PRC-063 in Adolescent ADHD
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adolescent ADHD Patients
1 other identifier
interventional
360
2 countries
43
Brief 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 adolescents with ADHD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2014
Shorter than P25 for phase_3
43 active sites
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
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJuly 8, 2015
July 1, 2015
11 months
May 12, 2014
July 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Clinician-administered ADHD-5-Rating Scale
Baseline week 2, weeks 3-6
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo Arm
PRC-063 25 mg and Placebo
ACTIVE COMPARATORPRC-063 25 mg and placebo capsule by mouth once daily
PRC-063 45 mg and Placebo
ACTIVE COMPARATORPRC-063 45 mg and placebo capsule by mouth once daily
PRC-063 70 mg and Placebo
ACTIVE COMPARATORPRC-063 70 mg and placebo capsule by mouth once daily
PRC-063 85 mg and Placebo
ACTIVE COMPARATORPRC-063 85 mg and placebo capsule by mouth once daily
Interventions
Oral placebo capsule
Eligibility Criteria
You may qualify if:
- Must be male or non-pregnant female at least 12 years of age and less than 18 years of age.
- Must have an ADHD diagnosis, in attentive, 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.
- Female subjects must be one of the following: a. surgically sterile prior to screening; b. 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 be a negative serum β-hCG pregnancy test at screening.
- Must have a minimum level of intellectual functioning, as determined by an Intelligence Quotient (IQ) score of 80 or above based on the WASI or the KBIT.
- Mentally and physically competent to sign an informed assent document, in the case of the subject, and an informed consent document, in the case of the parent/guardian, 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 85 mg capsule.
- Total score of 24 or greater on the clinician-rated ADHA-5-RS, as assessed at Visit 2
You may not qualify if:
- 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 have 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rhodes Pharmaceuticals, L.P.lead
- Purdue Pharma LPcollaborator
Study Sites (43)
UCLA
Los Angeles, California, 90095, United States
Synergy Clinical Research
National City, California, 91950, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663, United States
Orange County Neuro Phychiatry Research Centre
Orange, California, 92868, United States
Florida Clinical Research Center
Bradenton, Florida, 34201, United States
Sarkis Clinical Research
Gainesville, Florida, 32607, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
CNS Healthcare Jacksonville
Jacksonville, Florida, 32256, United States
Florida Clinical Research Center
Maitlin, Florida, 32751, United States
Clinical Neuroscience Solutions
Orlando, Florida, 32806, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Advanced Clinical Research
Boise, Idaho, 83642, United States
Kennedy Krieger Institute
Baltimore, Maryland, 21205, United States
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, 89128, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38105, United States
FutureSearch Clinical Trials, L.P.
Austin, Texas, 78731, United States
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231, United States
Bayou City Research Ltd
Houston, Texas, 77007, United States
Red Oak Psychiatry Associates
Houston, Texas, 77090, United States
Houston Clinical Trials
Houston, Texas, 77098, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Ericksen Research
Clinton, Utah, 84015, United States
Physiciatric and Behavioral Solutions
Salt Lake City, Utah, 84105, United States
NeuroScience
Herndon, Virginia, 20170, United States
Northwest Clinical Research Center
Friday Harbor, Washington, 98007, United States
Eastside Therapeutic Resource
Kirkland, Washington, 98033, United States
Mathison Centre for Mental Health Research and Education
Calgary, Alberta, T2N 4Z6, Canada
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
Chokka Center for Integrative Health
Edmonton, Alberta, T6L 6W6, Canada
Dr. Margaret Weiss
Vancouver, British Columbia, V7V 3R8, Canada
Atlantic ADHD Centre
Dartmouth, Nova Scotia, B2Y 1H6, Canada
McMaster University
Hamilton, Ontario, Canada
Doctors Jackiewicz Professional Medical Corporation
Niagra Falls, Ontario, L2E 6A4, Canada
Dr. Judy van Stralen
Ottawa, Ontario, K2G 1W2, Canada
Stress, Trauma, Anxiety, Rehabilitation and Treatment (START) in the Mood and Anxiety Disorders Clinic
Toronto, Ontario, M5G 1N8, Canada
The Kids Clinic
Whitby, Ontario, L1N 2L1, Canada
McGill University Health Centre
Montreal, Quebec, H3Z 1P2, Canada
Royal University Hospital Saskatoon
Saskatoon, Saskatchewan, S7N OW8, Canada
Related Publications (4)
Storebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2025 Dec 4;12(12):CD009885. doi: 10.1002/14651858.CD009885.pub4.
PMID: 41342306DERIVEDStorebo OJ, Storm MRO, Pereira Ribeiro J, Skoog M, Groth C, Callesen HE, Schaug JP, Darling Rasmussen P, Huus CL, Zwi M, Kirubakaran R, Simonsen E, Gluud C. Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD009885. doi: 10.1002/14651858.CD009885.pub3.
PMID: 36971690DERIVEDWeiss MD, Surman C, Khullar A, Owens J, He E, Cataldo M, Donnelly G. Effect of a Multilayer, Extended-Release Methylphenidate Formulation (PRC-063) on Sleep in Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial Followed by a 6-Month Open-Label Follow-Up. J Child Adolesc Psychopharmacol. 2021 Nov;31(9):623-630. doi: 10.1089/cap.2021.0087. Epub 2021 Oct 28.
PMID: 34714112DERIVEDWeiss MD, Cutler AJ, Kollins SH, Donnelly GAE. Efficacy and Safety of a Long-Acting Multilayer-Release Methylphenidate Formulation (PRC-063) in the Treatment of Adolescent Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Clinical Trial with a 6-Month Open-Label Extension. J Child Adolesc Psychopharmacol. 2021 Nov;31(9):610-622. doi: 10.1089/cap.2021.0034. Epub 2021 Oct 8.
PMID: 34637343DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joseph Reiz
Purdue Pharma LP
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 15, 2014
Study Start
April 1, 2014
Primary Completion
March 1, 2015
Study Completion
May 1, 2015
Last Updated
July 8, 2015
Record last verified: 2015-07