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PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD

NCT03172481 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2019-11-05

Study results available
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Summary

This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric subjects between 6 to 12 years of age.

Conditions

  • ADHD

Interventions

DRUG

PRC-063 oral capsules

Daily dose

DRUG

Placebo oral capsules

Daily dose

Sponsors & Collaborators

  • Purdue Pharma, Canada

    lead INDUSTRY

Principal Investigators

  • Sailaja Bhaskar, PhD · Purdue Pharma, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2017-08-19
Completion
2017-12-19
FDA Drug
Yes

Countries

  • United States

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 NCT03172481 on ClinicalTrials.gov