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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

Criteria

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