Guanfacine for Hyperactivity in Down Syndrome (HYP01 Trial)

Phase 2

Recruiting

Led By Rachel Greenberg

Research Sponsored by Rachel G. Greenberg, MD, MB, MHS

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 8

Summary

This trial aims to see if guanfacine immediate release (GIR) can help reduce hyperactivity, impulsivity, and inattention in children aged 6-12 with Down syndrome after

Who is the study for?

This trial is for children aged 6-12 with Down syndrome who are hyperactive or impulsive. They must weigh at least 25 kg and have a certain level of severity in their symptoms as reported by parents and clinicians. Participants should not have taken guanfacine or strong CYP3A4 inhibitors recently.

What is being tested?

The study tests if Guanfacine Hydrochloride Immediate Release (GIR) can help manage hyperactivity/impulsivity and inattention over an 8-week period, compared to a placebo (a pill without any medicine).

What are the potential side effects?

Possible side effects of Guanfacine may include sleepiness, headache, stomach pain, nausea, and low blood pressure. Side effects vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Proportion of participants with a CGI-I (Clinical Global Impression-Improvement) score of 2 or better at Week 4

Proportion of participants with a CGI-I (Clinical Global Impression-Improvement) score of 2 or better at Week 8

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Guanfacine Hydrochloride Immediate ReleaseActive Control1 Intervention

Eligible participants will receive GIR for up to 8 weeks. The treatment period will consist of study product administration from day 0 through day 56 with a masked dose-escalation period from day 0 through day 49.

Group II: PlaceboPlacebo Group1 Intervention

Eligible participants will receive Placebo for up to 8 weeks.The treatment period will consist of study product administration from day 0 through day 56 with a masked dose-escalation period from day 0 through day 49.

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