Long-Term Safety of PRC-063 in Adolescents and Adults With ADHD

NCT02168127 | Completed Phase 3

• 1 other identifier: 063-012
• Study Type: interventional
• Target: 360
• Locations: 2 countries
• Sites: 35

Brief Summary

The purpose of this six month, open-label study is to evaluate the long-term safety and efficacy of PRC-063 in adults and adolescents with ADHD.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• occurrence of treatment-emergent adverse events

  Within 6 months

Secondary Outcomes (1)

• Clinician-administered ADHD-5-Rating Scale

  Within 6 months

Study Arms (1)

Active drug group

EXPERIMENTAL

PRC-063 - Active methylphenidate hydrochloride extended-release capsules drug group

Drug: Drug: PRC-063; Drug: PRC-063

Interventions

Drug: PRC-063 DRUG

Methylphenidate Hydrochloride Extended-Release Capsules

Also known as: Methylphenidate

Active drug group

PRC-063 DRUG

Methylphenidate Hydrochloride Extended-Release Capsules

Also known as: Methylphenidate

Active drug group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-nursing female at least 12 years of age and less than 18 years of age.
• Subjects must satisfy the following criteria to be enrolled in the study as an adult:
• Male or non-pregnant, non-nursing female at least 18 years of age and meeting the local, legal definition of adult.
• All subjects must also satisfy the following criteria to be enrolled in the study:
• Confirmation of ADHD diagnosis made at Visit 1 of Study 063-009 or 063-010 (inattentive, hyperactive/impulsive or combined-type, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition based on clinician assessment using multiple informants and a structured interview).
• Female subjects must be one of the following:
• Surgically sterile prior to screening
• Postmenopausal
• 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, as assessed at Visit 6 of Study 063-009 or 063-010 (data will not be available at the time of entry).
• If the subject is an adult, 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. If the subject is an adolescent, 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.

You may not qualify if:

• Having been diagnosed during Study 063-009 or 063-010 with 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 6 of Study 063-009 or 063-010.
• Clinically significant ECG abnormalities, as assessed at Visit 6 of Study 063-009 or 063-010 (data will not be available at the time of entry).
• Clinically significant laboratory abnormalities, as assessed at Visit 6 of Study 063-009 or 063-010 (data will not be available at the time of entry).
• 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).
• If the Investigator judges that continued treatment with PRC-063 is not in the subject's best interest.
• Subjects who are currently considered a suicide risk by the investigator.
• Having been diagnosed during Study 063-009 or 063-010 with 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.
• Having been diagnosed during Study 063-009 or 063-010 with physiological dependence (excluding nicotine) on narcotic analgesics or other psychoactive drugs (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines).
• Excessive consumption of alcohol occurring during Study 063-009 or 063-010 (consumes alcohol in quantities greater than 15 drinks per week on average; 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).
• Currently (or within 30 days before the planned start of treatment) receiving an investigational drug or using an experimental medical device, other than PRC-063.
• Homeless.

Sponsors & Collaborators

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

Study Sites (35)

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

Maitlin, Florida, 32751, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32806, 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

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

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

Friday Harbor, 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 (3)

• 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.

  PMID: 34714112 DERIVED

• 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.

  PMID: 34637343 DERIVED

• 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

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Joseph Reiz

  Purdue Pharma LP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2014
• First Posted: June 20, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

US (30); CA (5)