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. This Phase 3 study of intranasal carbetocin (LV-101) is a randomized, double-blind study with an 8-week, placebo controlled period, followed by a long-term follow-up period of 56 weeks during which all participants will receive active treatment with LV-101. At Week 8, participants who were randomized to placebo in the placebo-controlled period will be randomized to one of the two LV-101 doses, administered three times per day before meals.
Recruitment Criteria
Study Type: Interventional
Eligible Ages: 7-18 years (estimated)
Other Criteria: PWS Nutritional Phase 3
Trial Details
Trial Id: NCT03649477
Phase: 3
Duration: 8 weeks of double blind, placebo controlled study, followed by 56 weeks of open label treatment
Status: not yet recruiting
Lead Sponsor: Levo
Countries: United States
Additional Details: Outcome measures include changes in hyperphagia behavior, obsessive and compulsive behaviors, anxiety and global impression
Eligibility Criteria
not yet available
This Study is enrolling at the following sites:
not yet available
