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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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).

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