Study Purpose
Carbetocin (LV-101) is an investigational drug that was created to have effects in the body like oxytocin. Carbetocin is not approved in the United States, but is approved in some other countries for treatment of women with excessive bleeding after giving birth via caesarean section.
Results from a Phase 2 study evaluating Carbetocin for PWS have been published and results were favorable. Further development, including the Phase 3 study, will be pursued by Levo Therapeutics. The Phase 3 study is expected to enroll individuals with PWS, age 7-18 years old, who will receive carbetocin or placebo by intranasal spray. Effects on hyperphagia (excessive appetite), will be measured. An 'open label' period, where all participants can receive carbetocin for at least a year, is planned. Plans for the Phase 3 study are subject to change.
Recruitment Criteria
Study Type: protocol not yet available
Eligible Ages: 7-18 years (estimated)
Other Criteria:
Trial Details
Trial Id:
Phase: 3
Duration: protocol not yet available
Status: not yet recruiting
Lead Sponsor: Levo
Countries: United States
Additional Details:
Eligibility Criteria
not yet available
This Study is enrolling at the following sites:
not yet available
