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

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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

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Study Start (Actual) 2020-12-17

Primary Completion (Estimated) 2024-01-18

Study Completion (Estimated) 2024-01-18

Enrollment (Estimated) 33

Study Type INTERVENTIONAL

Phase PHASE4

Locations:

📍 Brooklyn, New York, United States

Eligibility Criteria

Description

Inclusion Criteria:

* Diagnosis of PWS confirmed by genetic testing documentation
* Rating of moderate or above on the Clinical Global Impression- Severity Scale

Exclusion Criteria:

* Subjects with positive pregnancy test, swallowing difficulty, and/or presenting with active psychosis or mania will be excluded
* Subjects currently taking guanfacine extended release
* Patients with lactose intolerance
* Individuals with pre-existing, clinically significant bradycardia (\< 8 years: \<64 bpm; 8 to 12 years: \<59 bpm; 12 to 16 years: \<53 bpm) or hypotension, defined as 5th percentile for height and gender,26 will be excluded from the study.
* Subjects receiving antipsychotic medications due to a documented history of psychosis or bipolar disorder will be allowed to continue taking the medication without dosage modification.
* Growth hormone, thyroid hormone replacement treatment, and non-psychiatric medicines will be allowed to continue.
* N-Acetyl Cysteine and anticonvulsant medication (only if prescribed for seizures) will be allowed to continue, with specific instructions to not make any dosage changes during the clinical trial.

Ages Eligible for Study: 6 Years to 35 Years (CHILD, ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-12-12
First Submitted that Met QC Criteria2022-12-12
First Posted2022-12-20

Study Record Updates

Last Update Submitted that Met QC Criteria2023-03-13
Last Update Posted2023-03-15
Last Verified2023-03