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NCT00139594 Clinical Trial

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

Bipolar Disorder Clinical Trial

Official title:
A 52-week, Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139594
Other study ID # CLIC477D2303E1
Secondary ID
Status Completed
Phase Phase 4
First received August 29, 2005
Last updated March 24, 2017
Start date December 2004
Est. completion date July 2007

Study information
Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 181
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• licarbazepine

Locations
Country Name City State
Austria Novartis Investigational Site Vienna
Canada Novartis Investigational Site Kelowna
Canada Novartis Investigational Site London
Canada Novartis Investigational Site Montreal
Canada Novartis Investigational Site Sudbury
Canada Novartis Investigator Site Vancouver
Colombia Novartis Investigational Site Bogota
Colombia Novartis Investigational Site Medellin
Colombia Novartis Investigational Site Pareira
Czech Republic Novartis Investigational Site Brno
Czech Republic Novartis Investigational Site Hradec Kralove
Czech Republic Novartis Investigational Site Prague
Germany Novartis Investigational Site Berlin
Germany Novartis Investigational Site Bochum
Germany Novartis Investigational Site Dresden
Germany Novartis Investigational Site Ingolstadt
Germany Novartis Investigational Site Mannheim
Germany Novartis Investigational Site Wurzburg
Guatemala Novartis Investigational Site Guatemala City
Peru Novartis Investigational Site Lima
Russian Federation Novartis Investigational Site Moscow
Russian Federation Novartis Investigational Site Yaroslavl
Slovakia Novartis Investigational Site Bojnice
Slovakia Novartis Investigational Site Michalovce
South Africa Novartis Investigational Site Durban
Ukraine Novartis Investigational Site Dnepropetrovsk
Ukraine Novartis Investigational Site Kiev
Ukraine Novartis Investigational Site Lugansk
Ukraine Novartis Investigational Site Odessa
Ukraine Novartis Investigational Site Simferopol
United States Novartis Investigational Site Bellaire Texas
United States Novartis Investigational Site Bellevue Washington
United States Novartis Investigational Site Dallas Texas
United States Novartis Investigational Site Farmington Hills Michigan
United States Novartis Investigational Site Kansas City Kansas
United States Novartis Investigational Site Kirkland Washington
United States Investigational site La Palma California
United States Novartis Investigational Site Madison Tennessee
United States Novartis Investigational Site Shreveport Louisiana
United States Novartis Investigational Site Somerville Massachusetts
United States Novartis Investigational Site Staten Island New York
United States Novartis Investigational Site Verdun Texas
United States Novartis Investigational site West Allis Wisconsin
Venezuela Novartis Investigational Site Caracas

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Venezuela,  Austria,  Canada,  Colombia,  Czech Republic,  Germany,  Guatemala,  Peru,  Russian Federation,  Slovakia,  South Africa,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of treatment with licarbazepine over 52 weeks.
Primary with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.
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