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
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.
- Secondary Outcome Measures
Name Time Method