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Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: August 29, 2005
Last updated: March 24, 2017
Last verified: March 2017
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: Intervention Model: Single Group Assignment
Masking: No masking
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


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 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
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Please refer to this study by its identifier: NCT00139594

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

Additional Information:
Responsible Party: Novartis Identifier: NCT00139594     History of Changes
Other Study ID Numbers: CLIC477D2303E1
Study First Received: August 29, 2005
Last Updated: March 24, 2017

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

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders processed this record on May 25, 2017