PRC-063 in Adolescent ADHD

NCT ID: NCT02139111

Last Updated: 2015-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-05-31

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.

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo Arm

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo capsule

PRC-063 25 mg and Placebo

PRC-063 25 mg and placebo capsule by mouth once daily

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo capsule

PRC-063 25 mg

Intervention Type: DRUG

Oral 25 mg capsule - active

PRC-063 45 mg and Placebo

PRC-063 45 mg and placebo capsule by mouth once daily

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo capsule

PRC-063 45 mg

Intervention Type: DRUG

Oral 45 mg capsule - active

PRC-063 70 mg and Placebo

PRC-063 70 mg and placebo capsule by mouth once daily

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo capsule

PRC-063 70 mg

Intervention Type: DRUG

Oral 70 mg capsule - active

PRC-063 85 mg and Placebo

PRC-063 85 mg and placebo capsule by mouth once daily

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo capsule

PRC-063 85 mg

Intervention Type: DRUG

Oral 85 mg capsule - active

Interventions

Placebo

Oral placebo capsule

Intervention Type: DRUG

PRC-063 25 mg

Oral 25 mg capsule - active

Intervention Type: DRUG

PRC-063 45 mg

Oral 45 mg capsule - active

Intervention Type: DRUG

PRC-063 70 mg

Oral 70 mg capsule - active

Intervention Type: DRUG

PRC-063 85 mg

Oral 85 mg capsule - active

Intervention Type: DRUG

Other Intervention Names

Placebo capsule; 25 mg capsule; 45 mg capsule; 70 mg capsule; 85 mg capsule

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: collaborator

Rhodes Pharmaceuticals, L.P.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Reiz

Role: STUDY_DIRECTOR

Purdue Pharma LP

Locations

UCLA

Los Angeles, California, United States

Synergy Clinical Research

National City, California, United States

Newport Beach Clinical Research Associates, Inc.

Newport Beach, California, United States

Orange County Neuro Phychiatry Research Centre

Orange, California, United States

Florida Clinical Research Center

Bradenton, Florida, United States

Sarkis Clinical Research

Gainesville, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

CNS Healthcare Jacksonville

Jacksonville, Florida, United States

Florida Clinical Research Center

Maitlin, Florida, United States

Clinical Neuroscience Solutions

Orlando, Florida, United States

Miami Research Associates

South Miami, Florida, United States

Stedman Clinical Trials

Tampa, Florida, United States

Advanced Clinical Research

Boise, Idaho, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

Center for Psychiatry and Behavioral Medicine Inc.

Las Vegas, Nevada, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, United States

FutureSearch Clinical Trials, L.P.

Austin, Texas, United States

FutureSearch Trials of Dallas, L.P.

Dallas, Texas, United States

Bayou City Research Ltd

Houston, Texas, United States

Red Oak Psychiatry Associates

Houston, Texas, United States

Houston Clinical Trials

Houston, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Ericksen Research

Clinton, Utah, United States

Physiciatric and Behavioral Solutions

Salt Lake City, Utah, United States

NeuroScience

Herndon, Virginia, United States

Northwest Clinical Research Center

Friday Harbor, Washington, United States

Eastside Therapeutic Resource

Kirkland, Washington, United States

Mathison Centre for Mental Health Research and Education

Calgary, Alberta, Canada

University of Calgary

Calgary, Alberta, Canada

Chokka Center for Integrative Health

Edmonton, Alberta, Canada

Dr. Margaret Weiss

Vancouver, British Columbia, Canada

Atlantic ADHD Centre

Dartmouth, Nova Scotia, Canada

McMaster University

Hamilton, Ontario, Canada

Doctors Jackiewicz Professional Medical Corporation

Niagra Falls, Ontario, Canada

Dr. Judy van Stralen

Ottawa, Ontario, Canada

Stress, Trauma, Anxiety, Rehabilitation and Treatment (START) in the Mood and Anxiety Disorders Clinic

Toronto, Ontario, Canada

The Kids Clinic

Whitby, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Royal University Hospital Saskatoon

Saskatoon, Saskatchewan, Canada

Countries

United States; Canada

References

Storebo 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.

Reference Type: DERIVED

PMID: 36971690 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34714112 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34637343 (View on PubMed)

Other Identifiers

063-009

Identifier Type: -

Identifier Source: org_study_id