EPIC: MST-188 Injection For Sickle Cell Disease Vaso-Occlusive Crisis

Study title

Evaluation of Purified Poloxamer 188 in Children in Crisis (EPIC): A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of MST-188 (Purified Poloxamer 188) Injection in Children with Sickle Cell Disease Experiencing Vaso-Occlusive Crisis

Study objectives

Demonstrate the efficacy of MST-188 in reducing the duration of vaso-occlusive crisis in subjects with sickle cell disease.

Compare the re-hospitalization rate (for VOC) between the treatment arms and to compare the occurrence of acute chest syndrome between the treatment arms.

Eligibility

All sickle cell disease patients with hemoglobin SS or Sβ0 who present to the Emergency department or Hematology for pain and are being admitted for management with parenteral opioid analgesia.

PI: Kim Smith-Whitley, MD

SC: Henrietta Enninful–Eghan, Tannoa Jackson

Sponsor: Mast Therapeutics, Inc.

Reviewed on April 17, 2014