Phase 3
Completed N=17
Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
Exertional Heat Stroke
Source: ClinicalTrials.gov NCT03600376 ↗
Enrolled (actual)
17
Serious AEs
17.7%
Results posted
Apr 2021
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
6citations · ~2 / year
Clinical Spectrum of Pediatric Heat Illness and Heatstroke in a North American Desert Climate.
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.
Linked Publications
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Clinical Spectrum of Pediatric Heat Illness and Heatstroke in a North American Desert Climate.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.