Back to resultsAn 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
Primary Purpose
Bipolar I Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Licarbazepine
Sponsored by
About this trial
This is an interventional diagnostic trial for Bipolar I Disorder focused on measuring Bipolar I Disorder
Eligibility Criteria
Inclusion Criteria: written informed consent provided prior to participation in the extension study. successful completion of the study CLIC477D2302 willingness and ability to comply with all study requirements Exclusion Criteria: premature discontinuation from the study CLIC477D2302 failure to comply with the study CLIC477D2302 protocol
Sites / Locations
Outcomes
Primary Outcome Measures
Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00238485
Brief Title
An 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
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This extension study is designed to investigate the long-term safety and tolerability of licarbazepine 750-2000 mg/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder
Keywords
Bipolar I Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Licarbazepine
Primary Outcome Measure Information:
Title
Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
written informed consent provided prior to participation in the extension study.
successful completion of the study CLIC477D2302
willingness and ability to comply with all study requirements
Exclusion Criteria:
premature discontinuation from the study CLIC477D2302
failure to comply with the study CLIC477D2302 protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Customer Care information
Organizational Affiliation
862-778-8300
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
An 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
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