Status:
COMPLETED
Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
Lead Sponsor:
Novartis
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.
Eligibility Criteria
Inclusion
- written informed consent provided prior to participation in the extension study
- successful completion of study CLIC477D2303
- cooperation and willingness to comply with all study requirements
Exclusion
- premature discontinuation from study CLIC477D2303
- failure to comply with study CLIC477D2303
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00139594
Start Date
December 1 2004
End Date
July 1 2007
Last Update
March 28 2017
Active Locations (44)
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1
Investigational site
La Palma, California, United States, 20623
2
Novartis Investigational Site
Kansas City, Kansas, United States
3
Novartis Investigational Site
Shreveport, Louisiana, United States
4
Novartis Investigational Site
Somerville, Massachusetts, United States