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Central Nervous System Stimulant

Quillivant XR for ADHD in Down Syndrome (TEAM-DS Trial)

Phase 4
Recruiting
Led By Kathleen Angkustsiri, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to take oral (liquid) medication
Male or female, between the ages of 6.00-17.99 years at the time of consent
Must not have
Active titration of non-ADHD, non-MAO psychotropic medication
Specific heart conditions including the following: QTc on baseline ECG>470ms or QTC > 500 in patients with repaired CHD, Brugada pattern, Baseline heart rate or systolic blood pressure > 2 SD above mean for age, 2nd or 3rd degree AV block, History of aborted sudden cardiac death or unexplained syncope, History of a single ventricle, Valvular regurgitation or stenosis > mild, Moderate or greater ventricular dysfunction, Pulmonary hypertension, Use of a pacemaker, Wolff Parkinson White/pre-ventricular excitation, Atrial, junctional, or ventricular tachyarrhythmia, Frequent premature ventricular contractions (PVCs) or premature atrial contractions (PACs), Abnormal T waves with inversion in V5 and/or V6, Moderate or larger atrial septal defect, Ventricular septal defect > small, Valvar stenosis > mild, Aortic root dilation > 2SD above mean
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 2-14, weeks 18, 22, 26, and 30
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will help determine the feasibility and effectiveness of stimulant medication for treating ADHD in children with Down syndrome.

Who is the study for?
This trial is for children aged 6 to 17 with Down syndrome and ADHD who can take oral medication, speak English, and meet specific ADHD criteria. They must be willing to follow the study plan and not have brain injuries, severe sleep apnea, certain heart conditions, or be on current ADHD meds they can't stop.
What is being tested?
The trial tests Quillivant XR (a stimulant medication) against a placebo in children with Down syndrome who also have ADHD. It's designed to see if this medicine is safe and works well over both short and long terms compared to no active treatment.
What are the potential side effects?
Quillivant XR may cause side effects like decreased appetite, insomnia, stomach pain, nausea, vomiting, increased heart rate or blood pressure. Side effects vary from child to child.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take medicine by mouth.
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I am between 6 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently adjusting doses for my non-ADHD mental health medication.
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I have a specific heart condition or abnormal heart test results.
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My child has never had a head injury, epilepsy, or any brain function disorder.
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I have not used MAOI drugs in the last 14 days.
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I have severe sleep apnea according to the McGill index.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 2-14, weeks 18, 22, 26, and 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 2-14, weeks 18, 22, 26, and 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean magnitude of change in ADHD Symptoms as measured by parent and teacher report on the Vanderbilt ADHD Parent and Teacher Rating Scales, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
Mean magnitude of change in Emotion Regulation as measured by parent and teacher report on the BRIEF2, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]
Secondary study objectives
Frequency of clinically significant cardiac occurrences on MPH- clinically significant changes for Blood Pressure (BP) during the MPH titration trial [Phase 1] and the MPH dosage maintenance period [Phase 4].
Frequency of clinically significant cardiac occurrences on MPH- clinically significant changes for Heart Rate (HR) during the MPH titration trial [Phase 1] and the MPH dosage maintenance period [Phase 4].
Frequency of clinically significant physician-collected cardiac occurrences on MPH - clinically significant change from baseline in ECG findings during the during the MPH titration trial [Phase 1] and the optimal MPH dosage maintenance period [Phase 4].
+6 more
Other study objectives
Change in parental stress from baseline as measured by parent report on the Family Impact Questionnaire (FIQ).

Awards & Highlights

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.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Quillivant XRActive Control1 Intervention
Once-daily, long-lasting MPH solution with the following dosing schedules: 7.5mg/15mg/22.5mg/30mg for children 20-25kg 10mg/20mg/30mg/40mg for children 26-30kg 10mg/22mg/34mg/46mg for children \> 30 mg
Group II: PlaceboPlacebo Group1 Intervention
Liquid-based suspension to match the color and banana-flavor of Quillivant XR.

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,517 Total Patients Enrolled
11 Trials studying Down Syndrome
1,233 Patients Enrolled for Down Syndrome
University of California, DavisOTHER
946 Previous Clinical Trials
4,756,060 Total Patients Enrolled
2 Trials studying Down Syndrome
579 Patients Enrolled for Down Syndrome
Kathleen Angkustsiri, MDPrincipal InvestigatorUniversity of California Davis MIND Institute
2 Previous Clinical Trials
68 Total Patients Enrolled

Media Library

Quillivant XR (Central Nervous System Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT04219280 — Phase 4
Down Syndrome Research Study Groups: Quillivant XR, Placebo
Down Syndrome Clinical Trial 2023: Quillivant XR Highlights & Side Effects. Trial Name: NCT04219280 — Phase 4
Quillivant XR (Central Nervous System Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04219280 — Phase 4
~15 spots leftby Sep 2025