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

Completed · Phase 3

Conditions studied: Bipolar I Disorder

In brief

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.

Key facts

Study ID

NCT00228059

Run by

Novartis

People needed

132

Starts

2005-01-01

Expected to finish

2007-07-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• premature discontinuation from study CLIC477D2301
• failure to comply with the study CLIC477D2301 protocol

Where it is running

• Investigational Site — Cerritos, California, United States

Full record on ClinicalTrials.gov

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