Open Label Extension Study 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: NCT00139594|
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : March 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: licarbazepine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 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 in the Treatment of Manic Episodes of Bipolar I Disorder|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
- Safety and tolerability of treatment with licarbazepine over 52 weeks.
- with respect to the rates of adverse events and serious adverse events, as well as 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): NCT00139594
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|