An Open-Label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.

This study has been completed.

First Received: September 26, 2005 Last Updated: December 12, 2007 History of Changes

Sponsors and Collaborators:	Novartis None
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00228059

Purpose

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.

Condition	Intervention	Phase
Bipolar I Disorder	Drug: Licarbazepine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.

Estimated Enrollment:	160
Study Start Date:	January 2005
Study Completion Date:	September 2007

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228059

Locations

United States, California
Investigational Site
Cerritos, California, United States

Sponsors and Collaborators

Novartis

None

Investigators

Study Chair:

Novartis Pharmcuticals

Novartis

More Information

Additional Information:

(Click here for further information and to find an investigational site near you) This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CLIC477D2301E1
Study First Received:	September 26, 2005
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00228059 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Bipolar disorder, manic episode/treatment/licarbazepine

Study placed in the following topic categories:

Bipolar Disorder

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on September 03, 2009