At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 34 enrolled
Drug / intervention
Dantrolene sodium for injectable suspensiondrug
Likely dose
Dantrolene sodium for injectable suspension 2 mg/kgfrom 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.
Phase 2, Single-Site, Open-Label, 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)
In Brief
A Phase 2 clinical trial evaluating Dantrolene sodium for injectable suspension for Heat Stroke. Completed, enrolled 34 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeat Stroke
CountriesSaudi Arabia
CollaboratorsQuintiles, Inc.
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartSep 2015
Primary CompletionSep 2015
Study CompletionOct 2015
TodayJul 2026
First PostedJul 31, 2015
Enrollment StartSep 1, 2015
Primary CompletionSep 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 10.9 years ago
Interventions
Dantrolene sodium for injectable suspensiondrug
Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg.