Treatment of Hyperphagia Behavioral Symptoms in Children and Adults Diagnosed With Prader-Willi Syndrome

NCT01968187 ↗

Phase 2 Completed 38 enrolled Ferring Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2014-01-20
Primary completion: 2014-07-16
Completion: 2014-07-16

Outcome

Met primary endpoint

paper Patients receiving carbetocin had statistically significant reductions in HPWSQ-R total score at study end (-15.6) versus patients receiving placebo (-8.9; P = 0.029); PMID 29925684 ↗

registry analysis (other test); Carbetocin (FE 992097) vs Placebo; p = 0.0290; LS Mean Difference -6.7; ANCOVA NCT01968187 ↗

Publications

Dykens EM, Miller J, Angulo M, Roof E, Reidy M, Hatoum HT, Willey R, Bolton G, Korner P. Intranasal carbetocin reduces hyperphagia in individuals with Prader-Willi syndrome. JCI Insight. 2018 Jun 21;3(12):e98333. doi: 10.1172/jci.insight.98333. eCollection 2018 Jun 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carbetocin	Peptide	9.6 mg	Intranasal