CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
FE 992097 +1 moredrug
Likely dose
FE 992097 1.6 mgfrom 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.

Search/NCT01968187
NCT01968187Phase 2Completed
CompareCT.gov

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of Intranasal Carbetocin in Subjects With Prader-Willi Syndrome (PWS)

Ferring Pharmaceuticals·interventional·Posted Oct 23, 2013·Updated Mar 27, 2025

In Brief

A Phase 2 clinical trial evaluating FE 992097 and Placebo for Hyperphagia in Prader-Willi Syndrome. Completed, enrolled 38 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperphagia in Prader-Willi Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 23, 2013
Enrollment StartJan 20, 2014
Primary CompletionJul 16, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.7 years ago

Interventions

FE 992097drug

Each spray pump actuation delivered a 50 μL volume of solution that contained 1.6 mg carbetocin (FE 992097); each dose consisted of 3 spray pump actuations in each nostril that delivered a total of 9.6 mg carbetocin. Parents were instructed to administer 3 intranasal spray actuations in each nostril 3 times daily before meals for 14 days.

Placebodrug

Each spray pump actuation delivered a 50 μL volume of sterile sodium chloride solution 0.9%; each dose consisted of 3 spray pump actuations in each nostril. Parents were instructed to administer 3 intranasal spray actuations in each nostril 3 times daily before meals for 14 days.