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

PHASE4CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

December 17, 2020

Primary Completion Date

December 16, 2023

Study Completion Date

December 16, 2023

Conditions
Prader-Willi SyndromeAggressionSelf-Injurious BehaviorPathologic ProcessesBehavioral SymptomsIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesChromosome DisordersGenetic Diseases, InbornObesityOvernutritionNutrition DisordersAntihypertensive AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPhysiological Effects of DrugsSkin-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.

Trial Locations (1)

11219

Maimonides Medical Center, Brooklyn

Sponsors
All Listed Sponsors
lead

Maimonides Medical Center

OTHER