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

Phase 3, Multi-Center, Double-Blind, 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)

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.

Study Overview

• Status: Completed
• Conditions: Exertional Heat Stroke
• Intervention / Treatment: Drug: Ryanodex and Standard of Care; Other: Standard of Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Mecca, Saudi Arabia
    • King Faisal Hospital
  • Mina, Saudi Arabia
    • Mina al Jisr Hospital
  • Mina, Saudi Arabia
    • Mina Al-Shari Al-Jadeed Hospital
  • Mina, Saudi Arabia
    • Mina Al-Wadi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ryanodex and Standard of Care; In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.	Drug: Ryanodex and Standard of Care; Ryanodex to be administered as a rapid IV push; Other Names: Ryanodex and SOC
Other: Standard of Care only (SOC); Standard of Care treatment will consist of the immediate start of cooling measures.	Other: Standard of Care; Body cooling measures and supportive measures; Other Names: SOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization]	The GCS is a validated and reliable scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst).	90 minutes post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	The GCS is a validated and reliable scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst).	Treatment duration, up to 6 hours

Collaborators and Investigators

• Sponsor: Eagle Pharmaceuticals, Inc.
• Investigators: Study Director: Adrian Hepner, Eagle Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Fisher JD, Shah AP, Norozian F. Clinical Spectrum of Pediatric Heat Illness and Heatstroke in a North American Desert Climate. Pediatr Emerg Care. 2022 Feb 1;38(2):e891-e893. doi: 10.1097/PEC.0000000000002438.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2018
• Primary Completion (Actual): August 14, 2019
• Study Completion (Actual): August 14, 2019

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Heat Stress Disorders; Heat Stroke; Sunstroke; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Muscle Relaxants, Central; Dantrolene
• Other Study ID Numbers: EGL-4104-C-1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No