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

March 24, 2017 updated by: Novartis

A 52-week, 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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and tolerability of licarbazepine with respect to adverse events, serious adverse events, changes in laboratory values, ECGs and vital signs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis Customer Care information, 862-778-8300

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIC477D2302E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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