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Outcome Measures

Primary Outcomes (1)

Change in parent-rated ABC-H (Aberrant Behavior Checklist-Hyperactivity) subscale core
Change from baseline to Week 8 of the ABC-H subscale score. The ABC-H is a subscale of the ABC. Each of the 16 items is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), or 3 (severe problem). The total score range is 0 to 48, where a higher score indicates endorsement of greater hyperactivity. Rating based on patient's behavior in last 4 weeks.
Baseline to Week 8

Secondary Outcomes (4)

Change in parent-rated ABC-H (Aberrant Behavior Checklist-Hyperactivity) subscale core
Baseline to Week 4
Proportion of participants with a CGI-I (Clinical Global Impression-Improvement) score of 2 or better at Week 4
Baseline to Week 4
Proportion of participants with a CGI-I (Clinical Global Impression-Improvement) score of 2 or better at Week 8
Baseline to Week 8
Safety of GIR (guanfacine immediate release)
Baseline through Week 8

Study Arms (2)

Guanfacine Hydrochloride Immediate Release

ACTIVE COMPARATOR

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.

Drug: Guanfacine Hydrochloride Immediate Release

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Eligibility Criteria

Age6 Years - 12 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

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.

Study Sites (14)

Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States

Emory University

Atlanta, Georgia, 30322, United States

Ann and Robert H. Lurie Hospital of Chicago

Chicago, Illinois, 60611, United States

University of Iowa

Iowa City, Iowa, 52242, United States

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Massachusetts General Hospital

Lexington, Massachusetts, 02421, United States

MeSH Terms

Conditions

SpasmImpulsive Behavior

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetates

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

TRIPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR

Masking Details

A masked investigational pharmacist or designee will dispense study product according to randomization treatment assignments. All other site staff as well as participants and parents/legal guardians will also be masked for up to 8 weeks while the study participant is receiving study product. Participants, parents/legal guardians, site staff, and study administrators will be unmasked at the 8 week study visit. Emergency unmasking may occur at any time throughout the study in the event that knowledge of the actual treatment is absolutely essential for further management of the participant.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Participants will be randomized 2:1 to GIR or placebo.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Associate Professor of Pediatrics

Study Stopped

Guanfacine for Hyperactivity in Children With Down Syndrome (HYPEbeGONE_DS)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Guanfacine Hydrochloride Immediate Release

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Guanfacine for Hyperactivity in Children With Down Syndrome (HYPEbeGONE_DS)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Guanfacine Hydrochloride Immediate Release

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations