PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD

NCT03172481 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 063-015
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 6

Brief Summary

This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric subjects between 6 to 12 years of age.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-Combined Scores During the Full-Day Laboratory Classroom

  The SKAMP rating scale is a validated tool that assesses behavioral symptoms of ADHD in a classroom setting. The SKAMP-C comprises 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13), and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0 = none, 6 = maximal impairment), for a total possible combined score of 0 to 78 (lower score indicated fewer ADHD symptoms). During the Full-day Classroom visit, SKAMP-C was assessed at pre-dose and approximately 1, 2, 4, 6, 8, 10, 12, and 13 hours post-dose. Average post-dose score and change from pre-dose score were analyzed on the individual SKAMP-C scores.

  Full-day Classroom - 13 hrs

Study Arms (2)

Active Treatment

EXPERIMENTAL

PRC-063 25, 35, 45, 55, 70 or 85 mg

Drug: PRC-063 oral capsules

Placebo Treatment

PLACEBO COMPARATOR

Drug: Placebo oral capsules

Interventions

PRC-063 oral capsules DRUG

Daily dose

Active Treatment

Placebo oral capsules DRUG

Daily dose

Placebo Treatment

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females greater than or equal to 6 and less than or equal to 12 years of age
• Females who are non-pregnant and non-nursing
• Females of child-bearing potential who agree to practice a clinically accepted method of contraception during the study and for at least one month prior to study dosing and one month following completion of the study. Acceptable contraceptive methods include abstinence, oral contraception, surgical sterilization (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), intrauterine device, or diaphragm in addition to spermicidal foam and condom on male partner, or systemic contraception (e.g. levonorgestrel-releasing implant)
• Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, developmental pediatrician or licensed allied healthcare professional using the DSM-5 and confirmed by administration of a structured diagnostic interview using the K-SADS-PL
• Ratings on the ADHD-RS-5 based on when the subject is not receiving treatment for ADHD, the subject must have ≥ 90th percentile normative value for gender and age in at least 1 of the categories: total score, inattentive subscale or hyperactive/impulse subscale
• Must be functioning at an age-appropriate level intellectually as determined by an intelligence quotient of ≥ 80 on a documented IQ assessment such as the WASI-II vocabulary and matrix reasoning components, or the KBIT-2
• Must have the ability to complete the PERMP assessments
• Have parental consent (signed informed consent form) and written or verbal assent from the subject
• Subject and parent(s)/caregiver are willing and able to comply with all the protocol requirements and parent(s) or caregiver must be able to provide transportation for the subject to and from the analog classroom sessions

You may not qualify if:

• Has blood pressure and pulse greater than the 95th percentile for age and gender
• Has current or recent history (within the past 6 months) of drug abuse or dependence disorder in the subject or the immediate family or by someone living at the participant's' home or positive urine drug screen for stimulant medication (other than currently prescribed stimulant for the treatment of ADHD) or drugs of abuse at the screening visit
• Primary and/or comorbid psychiatric diagnosis other than ADHD with the exception of simple phobias, motor skill disorders, communication disorders, learning disorders and adjustment disorders so long as such disorder is judged not to interfere with study participation or the safety of the subject or other participants. Children meeting conduct disorder or oppositional defiant disorder criteria but without history of prominent aggressive outbursts that could interfere with study participation or the safety of the subject or other participants will be allowed to enroll at the discretion of the investigator
• Subjects with a family history (first degree relatives) of sudden cardiac death require review and approval by the medical monitor for participation in the study
• Has a current or recent history of hypertension, symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug
• Has a concurrent medical condition that, in the opinion of the investigator, could cause participation in this study to be detrimental to the subject
• Has used any investigational drug within 30 days of the screening visit
• Has a known history of physical, sexual, or emotional abuse in the last year
• Has a medical history of hepatitis A, B, C or human immunodeficiency virus, or tests positive for any of these at screening
• Has a positive urine pregnancy test (if applicable) at screening
• Has positive findings on C-SSRS for suicidal ideation or behaviors at screening.

Sponsors & Collaborators

• Purdue Pharma, Canada: lead

Study Sites (6)

AVIDA Inc.

Newport Beach, California, 92660, United States

Location

Meridien Research Inc.

Bradenton, Florida, 34201, United States

Location

Meridien Research Inc.

Maitland, Florida, 32751, United States

Location

Qps Mra Llc

Miami, Florida, 33143, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Bayou City Research

Houston, Texas, 77007, United States

Location

Related Publications (1)

• Childress AC, Brams MN, Cutler AJ, Donnelly GAE, Bhaskar S. Efficacy and Safety of Multilayer, Extended-Release Methylphenidate (PRC-063) in Children 6-12 Years of Age with Attention-Deficit/Hyperactivity Disorder: A Laboratory Classroom Study. J Child Adolesc Psychopharmacol. 2020 Dec;30(10):580-589. doi: 10.1089/cap.2020.0109. Epub 2020 Oct 22.

  PMID: 33090921 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: Clinical Leader
• Organization: Purdue Pharma L.P.

steven.ripa@pharma.com

1-800-733-1333

Study Officials

• Sailaja Bhaskar, PhD

  Purdue Pharma, Canada

  STUDY DIRECTOR

Publication Agreements

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

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 18, 2017
• First Posted: June 1, 2017
• Study Start: May 1, 2017
• Primary Completion: August 19, 2017
• Study Completion: December 19, 2017
• Last Updated: November 5, 2019
• Results First Posted: June 4, 2019

Record last verified: 2019-05

Locations

US (6)