Evaluating Treatment of ADHD in Children with Down Syndrome
Phase 4
100
about 5 years
6–17
4 sites in CA, MA, OH +1
What this study is about
This trial is testing a treatment for ADHD in children who also have Down syndrome. The goal is to see if stimulant medication helps improve symptoms and overall functioning in these children.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Placebo
- 2.Take Quillivant XR
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: 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 ]
Secondary: 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]., Mean magnitude of change in Diastolic Blood Pressure (DBP) compared to participants' pre-trial baseline, on maximum dosage of MPH received during the MPH titration trial [Phase 1] and during the optimal MPH dosage maintenance period [Phase 4]., Mean magnitude of change in Heart Rate (HR) compared to participants' pre-trial baseline, on maximum dosage of MPH received during the MPH titration trial [Phase 1] and during the optimal MPH dosage maintenance period [Phase 4]., Mean magnitude of change in Systolic Blood Pressure (SBP) compared to participants' pre-trial baseline, on maximum dosage of MPH received during the MPH titration trial [Phase 1] and during the optimal MPH dosage maintenance period [Phase 4].
Peds, Psychiatry / Mental Health