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PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT03618030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2021-07-26

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 adults

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
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-21
Primary Completion
2019-07-05
Completion
2019-07-05
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 NCT03618030 on ClinicalTrials.gov