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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

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ClinicalTrials.gov Identifier: NCT00238485
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Licarbazepine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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.
Study Start Date : January 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007



Primary Outcome Measures :
  1. Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.


Information from the National Library of Medicine

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

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

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): NCT00238485


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

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00238485     History of Changes
Other Study ID Numbers: CLIC477D2302E1
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by Novartis:
Bipolar I Disorder

Additional relevant MeSH terms:
Disease
Pathologic Processes