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
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: 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 July 28, 2014