Clinical trial NCT03088267: Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study
Official title: Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children Wit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-23
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Males or females aged 6 to 12 years at the time of screening, inclusive
2. Diagnosed with ADHD by a psychiatrist within 6 months of study enrolment or newly diagnosed with ADHD using the DSM-5 criteria for ADHD
3. An ADHD-RS-5 score at Screening ≥90th percentile for sex and age in at least one of the following categories:

   1. Hyperactive-impulsive subscale,
   2. Inattentive subscale, or
   3. 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.
4. In the clinical judgment of the Investigator, the subject must be in need of pharmacological treatment for ADHD.
5. Females of childbearing potential must be non-lactating and must have a negative serum pregnancy test at screening
6. Provide written informed consent (parent/guardian) and assent (child aged 10 - 12 years only) prior to participation in the study

Exclusion Criteria:

1. 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
2. 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
3. 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).
4. Clinically significant abnormal ECG or cardiac findings on physical examination (including the presence of a pathologic murmur)
5. 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)
6. 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)
7. Use of atomoxetine within 14 days of Baseline Visit
8. Planned use of prohibited drugs or agents from the Screening visit through the end of the study
9. Abnormal clinically significantly laboratory test value at screening that, in the opinion of the Investigator, would preclude study participation
10. Known history of allergy/hypersensitivity to amphetamine or any of the components of Dyanavel XR, or topical anaesthetics
11. Known history of lack of response to amphetamine
12. Parent or guardian's inability or unwillingness to follow directions of the Investigator or study research staff.
13. Any uncontrolled medical condition that in the opinion of the Investigator would preclude study participation
14. History of significant illness requiring hospitalization, or surgery requiring anaesthetics within 30 days of Baseline Visit

Primary outcomes:
measure: Change in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores, Baseline to 30 Minutes Post Dose
timeFrame: Change in SKAMP-C score from baseline to 30 minutes postdose.
Secondary outcomes:
measure: Change in Permanent Product Measure of Performance (PERMP-C) Score (Problems Answered Correctly)
timeFrame: 30 minutes postdose and 3 hours postdose
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine
state: Nevada
Study officials:
affiliation: Tris Pharma
name: Sally Berry, MD, PhD
role: STUDY_CHAIR
References:
citation: Childress AC, Kando JC, King TR, Pardo A, Herman BK. Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension in the Treatment of Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2019 Feb;29(1):2-8. doi: 10.1089/cap.2018.0078. Epub 2018 Dec 21.