Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

Phase 4

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: licarbazepine

• Registration Number: NCT00139594
• Lead Sponsor: Novartis

Brief Summary

This extension study is designed to assess the long-tem tolerability and safety of licarbazepine in patients who completed the 6-week double-blind study CLIC477D2303.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-31
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

• written informed consent provided prior to participation in the extension study
• successful completion of study CLIC477D2303
• cooperation and willingness to comply with all study requirements

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Exclusion Criteria

• premature discontinuation from study CLIC477D2303
• failure to comply with study CLIC477D2303

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
licarbazepine	licarbazepine	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of treatment with licarbazepine over 52 weeks.
with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.

Trial Locations

Locations (4)

Investigational site; 🇺🇸 La Palma, California, United States

Novartis Investigational Site; 🇻🇪 Caracas, Venezuela

Novartis Investigator Site; 🇨🇦 Vancouver, Canada

Novartis Investigational site; 🇺🇸 West Allis, Wisconsin, United States