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news.Sciele Pharma and Addrenex Pharmaceuticals have announced that the preliminary analysis of the Phase III clinical study investigating the use of Clonicel for the treatment of attention deficit hyperactivity disorder has shown statistically significant improvement over placebo.
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The study has indicated that Clonicel achieved statistical significance on the primary endpoint, which is based on the attention deficit hyperactivity disorder (ADHD) rating scale of 18 symptoms developed by the American Psychiatric Association and used by physicians to classify and diagnose ADHD.
The study was a Phase III, randomized, double-blind, placebo-controlled clinical trial comparing two doses of Clonicel to placebo. The study enrolled 228 children between the ages of six and 17 who had a diagnosis of ADHD.
Children received either placebo or one of two doses of Clonicel, 0.2mg/day or 0.4mg/day, for eight weeks. Adverse events were mild to moderate in severity and no serious adverse events were reported in the study.
Larry Dillaha, chief medical officer of Sciele Pharma, said: “Addrenex is also continuing to enroll patients in an additional Phase III trial using Clonicel in combination with stimulants such as methylphenidate and dextro-amphetamine/amphetamine to treat ADHD.”
Moise Khayrallah, CEO of Addrenex Pharmaceuticals, said: “This is the first Phase III clinical study using Clonicel, an extended-release formulation of clonidine. Clonidine is already approved for hypertension. Clonicel is designed to normalize excess adrenergic hormones that may cause many symptoms of ADHD.”