EXTENSION STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF ESLICARBAZEPINE ACETATE (BIA 2-093) IN THE RECURRENCE PREVENTION OF BIPOLAR I DISORDER

Conditions: recurrence prevention of bipolar I disorder

Registration Number: EUCTR2005-002134-35-AT

Lead Sponsor: Bial - Portela & Cª, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

Inclusion Criteria

informed consent form signed; completed the 3-week treatment period in Protocol SCO/BIA-2093-203 or Protocol PRA/BIA-2093-204 and shown response to treatment [i.e., = 50% improvement in the Young Mania Rating Scale (YMRS) total score or an YMRS total score < 12]; in case of woman of childbearing potential, patient presents a serum pregnancy test consistent with a non-gravid state and will use double-barrier contraception throughout the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

relevant ECG or laboratory abnormalities; any uncontrolled clinically relevant disorder; not ensured capability to comply with the study protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of Eslicarbazepine Acetate at three different dosage regimens in the recurrence prevention of bipolar I disorder.;Secondary Objective: To evaluate the safety and tolerability of Eslicarbazepine Acetate as maintenance treatment in patients with bipolar I disorder.;Primary end point(s): Proportion of patients showing no worsening according to Clinical Global Impressions - Bipolar Version (CGI-BP) scale over Part II.

Secondary Outcome Measures