The Efficacy and Safety of PRC-063 in Adult ADHD Patients

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

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-063 100 mg

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 Type: Interventional
• Enrollment (Actual): 375
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V7V 3R8
      • Dr. Margaret Weiss
  • Ontario
    • Niagara Falls, Ontario, Canada, L2E 6A4
      • Doctors Jackiewicz Professional Medical Corporation
    • Ottawa, Ontario, Canada, K2G 1W2
      • Dr. Judy van Stralen
    • Whitby, Ontario, Canada, L1N 2L1
      • The Kids Clinic
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Diex Research Sherbrooke Inc.
• 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
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center
    • Orlando, Florida, United States, 32806
      • Clinical Neuroscience Solutions
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
  • Idaho
    • Boise, Idaho, United States, 83642
      • Advanced Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center for Psychiatry And Behavioral Medicine Inc.
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Princeton Medical Institute
  • New York
    • New York, New York, United States, 10128
      • Medical Research Network
  • North Carolina
    • 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
  • Oregon
    • Portland, Oregon, United States, 92714
      • Oregon Center for Clinical Investigation
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigation
  • 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
    • Lubbock, Texas, United States, 79423
      • Westex Clinical Investigations
  • Utah
    • Clinton, Utah, United States, 84015
      • Ericksen Research
    • Salt Lake City, Utah, United States, 84105
      • Physiciatric and Behavioral Solutions
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Woodstock Research Center at Neuropsychiatric Associates
  • Virginia
    • Herndon, Virginia, United States, 20170
      • NeuroScience
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Kirkland, Washington, United States, 98033
      • Eastside Therapeutic Resource

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.
• 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.

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 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
Experimental: PRC-063 25 mg	Drug: PRC-063 25 mg; Oral 25 mg capsule - active; Other Names: 25 mg capsule
Active Comparator: PRC-063 45 mg	Drug: PRC-063 45 mg; Oral 45 mg capsule - active; Other Names: 45 mg capsule
Active Comparator: PRC-063 70 mg	Drug: PRC-063 70 mg; Oral 70 mg capsule - active; Other Names: 70 mg capsule
Active Comparator: PRC-063 100 mg	Drug: PRC-063 100 mg; Oral 100 mg capsule - active; Other Names: 100 mg capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Weiss 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 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 (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 063-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO