AWARE: Management of ADHD in Autism Spectrum Disorder

PHASE4RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

January 1, 2027

Study Completion Date

December 30, 2027

Conditions
ADHDAutism Spectrum Disorder
Interventions
DRUG

Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication

"Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid~Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid), Ritalin, Ritalin LA, Quillichew ER, Quillivant XR (liquid)"

DRUG

Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.

"If first line stimulant therapy (Amphetamine/Methylphenidate) is deemed not effective or tolerable, re-randomization to the alternate stimulant or alpha-2 agonist will occur. If participant is satisfied with first line stimulant treatment, first-line stimulant therapy will continue.~Catapres, Clonidine, Guanfacine, Intuniv, Kapvay, Tenex"

Trial Locations (12)

14642

RECRUITING

University of Rochester, Rochester

15262

RECRUITING

University of Pittsburgh, Pittsburgh

19178

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

22903

RECRUITING

University of Virginia, Charlottesville

43205

RECRUITING

Nationwide Children's Hospital, Columbus

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

92697

RECRUITING

University of California, Irvine, Irvine

04102

RECRUITING

Maine Medical Center, Portland

02421

RECRUITING

Massachusetts General Hospital Lurie Center for Autism, Boston

Unknown

RECRUITING

University of Alberta, Glenrose Rehabilitation Hospital, Edmonton

RECRUITING

Holland Bloorview Kids Rehabilitation Hospital, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

collaborator

University of California, Irvine

OTHER

collaborator

Holland Bloorview Kids Rehabilitation Hospital

OTHER

collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

University of Rochester

OTHER

collaborator

Nationwide Children's Hospital

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

Children's Hospital Los Angeles

OTHER

collaborator

University of Virginia

OTHER

collaborator

University of Alberta

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

MaineHealth

OTHER

collaborator

University of Michigan

OTHER

lead

Daniel Coury

OTHER