An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder.

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00228059
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Duration (Months): 29.9
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar I Disorder	Drug: Licarbazepine	Phase 3

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. written informed consent provided prior to participation in the extension study

2. successful completion of study CLIC477D2301

3. willingness and ability to comply with all study requirements

Exclusion Criteria:

1. premature discontinuation from study CLIC477D2301

2. failure to comply with the study CLIC477D2301 protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site	Cerritos	California	United States

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis Pharmcuticals, Novartis

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• (Click here for further information and to find an investigational site near you)

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00228059
• Other Study ID Numbers: CLIC477D2301E1
• First Posted: Sep 28, 2005
• Last Update Posted: Feb 23, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Novartis: Bipolar disorder, manic episode/treatment/licarbazepine
• Additional relevant MeSH terms: Mania; Disease

Study Results

No Results Posted as of Feb 23, 2017