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Guanfacine for Hyperactivity in Children With Down Syndrome (HYPEbeGONE_DS)

NCT06042257 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

  • Hyperactivity in Children With Down Syndrome
  • Impulsivity in Children With Down Syndrome

Interventions

DRUG

Guanfacine Hydrochloride Immediate Release

0.5 mg capsules

DRUG

Placebo

Matching placebo capsule

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Rachel G. Greenberg, MD, MB, MHS

    lead OTHER

Principal Investigators

  • Rachel Greenberg · DCRI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2025-05-17
Completion
2025-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06042257 on ClinicalTrials.gov