— Cephalon, Inc. announced results from an investigational, multi-center clinical study in 248 children between the ages of six and 13. The results of the study show that Provigil® (modafinil) Tablets [C-IV] significantly improves symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children.
In the four-week, randomized, double-blind, placebo-controlled, parallel design study, children and adolescents with ADHD were assigned to one of four dose regimens of Provigil daily or placebo. The primary efficacy endpoint measure was the teacher-completed school version of the ADHD Rating Scale IV. All of the Provigil treated groups showed a reduction in symptoms of ADHD, with certain groups reaching statistical significance compared to placebo (p<0.05). The greatest significance was achieved in the group assigned to 300 mg of Provigil once a day (p<0.01).
Provigil was generally well tolerated and the side effects seen in this study were consistent with those described in the product label, with insomnia being the most frequent. The complete study data are expected to be presented at a major medical meeting in 2003. “This was a well-controlled study that provided us with a rich data set into the potential benefits that Provigil may offer in treating children with ADHD,” said Paul Blake, M.D., Senior Vice President of Clinical Research and Regulatory Affairs at Cephalon. “We are excited about the results and look forward to discussing these data with experts in the field and regulators to determine the best path for further development in the area of ADHD.”
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