NCT03618030

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

August 21, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2019

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

July 26, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

August 1, 2018

Results QC Date

October 29, 2020

Last Update Submit

July 2, 2021

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

  • Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit

    PERMP-T measures the number of completed and number of attempted math problems completed during a 10 minute test. The scale ranges from 0 to 800, with a higher score indicating a better outcome.

    Full-day ALC - 13 hours

Study Arms (2)

Active Treatment

EXPERIMENTAL

PRC-063 25, 35, 45, 55, 70, 85, or 100 mg

Drug: PRC-063 oral capsules

Placebo Treatment

PLACEBO COMPARATOR

Matched placebo

Drug: Placebo oral capsules

Interventions

PRC-063 oral capsulesDRUG

Daily dose

Active Treatment
Placebo oral capsulesDRUG

Daily dose

Placebo Treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males or females 18 to 60 years of age
  • Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, or licensed allied healthcare professional
  • Subject is willing and able to comply with all the protocol requirements.

You may not qualify if:

  • Primary and/or comorbid psychiatric diagnosis other than ADHD
  • Has a current or recent history of hypertension, symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug;
  • Has used any investigational drug within 30 days of the screening visit;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Meridien Research Inc.

Bradenton, Florida, 34201, United States

Location

Meridien Research

Lakeland, Florida, 33805, United States

Location

Meridien Research Inc.

Maitland, Florida, 32751, United States

Location

South Shore Psychiatric Services

Hingham, Massachusetts, 02043, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Center for Psychiatry and Behavioral Medicine

Durham, North Carolina, 27705, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17004, United States

Location

Bayou City Research

Houston, Texas, 77007, United States

Location

Related Publications (1)

  • Childress A, Cutler AJ, Marraffino AH, Bhaskar S, Donnelly G. Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Adult Laboratory Classroom Study of the Efficacy and Safety of PRC-063 (Extended-Release Methylphenidate) for the Treatment of ADHD. J Atten Disord. 2022 Apr;26(6):857-869. doi: 10.1177/10870547211025610. Epub 2021 Jun 30.

    PMID: 34189995DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Clinical Leader
Organization
Purdue Pharma L.P.
Sailaja.Bhaskar@ImbriumThera.com
1-800-733-1333

Study Officials

  • Sailaja Bhaskar, PhD

    Purdue Pharma, Canada

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 7, 2018

Study Start

August 21, 2018

Primary Completion

July 5, 2019

Study Completion

July 5, 2019

Last Updated

July 26, 2021

Results First Posted

July 26, 2021

Record last verified: 2021-07

Locations

US(8)