An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00228059|
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar I Disorder||Drug: Licarbazepine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
- Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228059
|United States, California|
|Cerritos, California, United States|
|Study Chair:||Novartis Pharmcuticals||Novartis|