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PRC-063 in Adolescent ADHD

NCT02139111 · 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 randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adolescents with ADHD.

Conditions

  • ADHD

Interventions

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

Sponsors & Collaborators

  • Purdue Pharma LP

    collaborator INDUSTRY

  • Rhodes Pharmaceuticals, L.P.

    lead INDUSTRY

Principal Investigators

  • Joseph Reiz · Purdue Pharma LP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-03-31
Completion
2015-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT02139111 on ClinicalTrials.gov