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

Phase 3

Completed

• Conditions: Exertional Heat Stroke
• Interventions: Drug: Ryanodex and Standard of Care; Other: Standard of Care

• Registration Number: NCT03600376
• Lead Sponsor: Eagle Pharmaceuticals, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Study Start: 2018-08-19
• Primary Completion: 2019-08-14
• Study Completion: 2019-08-14
• Results First Submitted: 2021-03-29
• Results First Submitted QC: 2021-03-29
• Status Verified: 2021-04
• Results First Posted: 2021-04-26
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 -

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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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ryanodex and Standard of Care	Ryanodex and Standard of Care	In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.
Standard of Care only (SOC)	Standard of Care	Standard of Care treatment will consist of the immediate start of cooling measures.

Primary Outcome Measures

Name	Time	Method
Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization]	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).

Secondary Outcome Measures

Name	Time	Method
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]	Treatment duration, up to 6 hours	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).

Trial Locations

Locations (4)

Mina al Jisr Hospital; 🇸🇦 Mina, Saudi Arabia

King Faisal Hospital; 🇸🇦 Mecca, Saudi Arabia

Mina Al-Wadi Hospital; 🇸🇦 Mina, Saudi Arabia

Mina Al-Shari Al-Jadeed Hospital; 🇸🇦 Mina, Saudi Arabia