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

PHASE2CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

June 30, 2007

Study Completion Date

June 30, 2007

Conditions
Bipolar I Disorder
Interventions
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.

All Listed Sponsors
lead

Bial - Portela C S.A.

INDUSTRY

NCT01825837 - Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder | Biotech Hunter | Biotech Hunter