NCT02139111

PRC-063 in Adolescent ADHD

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adolescent ADHD Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Rhodes Pharmaceuticals, L.P. · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.

Detailed description

This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adolescent subjects (12 to 17 years of age inclusive) with ADHD will be randomized to PRC-063 (25, 45, 70 or 85 mg) or placebo for four weeks of double-blind evaluation of safety and efficacy. The study will have four phases: (1) screening and 1-week washout; (2)baseline and double-blind, forced-dose titration over a 2-week period; (3) double-blind evaluation over a 2-week period; and (4) a 14-day safety follow-up. Subjects will be required to visit the site 6 times over a 5 week period. Screening and Washout: Subjects will be screened to establish eligibility for study participation. Subjects who meet eligibility requirements will undergo ADHD medication washout, if applicable.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	Placebo	Oral placebo capsule
DRUG	PRC-063 25 mg	Oral 25 mg capsule - active
DRUG	PRC-063 45 mg	Oral 45 mg capsule - active
DRUG	PRC-063 70 mg	Oral 70 mg capsule - active
DRUG	PRC-063 85 mg	Oral 85 mg capsule - active

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-03-01
• Completion: 2015-05-01
• First posted: 2014-05-15
• Last updated: 2015-07-08

Locations

43 sites across 2 countries: United States, Canada