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

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.

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Drug: Placebo; Drug: PRC-063 25 mg; Drug: PRC-063 45 mg; Drug: PRC-063 70 mg; Drug: PRC-063 85 mg

Detailed Description

This study is a randomized, phase III, multicenter, placebo-controlled, parallel-group, forced-dose titration in which adolescent subjects (12 to 17 years of age inclusive) with ADHD will be randomized to PRC-063 (25, 45, 70 or 85 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 Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
    • Calgary, Alberta, Canada, T2N 4Z6
      • Mathison Centre for Mental Health Research and Education
    • Edmonton, Alberta, Canada, T6L 6W6
      • Chokka Center for Integrative Health
  • British Columbia
    • Vancouver, British Columbia, Canada, V7V 3R8
      • Dr. Margaret Weiss
  • Nova Scotia
    • Dartmouth, Nova Scotia, Canada, B2Y 1H6
      • Atlantic ADHD Centre
  • Ontario
    • Hamilton, Ontario, Canada
      • McMaster University
    • Niagra Falls, Ontario, Canada, L2E 6A4
      • Doctors Jackiewicz Professional Medical Corporation
    • Ottawa, Ontario, Canada, K2G 1W2
      • Dr. Judy van Stralen
    • Toronto, Ontario, Canada, M5G 1N8
      • Stress, Trauma, Anxiety, Rehabilitation and Treatment (START) in the Mood and Anxiety Disorders Clinic
    • Whitby, Ontario, Canada, L1N 2L1
      • The Kids Clinic
  • Quebec
    • Montreal, Quebec, Canada, H3Z 1P2
      • McGill University Health Centre
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N OW8
      • Royal University Hospital Saskatoon
• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA
    • National City, California, United States, 91950
      • Synergy Clinical Research
    • Newport Beach, California, United States, 92663
      • Newport Beach Clinical Research Associates, Inc.
    • Orange, California, United States, 92868
      • Orange County Neuro Phychiatry Research Centre
  • Florida
    • Bradenton, Florida, United States, 34201
      • Florida Clinical Research Center
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Research
    • Jacksonville, Florida, United States, 32256
      • CNS Healthcare Jacksonville
    • Maitlin, Florida, United States, 32751
      • Florida Clinical Research Center
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
  • Idaho
    • Boise, Idaho, United States, 83642
      • Advanced Clinical Research
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Kennedy Krieger Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center for Psychiatry and Behavioral Medicine Inc.
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Clinical Neuroscience Solutions Inc.
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Clinical Trials, L.P.
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, L.P.
    • Houston, Texas, United States, 77098
      • Houston Clinical Trials
    • Houston, Texas, United States, 77090
      • Red Oak Psychiatry Associates
    • Houston, Texas, United States, 77007
      • Bayou City Research Ltd
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center at San Antonio
  • Utah
    • Clinton, Utah, United States, 84015
      • Ericksen Research
    • Salt Lake City, Utah, United States, 84105
      • Physiciatric and Behavioral Solutions
  • Virginia
    • Herndon, Virginia, United States, 20170
      • NeuroScience
  • Washington
    • Bellvue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Kirkland, Washington, United States, 98033
      • Eastside Therapeutic Resource

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.
• Must be 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. 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Arm	Drug: Placebo; Oral placebo capsule; Other Names: Placebo capsule
Active Comparator: PRC-063 25 mg and Placebo; PRC-063 25 mg and placebo capsule by mouth once daily	Drug: Placebo; Oral placebo capsule; Other Names: Placebo capsule; Drug: PRC-063 25 mg; Oral 25 mg capsule - active; Other Names: 25 mg capsule
Active Comparator: PRC-063 45 mg and Placebo; PRC-063 45 mg and placebo capsule by mouth once daily	Drug: Placebo; Oral placebo capsule; Other Names: Placebo capsule; Drug: PRC-063 45 mg; Oral 45 mg capsule - active; Other Names: 45 mg capsule
Active Comparator: PRC-063 70 mg and Placebo; PRC-063 70 mg and placebo capsule by mouth once daily	Drug: Placebo; Oral placebo capsule; Other Names: Placebo capsule; Drug: PRC-063 70 mg; Oral 70 mg capsule - active; Other Names: 70 mg capsule
Active Comparator: PRC-063 85 mg and Placebo; PRC-063 85 mg and placebo capsule by mouth once daily	Drug: Placebo; Oral placebo capsule; Other Names: Placebo capsule; Drug: PRC-063 85 mg; Oral 85 mg capsule - active; Other Names: 85 mg capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Clinician-administered ADHD-5-Rating Scale	Baseline week 2, weeks 3-6

Collaborators and Investigators

• Sponsor: Rhodes Pharmaceuticals, L.P.
• Collaborators: Purdue Pharma LP
• Investigators: Study Director: Joseph Reiz, Purdue Pharma LP

Publications and helpful links

General Publications

• Weiss 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.
• Weiss 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 7, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 063-009