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.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00238485
First received: October 12, 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/d over 52 weeks in patients who completed the 6-week double-blind study CLIC477D2302.


Condition Intervention Phase
Bipolar I Disorder
Drug: Licarbazepine
Phase 3

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

Enrollment: 251
Study Start Date: January 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  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
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: NCT00238485

Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Customer Care information 862-778-8300
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00238485     History of Changes
Other Study ID Numbers: CLIC477D2302E1
Study First Received: October 12, 2005
Last Updated: November 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Bipolar I Disorder

ClinicalTrials.gov processed this record on August 20, 2014