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news.A pivotal study evaluating Cephalon's Sparlon tablets for the treatment of attention-deficit/hyperactivity disorder in children and adolescents has produced positive results.
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In the study, one of three pivotal studies of the drug, Sparlon significantly improved the symptoms associated with ADHD as reported by physicians, parents and teachers, and was generally well tolerated.
Patients treated with Sparlon showed significantly greater improvement than with placebo in the core symptoms of ADHD at school and home. By the end of the study, 48% of patients treated with Sparlon were rated by physicians as “much” or “very much” improved compared with 17% of patients who received placebo.
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.
“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 Dr Joseph Biederman, chief of the department of pediatric psychopharmacology, Massachusetts General Hospital, and a lead investigator in the trial.