: BIA 2-093 900 mg once daily (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). Study medication was administered orally, once daily in the evening. arm 3: BIA 2-093 300 mg once daily (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). Study medication was administered orally, once daily in the evening. arm 4: In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
Interventions: intervention 1: BIA 2-093 1800 mg once daily [Group 1 (Part II)] intervention 2: BIA 2-093 900 mg once daily [Group 2 (Part II)] intervention 3: BIA 2-093 300 mg once daily [Group 3 (Part II)] intervention 4: BIA 2-093 900 mg (Part I)
Intervention descriptions: intervention 1: BIA 2-093 1800 mg taken orally in the evening, for 2 weeks intervention 2: BIA 2-093 900 mg taken orally in the evening, for 2 weeks intervention 3: BIA 2-093 300 mg taken orally in the evening, for 2 weeks. intervention 4: In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.

Protocol documents: