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

NCT01825837 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2014-03-27

Study results available
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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.

Conditions

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.

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Patrício Soares-da-Silva, MD, PhD · BIAL - Portela & Ca. SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-06-30
Completion
2007-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01825837 on ClinicalTrials.gov