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

Eagle Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Exertional Heat Stroke

Treatments: Other: Standard of Care; Drug: Ryanodex and Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT03600376

EGL-4104-C-1801

Details and patient eligibility

About

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.

Full description

Following triage and primary assessment in the emergency medical facility, subjects will be randomized to 1 of 2 treatment arms, SOC plus Ryanodex or SOC only. Subjects will be dosed and followed for up to 6 hours post-randomization. Current SOC is limited to body cooling and supportive measures.

Enrollment: 17 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

17 participants in 2 patient groups

Ryanodex and Standard of Care

Experimental group

Description:

In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.

Treatment:

Drug: Ryanodex and Standard of Care

Standard of Care only (SOC)

Other group

Description:

Standard of Care treatment will consist of the immediate start of cooling measures.

Treatment:

Other: Standard of Care