CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Guanfacine Extended Release +1 moredrug
Likely dose
Guanfacine Extended Release 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05657860
NCT05657860Phase 4Completed
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A Double Blind, Placebo Controlled, Fixed-Flexible Dose Clinical Trial of Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome

Maimonides Medical Center·interventional·Posted Dec 20, 2022·Updated Aug 19, 2024

In Brief

A Phase 4 clinical trial evaluating Guanfacine Extended Release and Placebo for Prader-Willi Syndrome and 20 related conditions. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This is a placebo-controlled clinical trial to assess whether Guanfacine Extended Release (GXR) reduces aggression and self injurious behavior in individuals with Prader Willi Syndrome (PWS). In addition, the study will establish the safety of GXR with a specific focus on metabolic effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrader-Willi Syndrome, Aggression, Self-Injurious Behavior, Pathologic Processes, Behavioral Symptoms, Intellectual Disability, Neurobehavioral Manifestations, Neurologic Manifestations, Nervous System Diseases, Abnormalities, Multiple, Congenital Abnormalities, Chromosome Disorders, Genetic Diseases, Inborn, Obesity, Overnutrition, Nutrition Disorders, Antihypertensive Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, Skin-Picking
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedDec 20, 2022
Enrollment StartDec 17, 2020
Primary CompletionDec 16, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 3.5 years ago

Interventions

Guanfacine Extended Releasedrug

Initial dose for all participants will be 1mg per day. If the medication is well tolerated, the dose can be raised to 2 mg until day 28 and increased to 3 mg for the remaining 4 weeks in the trial. The dose schedule will not be fixed., the treating clinician can delay a planned increase or lower the dose to manage adverse effects. At week 8 timepoint, the study will be unblinded.and subjects will continue treatment for 8 weeks.

Placeboother

Placebo will be administered concurrently with GXR during trials.