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NCT00228059 Clinical Trial

An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 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/Day in the Treatment of Manic Episodes of Bipolar I Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00228059
Other study ID # CLIC477D2301E1
Secondary ID
Status Completed
Phase Phase 3
First received September 26, 2005
Last updated February 21, 2017
Start date January 2005
Est. completion date July 2007

Study information
Verified date February 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/day over 52 weeks in patients who completed the 3-week double-blind study CLIC477D2301.

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

Recruitment information / eligibility
Status Completed
Enrollment 132
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:

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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Licarbazepine

Locations
Country Name City State
United States Investigational Site Cerritos California

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

United States, 

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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