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

Exertional Heat Stroke Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600376
• Other study ID #: EGL-4104-C-1801
• Status: Completed
• Phase: Phase 3
• Start date: August 19, 2018
• Est. completion date: August 14, 2019

Study information

• Verified date: April 2021
• Source: Eagle Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 14, 2019
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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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Related Conditions & MeSH terms

• Exertional Heat Stroke
• Heat Stroke

Intervention

Drug:
• Ryanodex and Standard of Care
Ryanodex to be administered as a rapid IV push

Other:
• Standard of Care
Body cooling measures and supportive measures

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Hospital	Mecca
Saudi Arabia	Mina al Jisr Hospital	Mina
Saudi Arabia	Mina Al-Shari Al-Jadeed Hospital	Mina
Saudi Arabia	Mina Al-Wadi Hospital	Mina

Sponsors (1)

Lead Sponsor	Collaborator
Eagle Pharmaceuticals, Inc.

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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