ADHDPhase 3NCT03172481
PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD
A Phase 3 study testing PRC-063 oral capsules in people with ADHD, run by Purdue Pharma, Canada at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- PRC-063 oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 May 2017to 19 Dec 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Meridien Research Inc.
Bradenton, Florida, 34201
Bayou City Research
Houston, Texas, 77007
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Meridien Research Inc.
Maitland, Florida, 32751
Qps Mra Llc
Miami, Florida, 33143
AVIDA Inc.
Newport Beach, California, 92660
About this study
Official title: 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.
- Conditions
- ADHD
- Being tested
- PRC-063 oral capsules, Placebo oral capsules
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRC-063 oral capsulesDrug
Daily dose
Placebo oral capsulesDrug
Daily dose
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | PRC-063 25, 35, 45, 55, 70 or 85 mg Receives: Drug: PRC-063 oral capsules |
| Placebo Treatment | Placebo comparator | Not described Receives: Drug: Placebo oral capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Full-day Classroom - 13 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 May 2017
- Primary completion19 Aug 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma, Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sailaja Bhaskar, PhD, Study director, Purdue Pharma, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172481
- Sponsor's protocol ID
- 063-015
- Status last verified
- May 2019
- First submitted
- 18 May 2017
- Last updated
- 5 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33090921
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03172481
- Acronym / sponsor ID
- 063-015
- Conditions
- ADHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Purdue Pharma, CanadaIndustry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 19 Aug 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: PRC-063 oral capsulesPRC-063 25, 35, 45, 55, 70 or 85 mg |
| Placebo Treatment | Placebo comparator | Drug: Placebo oral capsules |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRC-063 oral capsulesDaily dose | Drug | Active Treatment |
| Placebo oral capsulesDaily dose | Drug | Placebo Treatment |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33090921Childress 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sailaja Bhaskar, PhD study director
Purdue Pharma, Canada
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRC-063 oral capsules in people with ADHD, run by Purdue Pharma, Canada at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-Combined Scores During the Full-Day Laboratory Classroom (time frame: Full-day Classroom - 13 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03172481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.