ADHDPhase 3NCT02139124
The Efficacy and Safety of PRC-063 in Adult ADHD Patients
A Phase 3 study testing PRC-063 25 mg, PRC-063 45 mg and PRC-063 70 mg in people with ADHD, run by Rhodes Pharmaceuticals, L.P. at 38 sites in 2 countries.
Trial 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 adults with ADHD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHD
- What is being tested?
- PRC-063 25 mg, PRC-063 45 mg and PRC-063 70 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 38 sitesin 2 countries
- Study dates
- Apr 2014to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-nursing female at least 18 years of age and meeting the local, legal definition of adult.
- ADHD diagnosis, inattentive, hyperactive/impulsive or combined, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) based on clinician assessment using multiple informants and a structured interview.
- Unsatisfied with his or her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects naïve to pharmacological therapy for ADHD is permitted.
- Female subjects must be one of the following: a. surgically sterile prior to screening; b.
- postmenopausal; c. if of childbearing potential, abstinent or willing to use a reliable method of contraception, such as oral contraceptive, two barrier methods, a barrier method plus a spermicidal agent.
- Female subjects of Child-Bearing Potential (FOCP) must have a negative serum β-hCG pregnancy test at screening.
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- Minimum level of intellectual functioning, as determined by an Intelligence Quotient (IQ) score of 80 or above based on the WASI.
- Mentally and physically competent to sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Able and willing to comply with the study procedures for the entire length of the study, including a successful swallow test of an empty 100 mg capsule.
Who cannot join
- Having an allergy to methylphenidate or amphetamines or a history of serious adverse reactions to methylphenidate.
- Known to be non-responsive to methylphenidate treatment. Non-response is defined as methylphenidate use at various doses for a phase of at least four weeks at each dose with little or no clinical benefit.
- Being diagnosed with or having a history of strokes, epilepsy, migraine headaches (greater than 1 instance every two months), glaucoma, thyrotoxicosis, tachyarrhythmias or severe angina pectoris or serious or unstable medical illness. Subjects with controlled or stable asthma or diabetes will be permitted.
- Elevated blood pressure, defined as any values above 89 diastolic or 139 systolic, as assessed at Visit 1.
- Clinically significant ECG abnormalities, as assessed at Visit 1.
- Clinically significant laboratory abnormalities, as assessed at Visit 1.
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- Currently receiving guanethidine, pressor agents, MAO inhibitors, coumarin anticoagulants, anticonvulsants (e.g. phenobarbital, phenytoin, primidone), phenylbutazone, tricyclic antidepressants (e.g. imipramine, desipramine), selective serotonin reuptake inhibitors (SSRIs) or herbal remedies (unless on a stable dose for 4 weeks).
- Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary heart disease, transient ischemic attack or stroke or other serious cardiac problems that may place the subject at increased vulnerability to the sympathomimetic effects of a stimulant drug.
- Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
- Subjects who are currently considered a suicide risk by the investigator.
- Having a primary diagnosis of schizophrenia, schizoaffective disorder, primary affective disorder, schizotypal personality, major depression, bipolar disorder, generalized anxiety, borderline personality disorder, antisocial personality or another unstable psychiatric condition requiring treatment, as assessed by the structured interview conducted at Visit 1.
- Having a history or suspected physiological dependence (excluding nicotine) on narcotic analgesics or other psychoactive drugs (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines).
- Excessive consumption of alcohol (consumes alcohol in quantities greater than 15 drinks per week; 1 drink is defined as 360 mL/12 oz. of beer, 120 mL/4 oz. of wine, or 30 mL/1 oz. of hard liquor), or history (within previous 6 months) of alcohol abuse.
- Currently (or within 30 days before the planned start of treatment) receiving an investigational drug or using an experimental medical device.
- Homeless.
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States33 sites
FutureSearch Clinical Trials, L.P.
Austin, Texas, 78731
Northwest Clinical Research Center
Bellevue, Washington, 98007
Advanced Clinical Research
Boise, Idaho, 83642
Florida Clinical Research Center
Bradenton, Florida, 34201
University of Cincinnati
Cincinnati, Ohio, 45219
Ericksen Research
Clinton, Utah, 84015
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231
Sarkis Clinical Research
Gainesville, Florida, 32607
Sarkis Clinical Trials
Gainesville, Florida, 32607
NeuroScience
Herndon, Virginia, 20170
Bayou City Research Ltd
Houston, Texas, 77007
Red Oak Psychiatry Associates
Houston, Texas, 77090
Houston Clinical Trials
Houston, Texas, 77098
CNS Healthcare Jacksonville
Jacksonville, Florida, 32256
Eastside Therapeutic Resource
Kirkland, Washington, 98033
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128
UCLA
Los Angeles, California, 90095
Westex Clinical Investigations
Lubbock, Texas, 79423
Florida Clinical Research Center
Maitland, Florida, 32751
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38105
Synergy Clinical Research
National City, California, 91950
Medical Research Network
New York, New York, 10128
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663
IPS Research Company
Oklahoma City, Oklahoma, 73103
Orange County Neuro Phychiatry Research Centre
Orange, California, 92868
Clinical Neuroscience Solutions
Orlando, Florida, 32806
Oregon Center for Clinical Investigation
Portland, Oregon, 92714
Princeton Medical Institute
Princeton, New Jersey, 08540
Wake Research Associates
Raleigh, North Carolina, 27612
Oregon Center for Clinical Investigation
Salem, Oregon, 97301
Physiciatric and Behavioral Solutions
Salt Lake City, Utah, 84105
Stedman Clinical Trials
Tampa, Florida, 33613
Woodstock Research Center at Neuropsychiatric Associates
Woodstock, Vermont, 05091
Canada5 sites
Doctors Jackiewicz Professional Medical Corporation
Niagara Falls, Ontario, L2E 6A4
Dr. Judy van Stralen
Ottawa, Ontario, K2G 1W2
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1
Dr. Margaret Weiss
Vancouver, British Columbia, V7V 3R8
The Kids Clinic
Whitby, Ontario, L1N 2L1
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adult ADHD Patients
The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adults with ADHD
Read the detailed description
This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adult subjects (18 years of age or older) with ADHD will be randomized to PRC-063 (25, 45, 70 or 100 mg) or placebo for four weeks of double-blind evaluation of safety and efficacy. The study will have four phases: (1) screening and 1-week washout; (2)baseline and double-blind, forced-dose titration over a 2-week period; (3) double-blind evaluation over a 2-week period; and (4) a 14-day safety follow-up. Subjects will be required to visit the site 6 times over a 5 week period.
Screening and Washout: Subjects will be screened to establish eligibility for study participation. Subjects who meet eligibility requirements will undergo ADHD medication washout, if applicable.
- Conditions
- ADHD
- Being tested
- Placebo, PRC-063 25 mg, PRC-063 45 mg, PRC-063 70 mg, PRC-063 100 mg
- 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.
PlaceboDrug
Also called Placebo capsule
Oral placebo capsule
PRC-063 25 mgDrug
Also called 25 mg capsule
Oral 25 mg capsule - active
PRC-063 45 mgDrug
Also called 45 mg capsule
Oral 45 mg capsule - active
PRC-063 70 mgDrug
Also called 70 mg capsule
Oral 70 mg capsule - active
PRC-063 100 mgDrug
Also called 100 mg capsule
Oral 100 mg capsule - active
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Arm Receives: Drug: Placebo |
| PRC-063 25 mg | Experimental | PRC-063 25 mg Receives: Drug: PRC-063 25 mg |
| PRC-063 45 mg | Active comparator | PRC-063 45 mg Receives: Drug: PRC-063 45 mg |
| PRC-063 70 mg | Active comparator | PRC-063 70 mg Receives: Drug: PRC-063 70 mg |
| PRC-063 100 mg | Active comparator | PRC-063 100 mg Receives: Drug: PRC-063 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score
Participants were monitored for 4 weeks on treatment (final 2 weeks on stable dose). Clinicians rated subject behavior on the ADHD-5-Rating Scale each week. Primary outcome was based on the final week of treatment. The ADHD-5-RS is an 18-item questionnaire that measures the frequency of ADHD symptoms based on DSM-5 criteria. For each item, clinicians rate how often the behavior is displayed on a scale of 0 (Never or Rarely) to 3 (Very Often). Scores can range from 0 to 54, with lower scores indicating a lower frequency of ADHD symptoms.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionJan 2015
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 (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma, Canada
- Responsible party
- Sponsor
- Investigators
- Joseph Reiz, Study director, Purdue Pharma LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139124
- Sponsor's protocol ID
- 063-010
- Status last verified
- Apr 2019
- First submitted
- 12 May 2014
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Weiss MD, Newcorn JH, Chokka P, Cataldo M, Bhaskar S, Donnelly GAE. An Exploratory Study of Functional Outcome in Stimulant Treatment of ADHD in Adults. J Atten Disord. 2026 May 5:10870547261440452. doi: 10.1177/10870547261440452. Online ahead of print.
PubMed 42084377Weiss MD, Surman C, Khullar A, He E, Cataldo M, Donnelly G. Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension. CNS Drugs. 2021 Jun;35(6):667-679. doi: 10.1007/s40263-021-00814-z. Epub 2021 May 31.
PubMed 34057707
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adult ADHD Patients
- ClinicalTrials.gov ID
- NCT02139124
- Acronym / sponsor ID
- 063-010
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Rhodes Pharmaceuticals, L.P.Industry (pharma, biotech, devices)
- Collaborators
- Purdue Pharma, Canada
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Posted 7 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized, placebo-controlled, double-blind, parallel group study is to evaluate the clinical efficacy and safety of PRC-063 in adults with ADHD
Detailed description
This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adult subjects (18 years of age or older) with ADHD will be randomized to PRC-063 (25, 45, 70 or 100 mg) or placebo for four weeks of double-blind evaluation of safety and efficacy. The study will have four phases: (1) screening and 1-week washout; (2)baseline and double-blind, forced-dose titration over a 2-week period; (3) double-blind evaluation over a 2-week period; and (4) a 14-day safety follow-up. Subjects will be required to visit the site 6 times over a 5 week period.
Screening and Washout: Subjects will be screened to establish eligibility for study participation. Subjects who meet eligibility requirements will undergo ADHD medication washout, if applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Arm |
| PRC-063 25 mg | Experimental | Drug: PRC-063 25 mgPRC-063 25 mg |
| PRC-063 45 mg | Active comparator | Drug: PRC-063 45 mgPRC-063 45 mg |
| PRC-063 70 mg | Active comparator | Drug: PRC-063 70 mgPRC-063 70 mg |
| PRC-063 100 mg | Active comparator | Drug: PRC-063 100 mgPRC-063 100 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or non-pregnant, non-nursing female at least 18 years of age and meeting the local, legal definition of adult.
- ADHD diagnosis, inattentive, hyperactive/impulsive or combined, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) based on clinician assessment using multiple informants and a structured interview.
- Unsatisfied with his or her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects naïve to pharmacological therapy for ADHD is permitted.
- Female subjects must be one of the following: a. surgically sterile prior to screening; b.
- postmenopausal; c. if of childbearing potential, abstinent or willing to use a reliable method of contraception, such as oral contraceptive, two barrier methods, a barrier method plus a spermicidal agent.
Key exclusion criteria (15 listed)
- Having an allergy to methylphenidate or amphetamines or a history of serious adverse reactions to methylphenidate.
- Known to be non-responsive to methylphenidate treatment. Non-response is defined as methylphenidate use at various doses for a phase of at least four weeks at each dose with little or no clinical benefit.
- Being diagnosed with or having a history of strokes, epilepsy, migraine headaches (greater than 1 instance every two months), glaucoma, thyrotoxicosis, tachyarrhythmias or severe angina pectoris or serious or unstable medical illness. Subjects with controlled or stable asthma or diabetes will be permitted.
- Elevated blood pressure, defined as any values above 89 diastolic or 139 systolic, as assessed at Visit 1.
- Clinically significant ECG abnormalities, as assessed at Visit 1.
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 |
|---|---|---|
| PlaceboAlso: Placebo capsuleOral placebo capsule | Drug | Placebo |
| PRC-063 25 mgAlso: 25 mg capsuleOral 25 mg capsule - active | Drug | PRC-063 25 mg |
| PRC-063 45 mgAlso: 45 mg capsuleOral 45 mg capsule - active | Drug | PRC-063 45 mg |
| PRC-063 70 mgAlso: 70 mg capsuleOral 70 mg capsule - active | Drug | PRC-063 70 mg |
| PRC-063 100 mgAlso: 100 mg capsuleOral 100 mg capsule - active | Drug | PRC-063 100 mg |
Primary outcome
Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score
Time frame: 4 weeks
Participants were monitored for 4 weeks on treatment (final 2 weeks on stable dose). Clinicians rated subject behavior on the ADHD-5-Rating Scale each week. Primary outcome was based on the final week of treatment. The ADHD-5-RS is an 18-item questionnaire that measures the frequency of ADHD symptoms based on DSM-5 criteria. For each item, clinicians rate how often the behavior is displayed on a scale of 0 (Never or Rarely) to 3 (Very Often). Scores can range from 0 to 54, with lower scores indicating a lower frequency of ADHD symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42084377Weiss MD, Newcorn JH, Chokka P, Cataldo M, Bhaskar S, Donnelly GAE. An Exploratory Study of Functional Outcome in Stimulant Treatment of ADHD in Adults. J Atten Disord. 2026 May 5:10870547261440452. doi: 10.1177/10870547261440452. Online ahead of print.
- Derived from this study: PubMed 34057707Weiss MD, Surman C, Khullar A, He E, Cataldo M, Donnelly G. Effect of a Multi-Layer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adults with ADHD: A Randomized, Double-Blind, Forced-Dose, Placebo-Controlled Trial Followed by a 6-month Open-Label Extension. CNS Drugs. 2021 Jun;35(6):667-679. doi: 10.1007/s40263-021-00814-z. Epub 2021 May 31.
- Individual participant dataSharing planned: No
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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.
Joseph Reiz study director
Purdue Pharma LP
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRC-063 25 mg, PRC-063 45 mg and PRC-063 70 mg in people with ADHD, run by Rhodes Pharmaceuticals, L.P. at 38 sites in 2 countries.
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 9 inclusion and 15 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada. 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 7 May 2019). 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?
Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score (time frame: 4 weeks). 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 NCT02139124, which also lists 2 linked publications.
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 7 May 2019.