Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study

NCT03088267 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TRI102-ADD-300
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores, Baseline to 30 Minutes Post Dose

  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 Outcomes (1)

• Change in Permanent Product Measure of Performance (PERMP-C) Score (Problems Answered Correctly)

  30 minutes postdose and 3 hours postdose

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

Double blind amphetamine extended-release oral suspension, 2.5 mg/mL, 6, 7 or 8 mL po QAM

Drug: amphetamine extended-release oral suspension, 2.5 mg/mL; Drug: Placebo extended-release oral suspension

Placebo Treatment

PLACEBO COMPARATOR

Double blind placebo, 6, 7 or 8 mL po QAM

Drug: amphetamine extended-release oral suspension, 2.5 mg/mL; Drug: Placebo extended-release oral suspension

Interventions

amphetamine extended-release oral suspension, 2.5 mg/mL DRUG

5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO

Also known as: Dyanavel XR

Active Treatment; Placebo Treatment

Placebo extended-release oral suspension DRUG

6, 7 or 8 mL PO

Active Treatment; 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tris Pharma, Inc.: lead

Study Sites (1)

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Related Publications (1)

• 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.

  PMID: 30575407 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Amphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Antonio Pardo MD
• Organization: Tris Pharma, Inc.

apardo@trispharma.com

16107502210

Study Officials

• Sally Berry, MD, PhD

  Tris Pharma

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: placebo-controlled
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, two treatment, two sequence, placebo-controlled crossover study

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 23, 2017
• Study Start: February 11, 2017
• Primary Completion: February 25, 2017
• Study Completion: October 30, 2017
• Last Updated: July 22, 2019
• Results First Posted: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)