- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03088267
Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study
July 8, 2019 updated by: Tris Pharma, Inc.
Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children Wit
This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine extended-release oral suspension, CII) for the treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study to assess the efficacy and safety of dose Dyanavel XR in reducing signs and symptoms of ADHD compared with placebo in pediatric subjects ages 6 to 12 years with ADHD.
Study Type
Interventional
Enrollment (Actual)
18
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
-
-
Nevada
-
Las Vegas, Nevada, United States, 89128
- Center for Psychiatry and Behavioral Medicine
-
-
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 aged 6 to 12 years at the time of screening, inclusive
- Diagnosed with ADHD by a psychiatrist within 6 months of study enrolment or newly diagnosed with ADHD using the DSM-5 criteria for ADHD
An ADHD-RS-5 score at Screening ≥90th percentile for sex and age in at least one of the following categories:
- Hyperactive-impulsive subscale,
- Inattentive subscale, or
- Total score. Subjects who do not meet this criteria at screening can have ADHD-RS-5 repeated at baseline, after washout of stimulant medication for a minimum of 24 hours prior to baseline.
- In the clinical judgment of the Investigator, the subject must be in need of pharmacological treatment for ADHD.
- Females of childbearing potential must be non-lactating and must have a negative serum pregnancy test at screening
- Provide written informed consent (parent/guardian) and assent (child aged 10 - 12 years only) prior to participation in the study
Exclusion Criteria:
- Diagnosed with any DSM-5 active disorder (other than ADHD) with the exception of specific phobias, learning disorders, motor skills disorders, communication disorders, oppositional defiant disorder, elimination disorders, and sleep disorders
- Known history of chronic medical illnesses including severe hypertension, untreated thyroid disease, peripheral vasculopathy, known structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, known family history of sudden death
- Known history or presence of significant renal or hepatic disease, as indicated by clinical laboratory assessment (liver function test results ≥ two times the upper limit of normal, blood urea nitrogen, or creatinine).
- Clinically significant abnormal ECG or cardiac findings on physical examination (including the presence of a pathologic murmur)
Use of the following medications within 30 days of Baseline Visit:
- MAOI - monoamine oxidase inhibitors (e.g., Selegiline, isocarboxazid, phenelzine, tranylcypromine)
- Tricyclic Antidepressants (e.g. Desipramine, protriptyline)
Use of the following medications within 3 days of Baseline Visit
- Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid)
- Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts)
- Use of atomoxetine within 14 days of Baseline Visit
- Planned use of prohibited drugs or agents from the Screening visit through the end of the study
- Abnormal clinically significantly laboratory test value at screening that, in the opinion of the Investigator, would preclude study participation
- Known history of allergy/hypersensitivity to amphetamine or any of the components of Dyanavel XR, or topical anaesthetics
- Known history of lack of response to amphetamine
- Parent or guardian's inability or unwillingness to follow directions of the Investigator or study research staff.
- Any uncontrolled medical condition that in the opinion of the Investigator would preclude study participation
- History of significant illness requiring hospitalization, or surgery requiring anaesthetics within 30 days of Baseline Visit
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: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active Treatment
Double blind amphetamine extended-release oral suspension, 2.5 mg/mL, 6, 7 or 8 mL po QAM
|
5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO
Other Names:
6, 7 or 8 mL PO
|
Placebo Comparator: Placebo Treatment
Double blind placebo, 6, 7 or 8 mL po QAM
|
5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO
Other Names:
6, 7 or 8 mL PO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores, Baseline to 30 Minutes Post Dose
Time Frame: Change in SKAMP-C score from baseline to 30 minutes postdose.
|
Change in SKAMP-C (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined) score from pre-dose, by treatment.
The SKAMP-C is a rating scale that assesses functional impairment related to ADHD in the classroom, including the performance of academic tasks, following class rules, and interacting with peers and adults in the classroom.
The SKAMP-C is a 13-item, 7-score rating system (0=normal to 7=maximal impairment).
The higher the score, the worse the impairment.
A decrease from baseline in the combined (all 13 items) score indicates improvement.
The SKAMP-C is used to assess the time course of treatment effects in laboratory classroom studies.
|
Change in SKAMP-C score from baseline to 30 minutes postdose.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Permanent Product Measure of Performance (PERMP-C) Score (Problems Answered Correctly)
Time Frame: 30 minutes postdose and 3 hours postdose
|
Change from pre-dose in PERMP-C scores (Permanent Product Measure of Performance; defined as the number of problems attempted and number of problems solved correctly) at 30 minutes post-dose and at 3 hours post-dose.
The PERMP-C is designed to assess compliance and academic productivity in school children.
It is a 10-minute timed test in which the number of problems attempted and correct are assessed prior to and after an intervention.
Scoring is based on problems attempted and correct.
An increase in numerical score is indicative of improvement.
|
30 minutes postdose and 3 hours postdose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sally Berry, MD, PhD, Tris Pharma
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)
February 11, 2017
Primary Completion (Actual)
February 25, 2017
Study Completion (Actual)
October 30, 2017
Study Registration Dates
First Submitted
March 9, 2017
First Submitted That Met QC Criteria
March 22, 2017
First Posted (Actual)
March 23, 2017
Study Record Updates
Last Update Posted (Actual)
July 22, 2019
Last Update Submitted That Met QC Criteria
July 8, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Amphetamine
Other Study ID Numbers
- TRI102-ADD-300
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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