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

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

Outcome

Missed primary endpoint

registry analysis (superiority test); Ryanodex Plus Standard of Care vs Standard of Care; p = 0.396 NCT02513095 ↗

Drugs

Indications