Sponsor:
Daniel Coury
Code:
NCT05916339
Conditions
ADHD
Autism Spectrum Disorder
Eligibility Criteria
Sex: All
Age: 4 - 17
Healthy Volunteers: Not accepted
Interventions
Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication
Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
Brief summary:
Conditions
ADHD
Autism Spectrum Disorder
Study ID
NCT05916339
Start date
Oct 1, 2023
Status verified date
Oct, 2025
Completion date
Dec 30, 2027
Anticipated
Primary completion date
Jan 1, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 4 - 17
Healthy Volunteers: Not accepted
Enrollment
500 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Health Services Research
Arms
active comparator: Stage 1 - Stimulant
active comparator: Stage 2 - Alpha-2 Agonist or Alternate Stimulant
Interventions
Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication
Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
Primary outcome measure
Central contacts
Locations
University of California, Irvine
Recruiting
Irvine, California, United States, 92697
Contacts
Principal Investigator:
Peter Chung, MD
Children's Hospital Los Angeles
Recruiting
Los Angeles, California, United States, 90027
Contacts
Grace Anaya
granaya@chla.usc.eduPrincipal Investigator:
Kathryn Smith, RN, MN, DrPH
Maine Medical Center
Recruiting
Portland, Maine, United States, 04102
Contacts
Principal Investigator:
Danielle Sipsock, MD
Massachusetts General Hospital Lurie Center for Autism
Recruiting
Boston, Massachusetts, United States, 02421
Contacts
Alexander Cordova
acordova1@mgh.harvard.eduPrincipal Investigator:
Ann Neumeyer, MD
University of Rochester
Recruiting
Rochester, New York, United States, 14642
Contacts
Emily Wagner
Emily_wagner@urmc.rochester.eduPrincipal Investigator:
Lynn Cole, DNP
Cincinnati Children's Hospital Medical Center
Recruiting
Cincinnati, Ohio, United States, 45229
Contacts
Courtney Herberger
Courtney.Herberger@cchmc.orgPrincipal Investigator:
Julia Anixt, MD
Nationwide Children's Hospital
Recruiting
Columbus, Ohio, United States, 43205
Contacts
Principal Investigator:
Eric Butter, PhD
Children's Hospital of Philadelphia
Recruiting
Philadelphia, Pennsylvania, United States, 19178
Contacts
Danielle Collins
collinsd2@chop.eduPrincipal Investigator:
Carlyn Glatts, MD
University of Pittsburgh
Recruiting
Pittsburgh, Pennsylvania, United States, 15262
Contacts
Principal Investigator:
Benjamin Handen
University of Virginia
Recruiting
Charlottesville, Virginia, United States, 22903
Contacts
Susie Hoffman
SRH@uvahealth.orgPrincipal Investigator:
Richard Stevenson, MD
University of Alberta, Glenrose Rehabilitation Hospital
Recruiting
Edmonton, Canada
Contacts
Principal Investigator:
Lonnie Zwaigenbaum, MD
Holland Bloorview Kids Rehabilitation Hospital
Recruiting
Toronto, Canada
Contacts
Principal Investigator:
Danielle Baribeau, MD, PhD
Sponsor
Daniel Coury
Last update posted
Oct 29, 2025
Last verified
Oct, 2025
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Daniel Coury on 2025-10-29.