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New treatment option for Down Syndrome
Official title Evaluating Treatment of ADHD in Children with Down Syndrome
ClinicalTrials.gov ID: NCT04219280
What this study is testing
What is Quillivant XR?
Quillivant XR is an investigational medicine, given as an once-weekly, being studied as a potential treatment for down syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability and ADHD.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17. Healthy volunteers may be eligible.
You may be able to join if
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, between the ages of 6.00-17.99 years at the time of consent.
- Able to take oral (liquid) medication.
- English is primary language.
- Meets criteria for ADHD (hyperactivity, inattention, or combined) on the KSADS
You likely can't join if
- Current use of ADHD stimulant or non-stimulant medication and unwilling to discontinue for \>/= 3 days prior to starting the study.
- Children with psychoses or bipolar disorder based on diagnostic interview with the parent.
- Organic Brain Injury: Children must not have a history of head trauma with loss of consciousness, epilepsy, or any other organic disorder that could...
- Specific heart conditions including the following:
- QTc on baseline ECG\>470ms or QTC \> 500 in patients with repaired CHD, as determined by ECG
- Brugada pattern, as determined by ECG
See the full eligibility criteria
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, between the ages of 6.00-17.99 years at the time of consent.
- Able to take oral (liquid) medication.
- English is primary language.
- Meets criteria for ADHD (hyperactivity, inattention, or combined) on the KSADS
- Meets criteria for ADHD (hyperactivity, inattention, or combined) on the Vanderbilt (historically or currently, as indicated by a teacher/professional)
- Current use of ADHD stimulant or non-stimulant medication and unwilling to discontinue for \>/= 3 days prior to starting the study.
- Children with psychoses or bipolar disorder based on diagnostic interview with the parent.
- Organic Brain Injury: Children must not have a history of head trauma with loss of consciousness, epilepsy, or any other organic disorder that could possibly affect brain function.
- Specific heart conditions including the following:
- QTc on baseline ECG\>470ms or QTC \> 500 in patients with repaired CHD, as determined by ECG
- Brugada pattern, as determined by ECG
- Baseline heart rate or systolic blood pressure \> 2 SD above mean for age as determined by medical examination.
- 2nd or 3rd degree AV block, as determined by ECG
- History of aborted sudden cardiac death or unexplained syncope as determined by medical history
- History of a single ventricle as determined by medical history
- Valvular regurgitation or stenosis \> mild, as determined by ECHO
- Moderate or greater ventricular dysfunction, as determined by ECHO
- Pulmonary hypertension, defined as right ventricular pressure \>33% systemic pressure or septal position consistent with \>mild right ventricular hypertension, as determined by ECHO
- Use of a pacemaker as determined by medical history
- Wolff Parkinson White/pre-ventricular excitation, as determined by ECG
- Atrial, junctional, or ventricular tachyarrhythmia, as determined by ECG
- Frequent premature ventricular contractions (PVCs) or premature atrial contractions (PACs), as determined by ECG
- Abnormal T waves with inversion in V5 and/or V6, bizarre T wave morphology, notched biphasic T waves, or ST segment depression suggesting ischemia or inflammation, as determined by ECG
- Moderate or larger atrial septal defect, as determined by ECHO
- Ventricular septal defect \> small by ECHO
- Valvar stenosis \> mild by ECHO
- Aortic root dilation \> 2SD above mean by ECHO.
- If participants meet any of the following heart conditions, they must be evaluated for the study by a cardiologist before beginning:
- Right ventricular enlargement/right axis deviation, as determined by ECG
- Intraventricular conduction delay \>120ms in child \>12 years old or \>100ms in child \<8 years old, as determined by ECG
- Right or left bundle branch block, as determined by ECG
- Treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within 14 days.
- Active titration of non-ADHD, non-MAO psychotropic medication. Stable use of non-ADHD, non-MAO psychotropic medication, defined by no dose changes for \>/= 4 weeks before starting the study medication trial, will be...
- Known hypersensitivity or allergic reactions to methylphenidate or product components such as banana (due to bananas serving as flavoring in the formulation of the project's study interventions - Quillivant XR and the...
- Severe Obstructive Sleep Apnea (OSA) as rated by McGill index of 4
- Pregnancy. (Since there is limited information regarding the safety of Quillivant XR during pregnancy, a pregnancy test will be conducted at the medical screen for female participants who have commenced the menstrual...
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Boston, Massachusetts, United States
- Cincinnati, Ohio, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Boston, Massachusetts, United States; Cincinnati, Ohio, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.