Clinical Trial: Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 2, Single-Site, Open-Label, Randomized, 2-Arm Parallel Study to Assess the Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional The study will take place at emergency medical facilities.

Due to the life-threatening nature of exertional heat stroke (EHS), rapid assessment for inclusion into the study and subsequent immediate treatment must occur. Following initial triage and primary assessment of a subject, the subject's baseline status should be documented, and once a diagnosis of EHS is obtained, SOC treatment will be initiated immediately, the subject will be randomized to one of two treatment arms (SOC only or SOC plus Ryanodex).

Patients will be remain hospitalized for up to 72 hours after administration of the first dose of study drug and implemented SOC and will receive all necessary supportive measures until resolution of symptoms.

Study duration: 72 hours


Sponsor: Eagle Pharmaceuticals, Inc.

Current Primary Outcome: Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [ Time Frame: 90 minutes post-randomization ]

Cumulative incidence of subjects achieving a GCS ≥ 13 at or prior to 90 minutes post-randomization


Original Primary Outcome: Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [ Time Frame: 90 minutes post-randomization ]

Cumulative incidence of subjects achieving a GCS ≥ 13 at 90 minutes post-randomization


Current Secondary Outcome: Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 Over the Course of the Study [ Time Frame: Study duration ]

Cumulative incidence of subjects who achieve a GCS of ≥ 13 over the course of the study


Original Secondary Outcome: Same as current

Information By: Eagle Pharmaceuticals, Inc.

Dates:
Date Received: July 21, 2015
Date Started: September 2015
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017