search
Back to results

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

Primary Purpose

Exertional Heat Stroke

Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Ryanodex and Standard of Care
Standard of Care
Sponsored by
Eagle Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exertional Heat Stroke

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

-

Sites / Locations

  • King Faisal Hospital
  • Mina al Jisr Hospital
  • Mina Al-Shari Al-Jadeed Hospital
  • Mina Al-Wadi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ryanodex and Standard of Care

Standard of Care only (SOC)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
July 17, 2018
Last Updated
April 28, 2021
Sponsor
Eagle Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03600376
Brief Title
Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 19, 2018 (Actual)
Primary Completion Date
August 14, 2019 (Actual)
Study Completion Date
August 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eagle Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exertional Heat Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Ryanodex (dantrolene sodium) for injectable suspension plus Standard of Care
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ryanodex and Standard of Care
Arm Type
Experimental
Arm Description
In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.
Arm Title
Standard of Care only (SOC)
Arm Type
Other
Arm Description
Standard of Care treatment will consist of the immediate start of cooling measures.
Intervention Type
Drug
Intervention Name(s)
Ryanodex and Standard of Care
Other Intervention Name(s)
Ryanodex and SOC
Intervention Description
Ryanodex to be administered as a rapid IV push
Intervention Type
Other
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
SOC
Intervention Description
Body cooling measures and supportive measures
Primary Outcome Measure Information:
Title
Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization]
Description
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).
Time Frame
90 minutes post-randomization
Secondary Outcome Measure Information:
Title
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]
Description
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).
Time Frame
Treatment duration, up to 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Hepner
Organizational Affiliation
Eagle Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
King Faisal Hospital
City
Mecca
Country
Saudi Arabia
Facility Name
Mina al Jisr Hospital
City
Mina
Country
Saudi Arabia
Facility Name
Mina Al-Shari Al-Jadeed Hospital
City
Mina
Country
Saudi Arabia
Facility Name
Mina Al-Wadi Hospital
City
Mina
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33848093
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs