A 52-week, opem- label extension study to evaluate the sahety and tolerability of licarbazepine 750-2500 mg/d in the treatment of manic episodes of bipolar I disorder - D2303E1
Phase 1
- Conditions
- Bipolar I disorder, manic and mixed episodes
- Registration Number
- EUCTR2004-000687-27-CZ
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. written informed consent provided prior to participation in the extension study
2. successful completion of study CLIC477D2303
3. cooperation and willingness to comply with all study requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. premature discontinuation from study CLIC477D2303
2. failure to comply with study CLIC477D2303
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 safety and tolerability of open-label treatment with licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2303, 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.;Primary end point(s): To assess long-term safety and tolerability of licarbazepine 750-2000 mg/d in this extension study, adverse events and serious adverse will be recorded. Further assessments will include physical examination, vital signs, laboratory evaluations, and ECGs.
- Secondary Outcome Measures
Name Time Method