NCT02225639

PRC-063 in an ADULT Workplace Environment

A Randomized, Double-blind Study of the Time Course of Response of PRC-063 in Adults With ADHD in a Simulated Adult Workplace Environment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Rhodes Pharmaceuticals, L.P. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the time of onset and time course of efficacy over 16 hours of PRC-063 compared to placebo in adults diagnosed with ADHD in a simulated adult workplace environment (AWE) setting, as measured by the PERMP (an individually-adjusted math test) at pre-dose, 1.0, 2.0, 5.0, 8.0, 11.0, 14.0 and 16.0 hours post-dose.

Detailed description

This is a randomized, double-blind, crossover, placebo-controlled, optimized-dose, phase 3 study to evaluate the safety and efficacy of PRC-063 (methylphenidate hydrochloride controlled-release capsules 25, 35, 45, 55, 70, 85 or 100 mg/day) in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adult subjects greater than or equal to 18 years of age and less than or equal to 60 years of age. After giving written informed consent, subjects will be screened to ascertain their suitability for the study according to the inclusion and exclusion criteria. The study will have four phases: (1) Screening and subsequent washout, if needed; (2) baseline and open-label dose optimization during which subjects will be titrated from a starting dose of 25 mg up to his/her final dose (25, 35, 45, 55, 70, 85 or 100 mg/day); (3) AWE sessions 1 and 2 in the adult analog setting following a practice session; and (4) 14-day safety follow-up. Subjects will be required to visit the clinic up to 10 times over a 9-week period.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	PRC-063 25 mg	Oral 25 mg capsule - active
DRUG	Placebo	Oral placebo capsule
DRUG	PRC-063 35 mg	Oral 35 mg capsule - active
DRUG	PRC-063 45 mg	Oral 45 mg capsule - active
DRUG	PRC-063 55 mg	Oral 55 mg capsule - active
DRUG	PRC-063 70 mg	Oral 70 mg capsule - active
DRUG	PRC-063 85 mg	Oral 85 mg capsule - active
DRUG	PRC-063 100 mg	Oral 100 mg capsule - active

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2014-08-26
• Last updated: 2015-07-09

Locations

2 sites across 1 country: United States