Phase 3 study of Nuvigil for jet lag disorder

Cephalon announced positive results from a Phase 3 clinical trial of Nuvigil (armodafinil) tablets as a treatment for excessive sleepiness associated with jet lag disorder. This trial was a randomized, double-blind, placebo-controlled study of 427 healthy adults who had experienced jet lag symptoms during the previous five years. Participants in the study traveled eastbound from the United States to France where they were then examined at a sleep facility. Clinical efficacy was evaluated using two primary endpoints: an objective assessment — the Multiple Sleep Latency Test (MSLT), and a subjective assessment — the Patient Global Impression of Severity (PGI-S). Patients taking Nuvigil (150 mg) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05].

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