Clinical trial NCT00139594: Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Bipolar disorder, manic episode/treatment/licarbazepine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability of treatment with licarbazepine over 52 weeks.
measure: with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.
Secondary outcomes:
Other outcomes:
Locations:
city: La Palma
country: United States
facility: Investigational site
state: California
city: Kansas City
country: United States
facility: Novartis Investigational Site
state: Kansas
city: Shreveport
country: United States
facility: Novartis Investigational Site
state: Louisiana
city: Somerville
country: United States
facility: Novartis Investigational Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Novartis Investigational Site
state: Michigan
city: Staten Island
country: United States
facility: Novartis Investigational Site
state: New York
city: Madison
country: United States
facility: Novartis Investigational Site
state: Tennessee
city: Bellaire
country: United States
facility: Novartis Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigational Site
state: Texas
city: Verdun
country: United States
facility: Novartis Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Novartis Investigational Site
state: Washington
city: Kirkland
country: United States
facility: Novartis Investigational Site
state: Washington
city: West Allis
country: United States
facility: Novartis Investigational site
state: Wisconsin
city: Vienna
country: Austria
facility: Novartis Investigational Site
city: Kelowna
country: Canada
facility: Novartis Investigational Site
city: London
country: Canada
facility: Novartis Investigational Site
city: Montreal
country: Canada
facility: Novartis Investigational Site
city: Sudbury
country: Canada
facility: Novartis Investigational Site
city: Vancouver
country: Canada
facility: Novartis Investigator Site
city: Bogota
country: Colombia
facility: Novartis Investigational Site
city: Medellin
country: Colombia
facility: Novartis Investigational Site
city: Pareira
country: Colombia
facility: Novartis Investigational Site
city: Brno
country: Czech Republic
facility: Novartis Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: Novartis Investigational Site
city: Prague
country: Czech Republic
facility: Novartis Investigational Site
city: Berlin
country: Germany
facility: Novartis Investigational Site
city: Bochum
country: Germany
facility: Novartis Investigational Site
city: Dresden
country: Germany
facility: Novartis Investigational Site
city: Ingolstadt
country: Germany
facility: Novartis Investigational Site
city: Mannheim
country: Germany
facility: Novartis Investigational Site
city: Wurzburg
country: Germany
facility: Novartis Investigational Site
city: Guatemala City
country: Guatemala
facility: Novartis Investigational Site
city: Lima
country: Peru
facility: Novartis Investigational Site
city: Moscow
country: Russian Federation
facility: Novartis Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigational Site
city: Bojnice
country: Slovakia
facility: Novartis Investigational Site
city: Michalovce
country: Slovakia
facility: Novartis Investigational Site
city: Durban
country: South Africa
facility: Novartis Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: Novartis Investigational Site
city: Kiev
country: Ukraine
facility: Novartis Investigational Site
city: Lugansk
country: Ukraine
facility: Novartis Investigational Site
city: Odessa
country: Ukraine
facility: Novartis Investigational Site
city: Simferopol
country: Ukraine
facility: Novartis Investigational Site
city: Caracas
country: Venezuela
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: