Sickle Cell Vaso-Occlusive Pain Crisis Treatment Study (EPIC) – Phase II

Evaluation of Purified Poloxamer 188 (MST 188) in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)

Protocol Description

The EPIC study evaluates whether purified poloxamer 188 (MST-188) can reduce the duration of vaso-occlusive pain crisis (VOC) in patients with sickle cell disease. The study will also evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a recurrence of VOC. Additionally, this study will compare the development of acute chest syndrome during VOC in patients who receive MST-188 to those who do not receive MST-188. “EPIC” stands for Evaluation of Purified Poloxamer 188 In Crisis.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting participants of both genders between the ages of 4 and 65 who have sickle cell disease and who have been admitted to the hospital because of their VOC.
Males: 4 to 65 years old
Females: 4 to 65 years old


Following initial screening, participants will be selected either to receive the study drug or a placebo via intravenous infusion for up to 49 hours. Tests, including blood and urine samples, will be done during the treatment phase. Following treatment, but while still in the hospital, participants will continue to be monitored for weight changes, vital signs, and pain relief. A 30-day follow-up visit with the study doctor and two follow-up phone check-ups are also part of the protocol.
Visits: Requires hospitalization
Duration: Varies depending on length of hospital stay

Status: Open for Enrollment

Source(s) of Support

Mast Therapeutics, Inc.

Primary Investigator

Debra Cohen, MD

Contact Information

For information about the study or enrollment, please contact:
Study Coordinator Angela Martino, BSN, RN