Back to resultsAn Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.
Primary Purpose
Bipolar I Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Licarbazepine
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar I Disorder focused on measuring Bipolar disorder, manic episode/treatment/licarbazepine
Eligibility Criteria
Inclusion Criteria: written informed consent provided prior to participation in the extension study successful completion of study CLIC477D2301 willingness and ability to comply with all study requirements Exclusion Criteria: premature discontinuation from study CLIC477D2301 failure to comply with the study CLIC477D2301 protocol
Sites / Locations
- Investigational Site
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
NCT00228059
Brief Title
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 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/Day in the Treatment of Manic Episodes of Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 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/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.
Detailed Description
A 52-week, open-label extension study to evaluate the safety and tolerability of licarbazepine 750- 2000 mg/day in the treatment of manic episodes of bipolar I disorder
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder
Keywords
Bipolar disorder, manic episode/treatment/licarbazepine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (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 study CLIC477D2301
willingness and ability to comply with all study requirements
Exclusion Criteria:
premature discontinuation from study CLIC477D2301
failure to comply with the study CLIC477D2301 protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmcuticals
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational Site
City
Cerritos
State/Province
California
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.novartisclinicaltrials.com/etrials/DiseaseID10/Bipolar-Disorder-clinical-trials.go
Description
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Learn more about this trial
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.
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