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.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00228059
First received: September 26, 2005
Last updated: November 22, 2011
Last verified: November 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Enrollment: 132
Study Start Date: January 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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:

  1. written informed consent provided prior to participation in the extension study
  2. successful completion of study CLIC477D2301
  3. willingness and ability to comply with all study requirements

Exclusion Criteria:

  1. premature discontinuation from study CLIC477D2301
  2. failure to comply with the study CLIC477D2301 protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Novartis Pharmcuticals Novartis
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00228059     History of Changes
Other Study ID Numbers: CLIC477D2301E1
Study First Received: September 26, 2005
Last Updated: November 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Bipolar disorder, manic episode/treatment/licarbazepine

Additional relevant MeSH terms:
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014