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

Novartis1 site in 1 country132 target enrollmentJanuary 2005

ConditionsBipolar I Disorder

DrugsLicarbazepine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Bipolar I Disorder
Sponsor: Novartis
Enrollment: 132
Locations: 1
Primary Endpoint: Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

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

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

July 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•written informed consent provided prior to participation in the extension study
•successful completion of study CLIC477D2301
•willingness and ability to comply with all study requirements