Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome

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.

Conditions

• Prader-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

Interventions

DRUG

Guanfacine Extended Release

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.

OTHER

Placebo

Placebo will be administered concurrently with GXR during trials.

Sponsors & Collaborators

• Maimonides Medical Center

  lead OTHER

Principal Investigators

• Deepan Singh, MD · Maimonides Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-17

Primary Completion

2023-12-16

Completion

2023-12-16

FDA Drug

Yes

Countries

• United States

Study Locations