Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in
approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will
enroll to take open-label AR11 BID and undergo dose optimization activities for 8 weeks.
Patients who achieve a stable dose during the dose optimization period will continue
participation and will be randomized to take double-blind medication (AR11 or placebo) orally
twice daily for 1 week. At the end of each double-blind treatment period, patients will be
evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP
assessments.