A 52-week 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
- Conditions
- Bipolar I disorder, manic and mixed episodes
- Registration Number
- EUCTR2004-000686-35-FI
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 215
Inclusion Criteria
•successful completion of study CLIC477D2302
•written informed consent provided prior to participation in the extension study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•premature discontinuation from study CLIC477D2302
•failure to comply with the study CLIC477D2302 protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the tolerability and safety of open-label treatment with licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6 week double- blind study CLIC477D2302, with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.;Secondary Objective: To monitor the efficacy of open-label treatment with licarbazepine 750-2000 mg/d over 52 weeks.<br><br>;Primary end point(s): To assess the tolerability and safety of open-label treatment with licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double- blind study CLIC477D2302, with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.
- Secondary Outcome Measures
Name Time Method