Phase 2
Completed N=104
Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
Source: ClinicalTrials.gov NCT01825837 ↗Enrolled (actual)
104
Serious AEs
9.2%
Results posted
Jun 2013
Primary outcomePrimary: Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population) — 26; 14; 16 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population) |
26; 14; 16 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01825837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.