NCT02168127

Long-Term Safety of PRC-063 in Adolescents and Adults With ADHD

A Six-month, Open-label, Multi-center Study of the Safety and Efficacy of PRC-063 in Adults and Adolescents With ADHD

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

Summary

The purpose of this six month, open-label study is to evaluate the long-term safety and efficacy of PRC-063 in adults and adolescents with ADHD.

Detailed description

This is an open label, multicenter, 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 adolescent subjects aged ≥12 to \<18 years of age and adult subjects aged ≥18 years of age. In order to participate, subjects must have completed Purdue Pharma Study 063-009 or Purdue Pharma Study 063-010. This study will be conducted at approximately 50 centers across the United States and Canada. After giving written informed consent (as well as informed assent for subjects \<18 years of age), subjects will be screened to ascertain their suitability for the study according to the inclusion and exclusion criteria. There will be seven monthly efficacy and safety visits during which subjects will be assessed on active, open-label PRC-063. The starting dose will be at the discretion of the Investigator. Dose-adjustment visits may occur weekly to optimize the subject's dose via titration. For adolescent subjects, the maximum dose will be 85 mg/day. For adult subjects, the maximum dose will be 100 mg/day.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	Drug: PRC-063	Methylphenidate Hydrochloride Extended-Release Capsules
DRUG	PRC-063	Methylphenidate Hydrochloride Extended-Release Capsules

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2014-06-20
• Last updated: 2015-07-08

Locations

35 sites across 2 countries: United States, Canada