Conditions: ADHD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 156
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric subjects between 6 to 12 years of age.

Detailed description:

Arms:
arm 1: PRC-063 25, 35, 45, 55, 70 or 85 mg arm 2: None

Interventions: intervention 1: PRC-063 oral capsules intervention 2: Placebo oral capsules
Intervention descriptions: intervention 1: Daily dose intervention 2: Daily dose

Protocol document:
Prot_SAP_000.pdf: 
















Summary statistics will be provided for safety endpoints.