Cephalon Inc announced positive results from a phase 4 clinical trial of Nuvigil (armodafinil) Tablets [C-IV] in patients experiencing excessive sleepiness associated with shift work disorder, specifically during the end of their night shifts (ie, 4 AM to 8 AM), including the commute home.
The study data showed statistically significant difference in improvement in overall clinical condition related to late-shift sleepiness in patients receiving Nuvigil compared to the placebo group. This is the largest trial ever conducted in this patient population, with more than 380 patients randomized to treatment with Nuvigil or placebo.
The primary outcome measure of this 6-week, multicenter, double-blind study of Nuvigil (150 mg) was the Clinical Global Impression of Change (CGI-C) scale. The CGI-C in this study asked that the clinician rate the patient’s improvement in overall clinical condition as it related to sleepiness with shift work disorder late in the shift. Using this rating, the percentage of patients taking Nuvigil who experienced improvement from baseline was 77% versus 57% for placebo (p<0.0001). The key secondary outcome was measured using the Global Assessment of Functioning (GAF), a well-recognized assessment of patient functioning found in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Patients receiving Nuvigil showed a 9.5 point improvement over baseline in the GAF versus a 5.2 point improvement in the placebo group (p< 0.0001).
The most frequently reported adverse events in this study are consistent with those described in the Nuvigil prescribing information, and include headache, nausea, and insomnia. There were no serious adverse events observed in patients taking Nuvigil in this study, according to information from the company. The first presentation of these data will occur during the Society of General Internal Medicine’s 34th Annual Meeting in May 2011. Additional results also will be submitted for future publications and presented at medical meetings.