A Long-term, Open-label Extension Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
Acadia ACP-101-303
What is the goal of the study?
This is a long-term, OLE study to evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS. Subjects who complete the antecedent double-blind study (ACP-101-302) will be invited to participate in the present study. The subject or legally acceptable representative (LAR) must provide written consent prior to the procedures being performed at the Week 12/end-of-treatment (EOT) visit of the antecedent study. A caregiver must also provide written consent to participate as an informant in study assessments prior to the procedures being performed at the Week 12/end-of-treatment (EOT) visit of the antecedent study. The data gathered at the Week 12/EOT visit of the antecedent study will serve as the baseline data of the present study.
Who can participate in the study?
Everyone