BOCA RATON, FLA. — Children and adolescents with attention-deficit hyperactivity disorder did not experience withdrawal or discontinuation syndrome after abrupt cessation of modafinil film-coated tablets in a phase III, double-blind, multicenter trial.
Researchers also found efficacy as early as 1 week in this 9-week study of 6- to 17-year-olds with attention-deficit hyperactivity disorder (ADHD). The Food and Drug Administration has approved modafinil (Provigil) for treatment of narcolepsy and is currently reviewing a special pediatric formulation for ADHD.
“This is not surprising. Modafinil is a medication that improves vigilance and alertness and could improve similar symptoms in ADHD,” Joseph Biederman, M.D., said in an interview at his poster presentation during a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.
Dr. Biederman and his associates compared efficacy using the school and home versions of the ADHD Rating Scale-IV, the Clinical Global Impression of Improvement (CGI-I) scores, and adverse event reporting by 125 patients taking the pediatric formulation of modafinil and 64 taking a placebo.
The modafinil group had significantly improved school rating total scores, compared with those of the placebo group at 1 week, an effect that was maintained through week 7. The final 2 weeks of the study was a washout phase. Mean reduction from baseline was 17 points with modafinil versus 8 points with placebo. Significant reductions in home rating total scores also were observed with modafinil at all visits, according to Dr. Biederman, chief of the joint program in pediatric psychopharmacology, Massachusetts General Hospital, Boston.
A significantly greater percentage of modafinil patients was rated as “much” or “very much” improved on the CGI-I (49%) than were placebo patients (25%).
Modafinil was abruptly discontinued in 37 patients. Abrupt cessation was not associated with symptom rebound, and no evidence of withdrawal or discontinuation syndrome was seen.
This and other phase III study results were submitted to the FDA in December 2004. “I don't see any reason why they wouldn't approve it,” said Dr. Biederman, who reported no affiliation with Cephalon Inc., the manufacturer and sponsor of the study.