An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I Disorder

Novartis251 enrolled

Overview

This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

251

Conditions

Bipolar I Disorder

Interventions

LicarbazepineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * written informed consent provided prior to participation in the extension study. * successful completion of the study CLIC477D2302 * willingness and ability to comply with all study requirements Exclusion Criteria: * premature discontinuation from the study CLIC477D2302 * failure to comply with the study CLIC477D2302 protocol

Outcomes

Primary Outcomes

Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.

Data from ClinicalTrials.gov

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