- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03172481
PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD
November 1, 2019 updated by: Purdue Pharma, Canada
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Children (6-12 Years of Age) With ADHD
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
156
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Newport Beach, California, United States, 92660
- AVIDA Inc.
-
-
Florida
-
Bradenton, Florida, United States, 34201
- Meridien Research Inc.
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Maitland, Florida, United States, 32751
- Meridien Research Inc.
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Miami, Florida, United States, 33143
- Qps Mra Llc
-
-
Nevada
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Las Vegas, Nevada, United States, 89128
- Center for Psychiatry and Behavioral Medicine
-
-
Texas
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Houston, Texas, United States, 77007
- Bayou City Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Unsatisfied with his or her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects who are naïve to pharmacological therapy for ADHD is permitted
- 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
Exclusion Criteria:
- 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
- Has untreated thyroid disease, glaucoma, Gilles de la Tourette's disorder, chronic tics or a history of seizures during the last 2 years (except simple febrile seizures), a tic disorder (exclusive of transient tic disorder). Mild medication-induced tics are not exclusionary
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Treatment
|
Daily dose
|
Experimental: Active Treatment
PRC-063 25, 35, 45, 55, 70 or 85 mg
|
Daily dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-Combined Scores During the Full-Day Laboratory Classroom
Time Frame: Full-day Classroom - 13 hrs
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sailaja Bhaskar, PhD, Purdue Pharma, Canada
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
August 19, 2017
Study Completion (Actual)
December 19, 2017
Study Registration Dates
First Submitted
May 18, 2017
First Submitted That Met QC Criteria
May 29, 2017
First Posted (Actual)
June 1, 2017
Study Record Updates
Last Update Posted (Actual)
November 5, 2019
Last Update Submitted That Met QC Criteria
November 1, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 063-015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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