Conditions: Attention Deficit Disorder With Hyperactivity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 108
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether TRI102 is effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.

Detailed description:
A Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter, laboratory classroom study. After Screening and Baseline evaluations, eligible subjects are enrolled in the study and entered the open-label phase, dose-optimization phase. TRI102 is taken once daily and subjects undergo dose optimization activities for 5 weeks.

Arms:
arm 1: Active, amphetamine extended-release oral suspension arm 2: Placebo

Interventions: intervention 1: TRI102 intervention 2: Placebo
Intervention descriptions: intervention 1: formulation containing active moiety (amphetamine) intervention 2: formulation without active moiety

Protocol document: