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

Completed · Phase 4

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00139594

Run by

Novartis

People needed

181

Starts

2004-12-01

Expected to finish

2007-07-01

Last updated by the study team

2017-03-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Investigational site — La Palma, California, 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

Full record on ClinicalTrials.gov

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