Status:
COMPLETED
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.
Lead Sponsor:
Novartis
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 CLIC477D230...
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
Eligibility Criteria
Inclusion
- 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
Exclusion
- premature discontinuation from study CLIC477D2301
- failure to comply with the study CLIC477D2301 protocol
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00228059
Start Date
January 1 2005
End Date
July 1 2007
Last Update
February 23 2017
Active Locations (1)
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1
Investigational Site
Cerritos, California, United States