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Alpha-2 Adrenergic Agonist
Guanfacine Hydrochloride Immediate Release for Hyperactivity in Children (HYP01 Trial)
Phase 2
Waitlist Available
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
Awards & highlights
HYP01 Trial 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.Check my eligibility
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).See study design
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.
HYP01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
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 moreHYP01 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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Who is running the clinical trial?
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,431 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,967 Previous Clinical Trials
2,672,837 Total Patients Enrolled
Rachel G. Greenberg, MD, MB, MHSLead Sponsor
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many different sites is this research study being conducted?
"Duke University Hospital in Durham, Ann and Robert H. Lurie Hospital of Chicago in Chicago, the University of Iowa in Iowa City, alongside 13 additional sites are actively enrolling participants for this medical investigation."
Answered by AI
Is the study open to individuals older than 85 years?
"Potential participants must be between 6 and 12 years old to qualify for inclusion in this research study."
Answered by AI
What are the safety considerations associated with Guanfacine Hydrochloride Immediate Release for individuals?
"Based on the Phase 2 trial status, our team at Power rates Guanfacine Hydrochloride Immediate Release with a safety score of 2."
Answered by AI
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