Clinical trial - modafinil in ADHD

Here is a new study just out in the journal Pediatrics using the new formulation of modafinil for ADHD in children (age 6-17) (a formulation for which Cephalon is seeking FDA approval in children). Modafinil is a "wake promoting" drug that is thought to be nonaddictive. The clinical experience in children is growing, but is still limited.In this study, children taking the modafinil showed significant improvements in behavior and no change in any measure of blood chemistry, heart rate, blood pressure, etc. Side effects were insomnia (doses were up to 425 mg/day) and headache. Another difference was that children treated with modafinil lost a small but significant amount of weight (not likely too much of a concern in PWS!). These larger studies showing safety and efficacy in children should be helpful for those who are discussing with their doctors the use of modafinil in children with PWS.

Efficacy and Safety of Modafinil Film Coated Tablets in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: Results of a Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study. Biederman J, Swanson JM, Wigal SB, Kratochvil CJ, Boellner SW, Earl CQ, Jiang J, Greenhill L. Pediatrics. 2005 Dec;116(6):e777-84

For updated information on PWS clinical trial opportunities and to sign up for a monthly PWS Clinical Trial Alert, visit our PWS Clinical Trials page

PWS Clinical Trials

Topics: Research

Theresa Strong


Theresa V. Strong, Ph.D., received a B.S. from Rutgers University and a Ph.D. in Medical Genetics from the University of Alabama at Birmingham (UAB). After postdoctoral studies with Dr. Francis Collins at the University of Michigan, she joined the UAB faculty, leading a research lab focused on gene therapy for cancer and directing UAB’s Vector Production Facility. Theresa is one of the founding members of FPWR and has directed FPWR’s grant program since its inception. In 2016, she transitioned to a full-time position as Director of Research Programs at FPWR. She remains an Adjunct Professor in the Department of Genetics at UAB. She and her husband Jim have four children, including a son with PWS.

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