Phase 3 N=17 Randomized Double-blind Treatment

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

Exertional Heat Stroke

Bottom Line

View on ClinicalTrials.gov: NCT03600376 ↗

Enrolled (actual)

Serious AEs

17.7%

Results posted

Apr 2021

Primary outcome: Primary: Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization] — 4; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ryanodex and Standard of Care (Drug); Standard of Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eagle Pharmaceuticals, Inc.
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization]	4; 2	—
SECONDARY Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration]	1; 0; 1; 0; 1; 0	—

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.

Eligibility Criteria

Inclusion Criteria: Core body temperature of greater than or equal to 40.0 degrees C (104 degrees F); recent history of exertional activity; GCS score less than 13; tachycardia - Exclusion Criteria: clinical severe infection; hyperthermia secondary to another condition; endotracheal intubation;; sedative drugs administered prior to or at time of study entry; likelihood of head trauma within 6 months pre-study; positive pregnancy test; history of myocardial infection within 30 days; history of seizure disorder or epilepsy; concomitant or prior use of calcium channel blockers. -

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Data sourced from ClinicalTrials.gov (NCT03600376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.