Carbetocin (ACP-101) is an investigational drug that binds with oxytocin receptors with greater sensitivity than oxytocin, a naturally occurring hormone. Carbetocin is not approved in the United States but is approved in some other countries for the treatment of women with excessive bleeding after giving birth via cesarean section.
In this Phase 3 study, carbetocin nasal spray or placebo will be inhaled through the nose three times each day. This study will last approximately 19 weeks and will involve up to 5 in-person visits to the study center. Eligible participants will be randomly assigned to study drug or placebo. Upon completion of the study treatments, participants are invited to join a long-term extension study in which all participants will receive carbetocin nasal spray for up to 36 months.
Study drug, clinic visits, and study-related procedures are provided at no cost. You may also be reimbursed for time and travel expenses.
Study Type: Interventional
Eligible Ages: 5-30 years
- Between the ages of 5 and 30
- Have increased appetite
- Live with a caregiver who can attend study visits with the participant
- Have not used oxytocin, desmopressin (DDAVP), or tesofensine within 6 months of starting the study treatment
- Additional tests and the participant's medical history will be reviewed to determine eligibility.
This study will be available at the following sites:
For an up-to-date list of trial sites, click here to visit the COMPASSPWS page.