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Central Nervous System Stimulant
Methylphenidate for ADHD (AMPAIII Trial)
Phase 4
Recruiting
Led By Stewart H Mostofsky, MD
Research Sponsored by Donald Gilbert, MD, MS, FAAN, FAAP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently between 8 years 0 months and 12 years, 11 months, 30 days
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up less than one month
Awards & highlights
AMPAIII Trial Summary
This trial is testing whether two measures of brain function can be used to help guide treatment for attention-deficit/hyperactivity disorder (ADHD).
Who is the study for?
This trial is for right-handed children aged 8-12 years with ADHD, who are willing to suspend stimulant medications if prescribed. Healthy controls without ADHD or other disorders can also join. It excludes those on certain medications, with onset of menses, pregnancy, or serious neurological conditions.Check my eligibility
What is being tested?
The study tests the effects of Methylphenidate (a common ADHD medication) against a placebo in improving brain function measures obtained by Transcranial Magnetic Stimulation (TMS). The goal is to refine treatment precision for ADHD in children.See study design
What are the potential side effects?
Methylphenidate may cause side effects like nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, and possibly increased heart rate and blood pressure.
AMPAIII Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 8 and 12 years old.
AMPAIII Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ less than one month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~less than one month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Transcranial Magnetic Stimulation (TMS)-evoked Short Interval Cortical Inhibition (SICI) Test-Retest Reliability
Transcranial Magnetic Stimulation (TMS)-evoked Task Related Up Modulation (TRUM) Test-Retest Reliability
Side effects data
From 2020 Phase 4 trial • 267 Patients • NCT0203990851%
Appetite Loss
40%
Insomnia
33%
Irritability
29%
Picking at skin, nailbiting
21%
Worried/Anxious
21%
Dull, tired, listless
19%
Tearful, depressed
18%
Stomachache
13%
Headache
13%
Motor Tics
12%
Buccal-lingual movements
10%
Social Withdrawal
1%
Hospitalized
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1-Medication First
Phase 1 - Placebo First
Phase 2 - 7-Day Dosing
Phase 2 - 5-Day Dosing
AMPAIII Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Attention Deficit Hyperactivity Disorder (ADHD)Experimental Treatment2 Interventions
8 to 12 year old children diagnosed with ADHD. Randomized, blinded, single dose, placebo controlled, crossover trial.
Group II: Typically developing controls (TDC)Active Control1 Intervention
Typically developing controls - 8 to 12 year old children
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
FDA approved
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.OTHER
88 Previous Clinical Trials
24,724 Total Patients Enrolled
5 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
4,554 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Donald Gilbert, MD, MS, FAAN, FAAPLead Sponsor
Stewart H Mostofsky, MDPrincipal InvestigatorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and agree to the study's terms.I am between 8 and 12 years old.I have been diagnosed with a speech/language disorder or reading disability.My gender, race, or background does not limit my participation.You do not have ADHD or other developmental or psychiatric disorders based on specific criteria and assessments.I have been diagnosed with ADHD and may have Oppositional Defiant Disorder, but not Conduct Disorder.My child with ADHD is willing to try a study medication for research.You have a device implanted in your body, such as a brain stimulator or pacemaker.I am willing to discuss my ADHD or related conditions.I am currently taking medication for depression, ADHD, or mood stabilization.I am a female and have started menstruating or am pregnant.You have been diagnosed with conditions like mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious neurological disorders.You use your right hand the most.You have been diagnosed with major depression, bipolar disorder, conduct disorder, adjustment disorder, other anxiety disorders, or other developmental psychiatric conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Deficit Hyperactivity Disorder (ADHD)
- Group 2: Typically developing controls (TDC)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT04421248 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are eligible to join this research initiative?
"Affirmative. The clinical trial, which was created on September 1st 2020 and updated last on June 10th 2022, is actively searching for 214 patients across 2 sites as indicated by the data hosted on clinicaltrials.gov."
Answered by AI
Does the criteria for this investigation include individuals under 30 years of age?
"According to the criteria for enrollment, only individuals aged 8-12 are eligible. This particular study has 73 participants under 18 years old and 31 above 65 years of age."
Answered by AI
Is the enrollment phase of this experiment currently open?
"Correct. Clinicaltrials.gov suggests that this trial was first posted on September 1st 2020 and is currently in search of 214 participants from two sites, with the most recent update occuring June 10th 2022."
Answered by AI
What are the associated risks of administering Methylphenidate to patients?
"Given the fact that this is a Phase 4 trial, which indicates approval of Methylphenidate for use, our team here at Power determined its safety with a score of 3."
Answered by AI
Does my profile satisfy the requirements for participation in this trial?
"This clinical research is targeting 214 children with a diagnosis of Attention Deficit Hyperactivity Disorder between the ages of 8 and 12. To qualify for enrollment, participants must meet these criteria."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
North Carolina
What site did they apply to?
Kennedy Krieger Institute
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Money a d help with my adhd.
PatientReceived 2+ prior treatments
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