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

NCT02168127 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2015-07-08

No results posted yet for this study

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.

Conditions

  • ADHD

Interventions

DRUG

Drug: PRC-063

Methylphenidate Hydrochloride Extended-Release Capsules

DRUG

PRC-063

Methylphenidate Hydrochloride Extended-Release Capsules

Sponsors & Collaborators

  • Purdue Pharma LP

    collaborator INDUSTRY

  • Rhodes Pharmaceuticals, L.P.

    lead INDUSTRY

Principal Investigators

  • Joseph Reiz · Purdue Pharma LP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02168127 on ClinicalTrials.gov