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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, weeks 2-14, weeks 18, 22, 26, and 30

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].

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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.

0 / 7Eligibility criteria met