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

NCT ID: NCT00139594

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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licarbazepine

Group Type EXPERIMENTAL

licarbazepine

Intervention Type DRUG

Interventions

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licarbazepine

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

* premature discontinuation from study CLIC477D2303
* failure to comply with study CLIC477D2303
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Investigational site

La Palma, California, United States

Site Status

Novartis Investigational Site

Kansas City, Kansas, United States

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Shreveport, Louisiana, United States

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Somerville, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Staten Island, New York, United States

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Madison, Tennessee, United States

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Bellaire, Texas, United States

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Dallas, Texas, United States

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Verdun, Texas, United States

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Bellevue, Washington, United States

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Kirkland, Washington, United States

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West Allis, Wisconsin, United States

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Vienna, , Austria

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Greater Sudbury, , Canada

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Kelowna, , Canada

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London, , Canada

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Montreal, , Canada

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Vancouver, , Canada

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Bogotá, , Colombia

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Medellín, , Colombia

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Pareira, , Colombia

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Brno, , Czechia

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Hradec Králové, , Czechia

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Prague, , Czechia

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Berlin, , Germany

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Bochum, , Germany

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Dresden, , Germany

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Ingolstadt, , Germany

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Mannheim, , Germany

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Würzburg, , Germany

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Guatemala City, , Guatemala

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Lima, , Peru

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Moscow, , Russia

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Yaroslavl, , Russia

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Bojnice, , Slovakia

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Michalovce, , Slovakia

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Durban, , South Africa

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Dnipro, , Ukraine

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Kiev, , Ukraine

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Luhansk, , Ukraine

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Odesa, , Ukraine

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Simferopol, , Ukraine

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Caracas, , Venezuela

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Countries

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United States Austria Canada Colombia Czechia Germany Guatemala Peru Russia Slovakia South Africa Ukraine Venezuela

Other Identifiers

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CLIC477D2303E1

Identifier Type: -

Identifier Source: org_study_id

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