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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.
Information provided by (Responsible Party):
Novartis Identifier:
First received: October 12, 2005
Last updated: March 24, 2017
Last verified: March 2017
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
Intervention Model: Single Group Assignment
Masking: No masking
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)

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00238485

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

Additional Information:
Responsible Party: Novartis Identifier: NCT00238485     History of Changes
Other Study ID Numbers: CLIC477D2302E1
Study First Received: October 12, 2005
Last Updated: March 24, 2017

Keywords provided by Novartis:
Bipolar I Disorder

Additional relevant MeSH terms:
Pathologic Processes processed this record on April 26, 2017