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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:
ClinicalTrials.gov Identifier:
NCT00228059
First Posted: September 28, 2005
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00228059     History of Changes
Other Study ID Numbers: CLIC477D2301E1
First Submitted: September 26, 2005
First Posted: September 28, 2005
Last Update Posted: February 23, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Disease
Pathologic Processes