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)

Sponsors

Lead Sponsor: Eagle Pharmaceuticals, Inc.

Source 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.

Overall Status Completed
Start Date 2018-08-19
Completion Date 2019-08-14
Primary Completion Date 2019-08-14
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure 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] 90 minutes post-randomization
Secondary Outcome
Measure 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] Study duration
Enrollment 17
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ryanodex and Standard of Care

Description: Ryanodex to be administered as a rapid IV push

Arm Group Label: Ryanodex and Standard of Care

Other Name: Ryanodex and SOC

Intervention Type: Other

Intervention Name: Standard of Care

Description: Body cooling measures and supportive measures

Arm Group Label: Standard of Care only (SOC)

Other Name: SOC

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. -

Gender:

All

Minimum Age:

18 Years

Maximum Age:

99 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Adrian Hepner Study Director Eagle Pharmaceuticals, Inc.
Location
Facility:
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
Location Countries

Saudi Arabia

Verification Date

2019-12-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ryanodex and Standard of Care

Type: Experimental

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

Label: Standard of Care only (SOC)

Type: Other

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Ryanodex (dantrolene sodium) for injectable suspension plus Standard of Care

Primary Purpose: Treatment

Masking: Double (Participant, Care Provider)

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