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

This study has been completed.

First Received: October 12, 2005 Last Updated: November 29, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00238485

Purpose

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.

Condition	Intervention	Phase
Bipolar I Disorder	Drug: Licarbazepine	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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.

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:	100
Study Start Date:	December 2005
Study Completion Date:	August 2007

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238485

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Customer Care information

862-778-8300

More Information

No publications provided

Study ID Numbers:	CLIC477D2302E1
Study First Received:	October 12, 2005
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00238485 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Bipolar I Disorder

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on May 07, 2009