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
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 April 17, 2014