Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Seeking Children Ages 6-12 with Down Syndrome for a Clinical Trial

HYP01 is a Phase 2 trial studying how guanfacine immediate-release (GIR) works to treat hyperactivity, inattention, or impulsivity in children ages 6-12 with Down syndrome. Participants will be randomly assigned to receive GIR or a placebo.

Massachusetts General Hospital Child Mental Health Down Syndrome Attention Deficit Hyperactivity Disorder
11 visits over 13 weeks
Estimated Time Commitment
Male, Female, Transgender Female, Transgender Male, Nonbinary, Intersex, Gender-expansive, 6-12 years
May Be Eligible
Payment up to $200
May Be Offered
Survey, Blood draw, Medication, Office visit
May Be Required
 
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Enrollment for this study is expected to close on Thursday, November 6, 2025

Overview

What we are studying

We are interested in learning how guanfacine immediate-release (GIR) acts in the bodies of children with Down syndrome (DS) to better understand the safest and most effective dose to treat hyperactivity, inattention, or impulsivity.


Eligible participants will be randomly assigned to receive either GIR or a placebo (looks just like the GIR study drug but does not have any drugs or medicine in it).


Why it is important

The purpose of this study is to learn more about how GIR acts in the bodies of children with DS who have hyperactivity, inattention, or impulsivity. Knowing the right dose of medicine for children is important to have the best outcome and the fewest side effects.


What we hope to accomplish

While GIR may be used off-label to treat children who have hyperactivity or attention deficit hyperactivity disorder (ADHD), the U.S. Food and Drug Administration (FDA) has not approved the use of GIR in children and adolescents with ADHD, and the best dose to use for hyperactivity in children with DS is not fully known.


Some doctors prescribe the extended-release form of guanfacine, INTUNIV®, to manage ADHD in children ages 6-17 with DS. However, INTUNIV® comes only as a pill, which must be swallowed whole, and comes in the lowest dosage strength of 1 mg.


We will use a smaller dosage strength of GIR for this study than is currently available through your pharmacy. We will use a lower dose (0.5mg) to start and may adjust the dose during the study. This may be more appropriate for determining the best dose regimen for individuals with DS. 

Principal Investigator

Michelle L Palumbo, MD

Massachusetts General Hospital

Public Profile

Project Contact

Click I Am Interested "I Am Interested" "I Am Interested" to get started. If you have questions, contact:

Lurie Center Research Team

LurieCenterResearch@mgb.org
(781) 860-1711

Who can participate


  • Age: Between the ages of 6 and 12 years old.

  • Diagnosis: Non-mosaic Down syndrome (DS).

  • Symptoms: Hyperactivity, inattention, or impulsivity.

  • Meet other eligibility criteria to be in the study.

Who cannot participate


  • Medications: Taken guanfacine (or certain other medications) in the past 14-30 days.

  • Mental health conditions: Psychiatric disorder(s) (such as major depression, bipolar disorder, obsessive-compulsive disorder, or psychosis) that require(s) medication other than guanfacine. If 8 years or older, your child might not be eligible if they have a history of suicidal thoughts or behaviors.

  • Heart conditions: Certain heart conditions, irregular heartbeats, or low heart rate/blood pressure.

  • Seizures: Recent seizures (within the past 6 months).

  • Other health conditions: Untreated severe obstructive sleep apnea (OSA), untreated thyroid disease, serious liver or kidney problems, pregnancy, or a known hypersensitivity to guanfacine.

  • Other clinical trials: Currently participating in another clinical (drug) trial or have plans to participate in another clinical trial while participating in this study.

What you may be asked to do


  • Complete questionnaires 

  • Physical exam, including vital signs

  • Electrocardiogram (ECG)

  • Blood draws 

  • Take the study drug daily for 8 weeks

  • Complete a daily diary of when your child took their medication

  • Measure your child's heart rate (HR) and blood pressure (BP) at home with a device that we will give you


Participants will complete three (3) in-person visits at the Lurie Center and eight (8) weekly check-in calls with the study team.


Project activities may include:

  • Survey
  • Blood draw
  • Medication
  • Office visit

Estimated Time Commitment

11 visits over 13 weeks

What You May Get

The study team will provide the study drug at no cost while participating in the study. After 8 weeks of taking the study drug, you will learn if your child received GIR or placebo. If you find out your child received GIR, you may choose to continue on GIR outside of the study. You can stay on the study drug for an extra 7 days while you work with your child's healthcare provider to obtain GIR outside of the study.


You may receive up to $200.00 for participating in this research study.

Location

MGH Lurie Center for Autism
1 Maguire Road, Lexington, MA 02421

Map it!


Travel

  • Parking available

Travel and Parking Details

Free parking available.

Additional Information

ClinicalTrials.gov Identifier

NCT06042257


Study Phase

Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.


Participating Institutions


Funding Source

  • NIH or Other Federal
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