CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 17 enrolled
Drug / intervention
Ryanodex and Standard of Care +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03600376
NCT03600376Phase 3Completed

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)

Eagle Pharmaceuticals, Inc.·interventional·Posted Jul 26, 2018·Updated May 19, 2021

In Brief

A Phase 3 clinical trial evaluating Ryanodex and Standard of Care and Standard of Care for Exertional Heat Stroke. Completed, enrolled 17 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSaudi Arabia
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 26, 2018
Enrollment StartAug 19, 2018
Primary CompletionAug 14, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.9 years ago

Interventions

Ryanodex and Standard of Caredrug

Ryanodex to be administered as a rapid IV push

Standard of Careother

Body cooling measures and supportive measures