Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD AR11 classroom design amphetamine sulfate
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 97
Healthy volunteers: no

Brief 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.

Detailed description:
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 in the study to take open-label AR11 twice daily 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 the first double-blind treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP assessments. At the end of the second double blind treatment period, patients will be evaluated for ADHD symptoms in a second laboratory classroom setting utilizing SKAMP and PERMP assessments.

Arms:
arm 1: AR11, administered orally, BID, for one week (crossover to placebo administration week 2) arm 2: Placebo, administered orally, BID, for one week (crossover to AR11 administration week 2)

Interventions: intervention 1: AR11 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: