Overview

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

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bial - Portela C S.A.
Treatments:
Eslicarbazepine acetate
Criteria
Inclusion Criteria:

- signed the Informed consent form (ICF)

- completed the 3-week treatment period in Protocol with identification number
SCO/BIA-2093-203 or Protocol with identification number PRA/BIA-2093-204 and shown
response to treatment, defined as ≥ 50% improvement in the Young Mania Rating Scale
(YMRS) total score or a YMRS total score < 12

- presented a serum pregnancy test (in cases of women of childbearing potential)
consistent with a non-gravid state and used double-barrier contraception throughout
the study

Exclusion Criteria:

- relevant electrocardiogram (ECG) or laboratory abnormalities

- any uncontrolled clinically relevant disorder

- uninsured capability to comply with the study protocol