ADHDPhase 3NCT03618030

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

A Phase 3 study testing PRC-063 oral capsules in people with ADHD, run by Purdue Pharma, Canada at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: ADHD
What is being tested?: PRC-063 oral capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 288 participants
Where: 8 sitesUnited States
Study dates: 21 Aug 2018to 5 Jul 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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;

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Meridien Research Inc.
Bradenton, Florida, 34201
Center for Psychiatry and Behavioral Medicine
Durham, North Carolina, 27705
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17004
South Shore Psychiatric Services
Hingham, Massachusetts, 02043
Bayou City Research
Houston, Texas, 77007
Meridien Research
Lakeland, Florida, 33805
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Meridien Research Inc.
Maitland, Florida, 32751

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Adult Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Adults With ADHD

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
Being tested: PRC-063 oral capsules, Placebo oral capsules
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRC-063 oral capsulesDrug
Daily dose
Placebo oral capsulesDrug
Daily dose

Study groups in NCT03618030
Study group	Role	What they receive
Active Treatment	Experimental	PRC-063 25, 35, 45, 55, 70, 85, or 100 mg Receives: Drug: PRC-063 oral capsules
Placebo Treatment	Placebo comparator	Matched placebo Receives: Drug: Placebo oral capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Full-day ALC - 13 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Aug 20185 Jul 2019

First posted7 Aug 2018
Study start21 Aug 2018
Primary completion5 Jul 2019
Study completion5 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ADHDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03618030
Sponsor's protocol ID: 063-020
Status last verified: Jul 2021
First submitted: 1 Aug 2018
Last updated: 26 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 34189995

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Adult Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Adults With ADHD
ClinicalTrials.gov ID: NCT03618030
Acronym / sponsor ID: 063-020
Conditions: ADHD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 288 participants (actual)
Lead sponsor: Purdue Pharma, CanadaIndustry (pharma, biotech, devices)
Study start: 21 Aug 2018 (actual)
Primary completion: 5 Jul 2019 (actual)
Study completion: 5 Jul 2019 (actual)
First posted: 7 Aug 2018 (actual)
Results: Posted 26 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active Treatment	Experimental	Drug: PRC-063 oral capsulesPRC-063 25, 35, 45, 55, 70, 85, or 100 mg
Placebo Treatment	Placebo comparator	Drug: Placebo oral capsulesMatched placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PRC-063 oral capsulesDaily dose	Drug	Active Treatment
Placebo oral capsulesDaily dose	Drug	Placebo Treatment

Primary outcome

Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit
Time frame: Full-day ALC - 13 hours
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.

Results and safety

Results posted to the registry on 26 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PRC-063 25 mg	15	3
PRC-063 35 mg	14	3
PRC-063 45 mg	21	13
PRC-063 55 mg	39	30
PRC-063 70 mg	36	29
PRC-063 85 mg	27	21
PRC-063 100 mg	18	14
Placebo Treatment	118	108

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

Time frame: Full-day ALC - 13 hours. Least squares mean (Standard Error). Unit: score on a scale

Measure	Double-Blind Active Treatment n = 116	Double-Blind Placebo Treatment n = 113
Value	302.9 (3.50)	286.6 (3.52)

Double-Blind Active Treatment vs Double-Blind Placebo Treatment: p = .0003, ANOVA

Population analysed: The full analysis (FA) population was the group of subjects who were randomized and received at least one dose of double-blind study drug, attended the full-day ALC visit evaluation, and had at least one post-dose PERMP-T evaluation during the full-day ALC visit. The primary efficacy endpoint compared all doses of PRC-063 versus Placebo.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose-Optimization	1 of 285 (0.4%)	167 of 285 (58.6%)	0 of 285
Double-Blind PRC-063 25 mg	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Double-Blind PRC-063 35 mg	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Double-Blind PRC-063 45 mg	0 of 15 (0%)	2 of 15 (13.3%)	0 of 15
Double-Blind PRC-063 55 mg	0 of 31 (0%)	3 of 31 (9.7%)	0 of 31
Double-Blind PRC-063 70 mg	0 of 30 (0%)	4 of 30 (13.3%)	0 of 30
Double-Blind PRC-063 85 mg	0 of 22 (0%)	7 of 22 (31.8%)	0 of 22
Double-Blind PRC-063 100 mg	0 of 16 (0%)	3 of 16 (18.8%)	0 of 16
Double-Blind Placebo Treatment	0 of 118 (0%)	9 of 118 (7.6%)	0 of 118

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34189995Childress 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sailaja Bhaskar, PhD study director

Purdue Pharma, Canada

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PRC-063 oral capsules in people with ADHD, run by Purdue Pharma, Canada at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit (time frame: Full-day ALC - 13 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03618030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.