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

• Status: Recruiting
• Trial end date: 2023-02-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimonides Medical Center
• Treatments: Guanfacine

Criteria

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.