Cephalon, Inc. presented positive results from a Phase 4 trial of nearly 400 people with excessive sleepiness associated with shift work disorder. In the trial, NUVIGIL Tablets [C-IV] improved shift-workers’ overall clinical condition late in their shifts (i.e., 4 a.m. to 8 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. Shift work disorder occurs when the body’s internal sleep-wake clock is out of sync with the individual’s work schedule—their bodies tell them to go to sleep when their work schedule needs them to stay awake.
This six-week, double-blind, placebo-controlled study of 383 patients with excessive sleepiness associated with shift work disorder was conducted at 45 sites across the United States. Participants in the study spanned a wide range of occupations associated with shifts or non-traditional work hours, including transportation and material moving, healthcare support, protective services, management roles and office and administrative support. For the primary endpoint, physicians used the Clinical Global Impression of Change (CGI-C) scale to evaluate the change from baseline (beginning of the study) in overall clinical condition late in the shift – from 4 a.m. to 8 a.m. The observation period also included the participant’s commute home from work. Using the CGI-C rating, at the final visit, 77% of patients taking the recommended NUVIGIL dose of 150 mg (n=177) improved, compared to 57% of patients taking placebo (n=182) – a significantly greater improvement.
The key secondary endpoint in this trial was the Global Assessment of Functioning or GAF, a well-recognized assessment of patient functioning found in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, which evaluates an individual’s social, occupational, and psychological functioning on a scale of 1 to 100. Scores above 70 on the Global Assessment of Functioning may be considered within the normal range of functioning. In this trial, physicians used the GAF to measure a patient’s overall level of functioning at baseline and at the final visit. 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.
Release Date: May 6, 2011
Source: Cephalon, Inc.
Filed Under: Drug Discovery