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Article: Cephalon Announces Positive Results of PROVIGIL Clinical Study In Shift Work Sleep Disorder.
- Article from:
- PR Newswire
- Article date:
- October 23, 2002
CopyrightCOPYRIGHT 2002 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Company to File Supplemental New Drug Application to Expand PROVIGIL(R) Label
Cephalon, Inc. announced today that results of its clinical study evaluating PROVIGIL(R) (modafinil) C-IV in patients with shift work sleep disorder (SWSD) showed statistical significance on both primary endpoints of the study.
The 12-week randomized double-blind placebo-controlled study included 209 patients with a ICSD-confirmed diagnosis of shift work sleep disorder randomized to either 200 mg PROVIGIL or placebo. The ICSD -- or International Classification of Sleep Disorders -- is widely accepted as a tool for clinical practice and research in sleep disorders medicine.
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