UK-based specialty pharmaceutical company Shire has reported that its clinical study of Intuniv (guanfacine) extended-release selective alpha-2A-agonist met its primary endpoint in the treatment of oppositional symptoms in children aged six to 12 suffering from attention-deficit hyperactivity disorder.
Subjects in the randomized, placebo-controlled, flexible-dose trial showed a showed a significant improvement in oppositional symptoms, according to: the ADHD Rating Scale IV; the clinical global impressions, improvement scale; the conduct problem subscale of the New York parent rating scale, school-aged; and the parent stress index, short-form questionnaire.
The most commonly-reported emergent adverse events in the study, with occurence of at least 10%, were somnolence, headache, sedation, upper abdominal pain, fatigue and irritability. There were now serious adverse events and most were mild to moderate in severity.
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