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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
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 belowSelect...
I can take medicine by mouth.
Select...
I am between 6 and 17 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently adjusting doses for my non-ADHD mental health medication.
Select...
I have a specific heart condition or abnormal heart test results.
Select...
My child has never had a head injury, epilepsy, or any brain function disorder.
Select...
I have not used MAOI drugs in the last 14 days.
Select...
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
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 moreOther study objectives
Change in parental stress from baseline as measured by parent report on the Family Impact Questionnaire (FIQ).
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
827 Previous Clinical Trials
6,564,347 Total Patients Enrolled
11 Trials studying Down Syndrome
1,233 Patients Enrolled for Down Syndrome
University of California, DavisOTHER
928 Previous Clinical Trials
4,720,918 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to methylphenidate or any of the ingredients in the medication, like banana.I am taking ADHD medication and cannot stop it for 3 days before the study.I am currently adjusting doses for my non-ADHD mental health medication.I have a specific heart condition or abnormal heart test results.You show signs of ADHD, such as being very active, having trouble paying attention, or showing a combination of these behaviors during the KSADS evaluation.Children who have been diagnosed with psychoses or bipolar disorder during a discussion with their parent.My child has never had a head injury, epilepsy, or any brain function disorder.I can take medicine by mouth.I have not used MAOI drugs in the last 14 days.You have been diagnosed with ADHD by a teacher or professional based on symptoms like hyperactivity or inattention.I am between 6 and 17 years old.I have severe sleep apnea according to the McGill index.
Research Study Groups:
This trial has the following groups:- Group 1: Quillivant XR
- Group 2: Placebo
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.
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