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NCT00238485 Clinical Trial

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

Bipolar I Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00238485
Other study ID # CLIC477D2302E1
Secondary ID
Status Completed
Phase Phase 3
First received October 12, 2005
Last updated March 24, 2017
Start date January 2005
Est. completion date July 2007

Study information
Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 251
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Licarbazepine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
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