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

NCT02139124 | Completed Phase 3 Results

• 1 other identifier: 063-010
• Study Type: interventional
• Target: 375
• Locations: 2 countries
• Sites: 38

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 adults with ADHD

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo Arm

Drug: Placebo

PRC-063 25 mg

EXPERIMENTAL

PRC-063 25 mg

Drug: PRC-063 25 mg

PRC-063 45 mg

ACTIVE COMPARATOR

PRC-063 45 mg

Drug: PRC-063 45 mg

PRC-063 70 mg

ACTIVE COMPARATOR

PRC-063 70 mg

Drug: PRC-063 70 mg

PRC-063 100 mg

ACTIVE COMPARATOR

PRC-063 100 mg

Drug: PRC-063 100 mg

Interventions

Placebo DRUG

Oral placebo capsule

Also known as: Placebo capsule

Placebo

PRC-063 25 mg DRUG

Oral 25 mg capsule - active

Also known as: 25 mg capsule

PRC-063 25 mg

PRC-063 45 mg DRUG

Oral 45 mg capsule - active

Also known as: 45 mg capsule

PRC-063 45 mg

PRC-063 70 mg DRUG

Oral 70 mg capsule - active

Also known as: 70 mg capsule

PRC-063 70 mg

PRC-063 100 mg DRUG

Oral 100 mg capsule - active

Also known as: 100 mg capsule

PRC-063 100 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

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 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.

Sponsors & Collaborators

• Rhodes Pharmaceuticals, L.P.: lead
• Purdue Pharma, Canada: collaborator

Study Sites (38)

UCLA

Los Angeles, California, 90095, United States

Location

Synergy Clinical Research

National City, California, 91950, United States

Location

Newport Beach Clinical Research Associates, Inc.

Newport Beach, California, 92663, United States

Location

Orange County Neuro Phychiatry Research Centre

Orange, California, 92868, United States

Location

Florida Clinical Research Center

Bradenton, Florida, 34201, United States

Location

Sarkis Clinical Research

Gainesville, Florida, 32607, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

CNS Healthcare Jacksonville

Jacksonville, Florida, 32256, United States

Location

Florida Clinical Research Center

Maitland, Florida, 32751, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32806, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Advanced Clinical Research

Boise, Idaho, 83642, United States

Location

Center for Psychiatry and Behavioral Medicine Inc.

Las Vegas, Nevada, 89128, United States

Location

Princeton Medical Institute

Princeton, New Jersey, 08540, United States

Location

Medical Research Network

New York, New York, 10128, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Oregon Center for Clinical Investigation

Portland, Oregon, 92714, United States

Location

Oregon Center for Clinical Investigation

Salem, Oregon, 97301, United States

Location

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, 38105, United States

Location

FutureSearch Clinical Trials, L.P.

Austin, Texas, 78731, United States

Location

FutureSearch Trials of Dallas, L.P.

Dallas, Texas, 75231, United States

Location

Bayou City Research Ltd

Houston, Texas, 77007, United States

Location

Red Oak Psychiatry Associates

Houston, Texas, 77090, United States

Location

Houston Clinical Trials

Houston, Texas, 77098, United States

Location

Westex Clinical Investigations

Lubbock, Texas, 79423, United States

Location

Ericksen Research

Clinton, Utah, 84015, United States

Location

Physiciatric and Behavioral Solutions

Salt Lake City, Utah, 84105, United States

Location

Woodstock Research Center at Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States

Location

NeuroScience

Herndon, Virginia, 20170, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Dr. Margaret Weiss

Vancouver, British Columbia, V7V 3R8, Canada

Location

Doctors Jackiewicz Professional Medical Corporation

Niagara Falls, Ontario, L2E 6A4, Canada

Location

Dr. Judy van Stralen

Ottawa, Ontario, K2G 1W2, Canada

Location

The Kids Clinic

Whitby, Ontario, L1N 2L1, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Publications (1)

• 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.

  PMID: 34057707 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Lance Payne
• Organization: Purdue Pharma

Lance.Payne@purdue.ca

1-800-384-5349

Study Officials

• Joseph Reiz

  Purdue Pharma LP

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: October 1, 2014
• Study Completion: January 1, 2015
• Last Updated: May 7, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); US (33)