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
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

ClinicalTrials.gov processed this record on April 23, 2014