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

Phase 3

Completed

• Conditions: Bipolar I Disorder

• Registration Number: NCT00238485
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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