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

NCT ID: NCT00238485

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

PHASE3

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar I Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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 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
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 Customer Care information

Role: STUDY_CHAIR

862-778-8300

Other Identifiers

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CLIC477D2302E1

Identifier Type: -

Identifier Source: org_study_id

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