NCT00139594
Completed
Phase 4
A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
ConditionsBipolar Disorder
Interventionslicarbazepine
Overview
- Phase
- Phase 4
- Intervention
- licarbazepine
- Conditions
- Bipolar Disorder
- Sponsor
- Novartis
- Enrollment
- 181
- Locations
- 4
- Primary Endpoint
- Safety and tolerability of treatment with licarbazepine over 52 weeks.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •premature discontinuation from study CLIC477D2303
- •failure to comply with study CLIC477D2303
Arms & Interventions
licarbazepine
Intervention: licarbazepine
Outcomes
Primary Outcomes
Safety and tolerability of treatment with licarbazepine over 52 weeks.
with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.
Study Sites (4)
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