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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
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
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
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
43,473 Total Patients Enrolled
University of AlbertaOTHER
913 Previous Clinical Trials
389,933 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
1,147 Patients Enrolled for Autism Spectrum Disorder
University of MichiganOTHER
1,833 Previous Clinical Trials
6,422,628 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
1,162 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried more than one ADHD medication in the last year.I have no health issues that would make it unsafe for me to take the study medications.I have been on a stable dose of my mental health medication for over 4 weeks.I am between 4 and 17 years old.I have someone who regularly spends time with my child and can report on their condition.I can take medication consistently, whether it's a pill, liquid, or mixed with food.I have been diagnosed with ADHD according to DSM-5.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1 - Stimulant
- Group 2: Stage 2 - Alpha-2 Agonist or Alternate Stimulant
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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