Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi Syndrome (PWS-GXR)
Prader-Willi Syndrome, Aggression, Self-Injurious Behavior
About this trial
This is an interventional treatment trial for Prader-Willi Syndrome focused on measuring Adrenergic alpha-2 Receptor Agonist, Guanfacine, Adrenergic alpha-Agonists, Adrenergic Agonists, Adrenergic Agents
Eligibility 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.
Sites / Locations
- Maimonides Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Placebo
GXR
Immediately following the 8-week blinded randomized trial, an 8-week open-label continuation phase will be pursued to further define efficacy and tolerability of GXR, and to establish its safety with specific focus on metabolic profile.