Open Label Extension Study 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:
NCT00139594
First received: August 29, 2005
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.


Condition Intervention Phase
Bipolar Disorder
Drug: licarbazepine
Phase 4

Study Type: Interventional
Study Design: 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 in the Treatment of Manic Episodes of Bipolar I Disorder

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of treatment with licarbazepine over 52 weeks.
  • with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.

Enrollment: 181
Study Start Date: December 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: licarbazepine Drug: licarbazepine

  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 study CLIC477D2303
  • cooperation and willingness to comply with all study requirements

Exclusion Criteria:

  • premature discontinuation from study CLIC477D2303
  • failure to comply with study CLIC477D2303
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139594

  Show 44 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00139594     History of Changes
Other Study ID Numbers: CLIC477D2303E
Study First Received: August 29, 2005
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014