The Efficacy and Safety of PRC-063 in Adult ADHD Patients

ADHD Clinical Trial

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

Status Completed

Clinical Trial 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 adults with ADHD

Clinical Trial Description

This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adult subjects (18 years of age or older) with ADHD will be randomized to PRC-063 (25, 45, 70 or 100 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. ;

Related Conditions & MeSH terms

• ADHD

• NCT number: NCT02139124
• Study type: Interventional
• Source: Rhodes Pharmaceuticals, L.P.
• Status: Completed
• Phase: Phase 3
• Start date: April 2014
• Completion date: January 2015