Overview

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

Status:
Completed

Trial end date:
2019-08-14

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Eagle Pharmaceuticals, Inc.

Treatments:

Dantrolene

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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