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

• 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/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.

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

Details

• Lead Sponsor: Novartis

Criteria

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