Status:
ACTIVE_NOT_RECRUITING
Guanfacine for Hyperactivity in Children With Down Syndrome (HYPEbeGONE_DS)
Lead Sponsor:
Rachel G. Greenberg, MD, MB, MHS
Collaborating Sponsors:
The Emmes Company, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Hyperactivity in Children With Down Syndrome
Impulsivity in Children With Down Syndrome
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine efficacy of guanfacine immediate release (GIR) for the treatment of hyperactivity/impulsivity and inattention in children 6-12 years of age with Down syndrome...
Detailed Description
This is a randomized, double-blind, placebo-controlled flexibly dosed trial of guanfacine immediate release (GIR) in children with Down syndrome (DS) and symptoms of hyperactivity, inattention, and im...
Eligibility Criteria
Inclusion
- Inclusion:
- Parent/Legal Guardian can understand the consent process and is willing to provide informed consent/HIPAA authorization prior to the conduct of any study-related procedures. When applicable, the minor participant is willing to provide assent.
- Participant has clinical diagnosis of non-mosaic DS.
- Participant is between 6 and 12 years of age (inclusive) at time of consent.
- Participant weight is ≥ 25 kg.
- Participant has clinically significant symptoms of hyperactivity, inattention and impulsivity manifested as minimum scores of the following rating scales within 30 days of randomization:
- A minimum score of 18 on the parent-reported ABC-H subscale, AND
- A minimum score of moderate or greater (≥ 4) on the clinician reported Clinical Global Impression Severity (CGI-S) score specific to hyperactivity, inattention and impulsivity behaviors.
- Participant has co-morbid medical screening and clearance to proceed with a non-stimulant medication trial with GIR within 30 days of randomization.
- Participant is willing and able to comply with study procedures, including adherence to medication dosing schedule.
- Exclusion:
- Participant has received guanfacine (any formulation) within 30 days of randomization.
- Participant has received any of the following concomitant medication classes within 30 days of randomization:
- Strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole)
- Strong CYP3A4 inducers (e.g., avasimibe, carbamazepine, phenytoin, rifampin, and St. John's wort)
- Participant has a psychiatric comorbidity, such as major depressive disorder, bipolar disorder, obsessive-compulsive disorder, or a psychotic disorder, that requires a pharmacological treatment other than guanfacine
- For participants ≥ 8 years old at the time of consent, participant has a history of suicidality or positive screen on Ask Suicide-Screening Questions (asQ) Tool.
- Participant is currently in or plans to participate in another interventional study.
- Participant has a known hypersensitivity to guanfacine.
- Participant has had a previous guanfacine treatment failure, as determined by their primary treating physician.
- Participant has had a change in another medication intended to treat symptoms of hyperactivity, inattention, and impulsivity within the last 2 weeks.
- Participant has had a seizure within the last 6 months.
- Participant has had a change in their anti-convulsant dose within the last 4 weeks.
- Participant has a cardiac-related condition including:
- Significant symptomatic bradycardia;
- 2nd degree or 3rd degree (complete) heart block;
- Baseline heart rate (HR) or systolic blood pressure (BP) \> 2 standard deviations (SD) below mean for age as determined by medical examination;
- History of aborted sudden cardiac death, unexplained syncope or near syncope, or historical use of a pacemaker as determined by medical history will require clearance by cardiology prior to enrollment;
- Known history of congenital heart disease which requires ongoing care for monitoring or management will require clearance by cardiology prior to enrollment.
- Participant has a history of untreated severe obstructive sleep apnea defined as obstructive apnea hypopnea index (OAHI) ≥ 10 events per hour or aortic regurgitation (AR). Participants with an OAHI index \> 10/hr are eligible if managed with continuous positive airway pressure (CPAP).
- Participant has untreated thyroid disease.
- Participant has a known hepatic impairment defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x the upper limit of normal (ULN) for age.
- Participant has known impending or renal failure defined as:
- Anuria diagnosed within 12 hours prior to enrollment;
- Requiring renal replacement therapy.
- Participant is pregnant.
- Participant has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study.
Exclusion
Key Trial Info
Start Date :
December 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06042257
Start Date
December 9 2024
End Date
July 1 2026
Last Update
September 2 2025
Active Locations (15)
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1
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06250
3
Emory University
Atlanta, Georgia, United States, 30322
4
Ann and Robert H. Lurie Hospital of Chicago
Chicago, Illinois, United States, 60611