Open Label Extension Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar I Disorder
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
1 other identifier
interventional
181
13 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2004
Typical duration for phase_4
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 31, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedMarch 28, 2017
March 1, 2017
2.6 years
August 29, 2005
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and tolerability of treatment with licarbazepine over 52 weeks.
with respect to the rates of adverse events and serious adverse events, as well as changes in laboratory values, ECGs and vital signs.
Study Arms (1)
licarbazepine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- premature discontinuation from study CLIC477D2303
- failure to comply with study CLIC477D2303
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (44)
Investigational site
La Palma, California, 20623, United States
Novartis Investigational Site
Kansas City, Kansas, United States
Novartis Investigational Site
Shreveport, Louisiana, United States
Novartis Investigational Site
Somerville, Massachusetts, United States
Novartis Investigational Site
Farmington Hills, Michigan, United States
Novartis Investigational Site
Staten Island, New York, United States
Novartis Investigational Site
Madison, Tennessee, United States
Novartis Investigational Site
Bellaire, Texas, United States
Novartis Investigational Site
Dallas, Texas, United States
Novartis Investigational Site
Verdun, Texas, United States
Novartis Investigational Site
Bellevue, Washington, United States
Novartis Investigational Site
Kirkland, Washington, United States
Novartis Investigational site
West Allis, Wisconsin, United States
Novartis Investigational Site
Vienna, Austria
Novartis Investigational Site
Greater Sudbury, Canada
Novartis Investigational Site
Kelowna, Canada
Novartis Investigational Site
London, Canada
Novartis Investigational Site
Montreal, Canada
Novartis Investigator Site
Vancouver, Canada
Novartis Investigational Site
Bogotá, Colombia
Novartis Investigational Site
Medellín, Colombia
Novartis Investigational Site
Pareira, Colombia
Novartis Investigational Site
Brno, Czechia
Novartis Investigational Site
Hradec Králové, Czechia
Novartis Investigational Site
Prague, Czechia
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
Würzburg, Germany
Novartis Investigational Site
Guatemala City, Guatemala
Novartis Investigational Site
Lima, Peru
Novartis Investigational Site
Moscow, Russia
Novartis Investigational Site
Yaroslavl, Russia
Novartis Investigational Site
Bojnice, Slovakia
Novartis Investigational Site
Michalovce, Slovakia
Novartis Investigational Site
Durban, South Africa
Novartis Investigational Site
Dnipro, Ukraine
Novartis Investigational Site
Kiev, Ukraine
Novartis Investigational Site
Luhansk, Ukraine
Novartis Investigational Site
Odesa, Ukraine
Novartis Investigational Site
Simferopol, Ukraine
Novartis Investigational Site
Caracas, Venezuela
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 31, 2005
Study Start
December 1, 2004
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
March 28, 2017
Record last verified: 2017-03