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

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ClinicalTrials.gov Identifier: NCT03600376
Recruitment Status : Completed
First Posted : July 26, 2018
Results First Posted : April 26, 2021
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Exertional Heat Stroke Drug: Ryanodex and Standard of Care Other: Standard of Care Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Ryanodex (dantrolene sodium) for injectable suspension plus Standard of Care
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 19, 2018
Actual Primary Completion Date : August 14, 2019
Actual Study Completion Date : August 14, 2019

Resource links provided by the National Library of Medicine


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 Name: Ryanodex and SOC

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 Name: SOC




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


Secondary Outcome Measures :
  1. 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] [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03600376


Locations
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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, Saudi Arabia
Sponsors and Collaborators
Eagle Pharmaceuticals, Inc.
Investigators
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Study Director: Adrian Hepner Eagle Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Eagle Pharmaceuticals, Inc.:
Study Protocol  [PDF] January 3, 2020
Statistical Analysis Plan  [PDF] January 3, 2020

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Responsible Party: Eagle Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03600376    
Other Study ID Numbers: EGL-4104-C-1801
First Posted: July 26, 2018    Key Record Dates
Results First Posted: April 26, 2021
Last Update Posted: May 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heat Stroke
Sunstroke
Heat Stress Disorders
Wounds and Injuries
Dantrolene
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents