In a recent webinar, Acadia Pharmaceuticals shared details of their COMPASS-PWS Clinical trial which is currently enrolling volunteers with PWS between the ages of 5 and 30 who experience hyperphagia. This phase 3 clinical trial aims to evaluate the safety and effectiveness of carbetocin on hyperphagia in PWS. Below is a summary of the webinar as well as the 20-minute recording.
Webinar Summary:
One characteristic of PWS is a deficiency of a naturally occurring hormone called oxytocin. Oxytocin regulates several functions in the body including hunger, anxiety, social behavior, and bonding. Carbetocin, an investigational drug similar to oxytocin, binds to oxytocin receptors with greater sensitivity, potentially making it more effective. Carbetocin has been widely used outside the U.S. in its intravenous form to prevent postpartum hemorrhage, establishing a strong safety profile.
Acadia is conducting a new phase 3 study to assess the safety and efficacy of a low dose of carbetocin nasal spray in treating hyperphagia in PWS. The study will involve 170 participants aged 5 to 30 with PWS. Half of the participants will receive carbetocin, while the other half will receive a placebo, in a double-blind setup.
Key eligibility criteria for the study include having PWS with hyperphagia, being between 5 and 30 years of age, and not having conditions like active upper respiratory infections or a history of brain trauma. Participants must also not have started new food-related interventions within the last month or participated in another treatment study within the last six months. Participant's medical histories will be reviewed prior to determining study eligibility.
COMPASS PWS involved 5 in-person clinic visits, beginning with a screening visit. Additional visits will be required at baseline, week 2, week 8, week 12. After the 12-week study, participants may enroll in an open-label extension study where everyone will receive carbetocin nasal spray for up to 3 years.
For more information on the study and enrollment, Acadia has provided a website, compasspws.com, which includes details on the study, a map of locations, and contact information.
