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Central Nervous System Stimulant

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

Phase 4

Recruiting

Led By Tanya Froehlich, 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

TEAM-DS 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.Check my eligibility

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.See study design

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.

TEAM-DS Trial 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.

TEAM-DS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

Change in parental stress from baseline as measured by parent report on the Family Impact Questionnaire (FIQ).

TEAM-DS 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,491 Total Patients Enrolled

11 Trials studying Down Syndrome

1,233 Patients Enrolled for Down Syndrome

University of California, DavisOTHER

911 Previous Clinical Trials

4,709,483 Total Patients Enrolled

2 Trials studying Down Syndrome

579 Patients Enrolled for Down Syndrome

Tanya Froehlich, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

1 Previous Clinical Trials

500 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals this research endeavor seeks to accomplish?

"This trial is designed to measure the Change from baseline in heart rate, as well as evaluate executive-functioning skills and child behaviors at Baseline, Weeks 4-5, Week 15, Week 31. To do so, a 63-item Behavior Rating Inventory of Executive Function - 2 (BRIEF-2), 58 item Aberrant Behavior Checklist - Community (ABC) and 113 item Achenbach Child Behavior Checklist (CBCL) will be employed to generate T scores for 13 sub scales with lower scores indicating better outcomes. Data collection will take place using SPSS software."

Answered by AI

To what extent have participants been recruited for this medical experiment?

"Affirmative, the particulars on clinicaltrials.gov demonstrate that this research is actively searching for participants. This investigation was initially published on October 2nd 2020 and has been most recently refreshed on October 18th 2022. 30 people are needed to be recruited from two distinct trial sites."

Answered by AI

Does this clinical trial have age restrictions and, if so, from which cohort are applicants accepted?

"As the eligibility criteria stipulates, this medical trial requires participants to be between 6 and 17 years of age."

Answered by AI

Have any other research efforts explored the efficacy of Quillivant XR?

"Quillivant XR was initially examined in 2002 by the PRODAH team at Hospital de Clínicas de Porto Alegre. Since then, 454 medical trials have been closed and 28 are currently active, many of which occur in Cincinnati, Ohio."

Answered by AI

To what demographic does eligibility for this trial apply?

"To be considered for this research, potential participants must have the qualifying condition and fall between 6-17 years old. This study is aiming to enroll a total of 30 patients."

Answered by AI

Is there still capacity for enrolment in this clinical trial?

"The clinical trial is currently accepting participants, as indicated by the listing on clinicaltrials.gov. It was initiated on October 2nd 2020 and modified 18th of October 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating Treatment of ADHD in Children With Down Syndrome

2020. "Evaluating Treatment of ADHD in Children With Down Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04219280.

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