At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 130 enrolled
Drug / intervention
3.2 mg intranasal carbetocin +2 moredrug
Likely dose
3.2 mg intranasal carbetocinfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3, Randomized, Double-Blind, Placebo-Controlled, 8-week Clinical Study to Assess the Efficacy, Safety, and Tolerability, of Intranasal Carbetocin (LV-101) in Prader-Willi Syndrome (PWS) With Long Term Follow-Up (CARE-PWS)
In Brief
A Phase 3 clinical trial evaluating 3.2 mg intranasal carbetocin, 9.6 mg intranasal carbetocin, and 1 other intervention for Prader-Willi Syndrome. Completed, enrolled 130 participants across 24 sites in 3 countries.
Detailed Summary
This Phase 3 study is designed to test the effectiveness of intranasal carbetocin (LV-101) in participants with Prader-Willi syndrome (PWS). Carbetocin is an oxytocin analog (a man-made chemical that is like oxytocin). This study will also evaluate the safety and tolerability of LV-101.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrader-Willi Syndrome
CountriesAustralia, Canada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartNov 2018
Primary CompletionMay 2020
Study CompletionJul 2022
TodayJul 2026
First PostedAug 28, 2018
Enrollment StartNov 20, 2018
Primary CompletionMay 13, 2020
Study CompletionJul 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.8 years ago
Interventions
3.2 mg intranasal carbetocindrug
three times per day with meals
9.6 mg intranasal carbetocindrug
three times per day with meals
placebodrug
three times per day with meals