drugset / Trial / NCT02513095

Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)

NCT02513095

RandomizedParallel-groupOpen-labelTreatment

Summary

Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered intravenously (IV), to current standard of care (SOC). SOC for the treatment of EHS is defined as effective body cooling, which should be implemented as quickly as available after diagnosis of exertional heat stroke.

Timeline

Start
2015-09
Primary completion
2015-09
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Dantrolene Small molecule 1 mg/kg Intravenous
Subject Dantrolene Small molecule 2 mg/kg Intravenous