Cephalon has positive results from a phase IV trial of nearly 400 people with excessive sleepiness associated with shift work disorder. In the trial, Nuvigil (armodafinil) tablets improved shift-workers' overall clinical condition late in their shifts (i.e., 4:00 a.m. to 8:00 a.m.), including the commute home, compared to placebo.
The key secondary endpoint of the study was to assess global function, as measured by the Global Assessment of Functioning (GAF), and patients taking Nuvigil experienced a greater improvement in GAF score compared to those patients taking placebo.
At baseline, patients in both the placebo and Nuvigil groups were rated an average score of 63, which is indicative of functional impairment associated with shift work disorder. Patients treated with Nuvigil experienced a 9.5 point improvement over baseline in the Global Assessment of Functioning, to mean scores of 72.6 at the final visit, compared to a 5.2 point improvement to means scores of 67.9 in those taking placebo at final visit (p< 0.0001).