An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.

Phase 3

Completed

• Conditions: Bipolar I Disorder

• Registration Number: NCT00228059
• Lead Sponsor: Novartis

Brief Summary

This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.

Detailed Description

A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar I disorder

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-26
• Study First Submitted QC: 2005-09-26
• Study First Posted: 2005-09-28
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. written informed consent provided prior to participation in the extension study
2. successful completion of study CLIC477D2301
3. willingness and ability to comply with all study requirements

Exclusion Criteria

1. premature discontinuation from study CLIC477D2301
2. failure to comply with the study CLIC477D2301 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.

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Cerritos, California, United States