TerminatedPhase 2

Guanfacine for Hyperactivity in Children With Down Syndrome (HYPEbeGONE_DS)

Stopped: Study was stopped after careful review of product manufacturing needs and available resources. Decision reflects consideration of feasibility, enrollment challenges, and overall program goals.

United States3 participantsStarted 2024-12-09

Plain-language summary

The primary 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 (DS) after 8 weeks of treatment.

Who can participate

Age range6 Years – 12 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

What they're measuring

Change in parent-rated ABC-H (Aberrant Behavior Checklist-Hyperactivity) subscale core

Timeframe: Baseline to Week 8

Trial details

NCT IDNCT06042257

SponsorRachel G. Greenberg, MD, MB, MHS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-17

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