NCT03600376

Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS

Phase 3, Multi-Center, Double-Blind, Randomized, 2-Arm, Parallel Study to Assess the Efficacy and Safety of Ryanodex (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Eagle Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A double-blind, parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) compared to current Standard of Care (SOC) for EHS.

Detailed description

Following triage and primary assessment in the emergency medical facility, subjects will be randomized to 1 of 2 treatment arms, SOC plus Ryanodex or SOC only. Subjects will be dosed and followed for up to 6 hours post-randomization. Current SOC is limited to body cooling and supportive measures.

Conditions

• Exertional Heat Stroke

Interventions

Type	Name	Description
DRUG	Ryanodex and Standard of Care	Ryanodex to be administered as a rapid IV push
OTHER	Standard of Care	Body cooling measures and supportive measures

Timeline

• Start date: 2018-08-19
• Primary completion: 2019-08-14
• Completion: 2019-08-14
• First posted: 2018-07-26
• Last updated: 2021-05-19
• Results posted: 2021-04-26

Locations

4 sites across 1 country: Saudi Arabia

Regulatory

• FDA-regulated drug study