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Alpha-2 Agonist

Stimulant Medications for ADHD in Autism Spectrum Disorder

Phase 4
Recruiting
Led By Daniel Coury, MD
Research Sponsored by Daniel Coury
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will assess two stimulant medications and a newer type of ADHD medication to help improve medication selection and reduce repeated trials for autistic children and adolescents with ADHD.

Who is the study for?
This trial is for children and adolescents aged 4-17 with both Autism Spectrum Disorder (ASD) and ADHD. They must be able to take medication, have a consistent caregiver, and can be on stable doses of other psychotropic meds. Excluded are those who've had multiple ADHD med trials within the last year or any safety risks.
What is being tested?
The study tests two stimulant medications—methylphenidate and amphetamine—for treating ADHD in kids with autism. It also examines alpha-2 agonists' effectiveness using a SMART design to potentially streamline medication selection for this group.
What are the potential side effects?
Possible side effects from these medications may include sleep disturbances, decreased appetite, stomachaches, headaches, increased blood pressure or heart rate. Alpha-2 agonists might cause drowsiness or fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The Vanderbilt Parent Rating Scale
Secondary study objectives
Aberrant Behavior Checklist- Hyperactivity/Impulsivity subscale
Parent reported Clinical Global Impression

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Stage 1 - StimulantActive Control1 Intervention
This proposed naturalistic, pragmatic clinical trial does not involve investigational drugs. Sequential, multiple assignment randomized trial (SMART) pragmatic clinical trial. Stage 1 - randomization to either Amphetamine (AMP) or Methylphenidate (MPH). The specific medication prescribed by the physician will be determined by discussion between physician and parent / caregiver and review of the subject's insurance coverage. Subjects will receive their medication from their pharmacy.
Group II: Stage 2 - Alpha-2 Agonist or Alternate StimulantActive Control1 Intervention
Stage 2 - randomization to either Alpha-2 Agonist or other stimulant not randomized to in Stage 1: Amphetamine (AMP) or Methylphenidate (MPH). (frequency, dosage, format, and duration dependent on participant and study doctor discussion).

Find a Location

Who is running the clinical trial?

MaineHealthOTHER
74 Previous Clinical Trials
43,275 Total Patients Enrolled
University of AlbertaOTHER
942 Previous Clinical Trials
433,909 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
1,147 Patients Enrolled for Autism Spectrum Disorder
University of MichiganOTHER
1,863 Previous Clinical Trials
6,441,073 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
1,162 Patients Enrolled for Autism Spectrum Disorder
University of VirginiaOTHER
785 Previous Clinical Trials
1,315,946 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
7,077 Patients Enrolled for Autism Spectrum Disorder
Massachusetts General HospitalOTHER
3,026 Previous Clinical Trials
13,413,320 Total Patients Enrolled
42 Trials studying Autism Spectrum Disorder
2,600 Patients Enrolled for Autism Spectrum Disorder
Daniel CouryLead Sponsor
Patient-Centered Outcomes Research InstituteOTHER
580 Previous Clinical Trials
27,104,759 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
2,821 Patients Enrolled for Autism Spectrum Disorder
University of California, IrvineOTHER
566 Previous Clinical Trials
1,932,548 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
6,871 Patients Enrolled for Autism Spectrum Disorder
Holland Bloorview Kids Rehabilitation HospitalOTHER
67 Previous Clinical Trials
13,567 Total Patients Enrolled
23 Trials studying Autism Spectrum Disorder
8,361 Patients Enrolled for Autism Spectrum Disorder
Children's Hospital of PhiladelphiaOTHER
731 Previous Clinical Trials
8,472,334 Total Patients Enrolled
10 Trials studying Autism Spectrum Disorder
8,994 Patients Enrolled for Autism Spectrum Disorder

Media Library

Alpha 2 agonist (Alpha-2 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05916339 — Phase 4
Autism Spectrum Disorder Research Study Groups: Stage 1 - Stimulant, Stage 2 - Alpha-2 Agonist or Alternate Stimulant
Autism Spectrum Disorder Clinical Trial 2023: Alpha 2 agonist Highlights & Side Effects. Trial Name: NCT05916339 — Phase 4
Alpha 2 agonist (Alpha-2 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05916339 — Phase 4
~308 spots leftby Jan 2027
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