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Study Shows Sparlon Significantly Improves ADHD Symptoms in Children and Adolescents
"In this study, children and adolescents treated with once-daily SPARLON showed improvement in ADHD symptoms, including inattention, impulsivity, and hyperactivity, both at school and at home," said Joseph Biederman, M.D., chief, Department of Pediatric Psychopharmacology, Massachusetts General Hospital, professor of Psychiatry at Harvard Medical School, and a lead investigator in the trial. "SPARLON also was associated with a favorable side effect profile."
About the Study
The published study is one of three pivotal studies of SPARLON for the treatment of ADHD in children and adolescents. The nine-week, double-blind, flexible-dose study included 248 children and adolescents with ADHD (ages six to 17 years) who were randomized to either once-daily SPARLON or placebo. The primary endpoint was the teacher/physician-completed ADHD Rating Scale-IV (ADHD-RS-IV) School Version total score. Symptom improvement also was rated using a variety of other scales, including evaluations by parents.
In the study, patients treated with SPARLON showed significantly greater improvement than with placebo in the core symptoms of ADHD at school and home (both p In the study, SPARLON was generally well tolerated and discontinuation rates due to adverse events were not significantly different from placebo. The most common adverse events associated with SPARLON were generally mild to moderate in nature and included insomnia, headache and decreased appetite.
SPARLON is a new dosage form of modafinil, the active ingredient in PROVIGIL(R) (modafinil) Tablets [C-IV], which is approved for the treatment of adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. PROVIGIL is not approved to treat ADHD. Cephalon has submitted data to the FDA requesting approval to market SPARLON for the treatment of ADHD in children and adolescents. The FDA has not yet determined that SPARLON is safe and effective. If approved, SPARLON is expected to be available in early 2006.
Source: Cephalon, Inc.