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

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 Heat Stroke (EHS)

Sponsors

Lead Sponsor: Eagle Pharmaceuticals, Inc.

Collaborator: Quintiles, Inc.

Source Eagle Pharmaceuticals, Inc.
Brief Summary

Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered intravenously (IV), to current standard of care (SOC). SOC for the treatment of EHS is defined as effective body cooling, which should be implemented as quickly as available after diagnosis of exertional heat stroke.

Detailed Description

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

Overall Status Completed
Start Date 2015-09-01
Completion Date 2015-10-01
Primary Completion Date 2015-09-01
Phase Phase 2
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 90 minutes post-randomization
Secondary Outcome
Measure Time Frame
Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 Over the Course of the Study Study duration
Enrollment 34
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dantrolene sodium for injectable suspension

Description: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg.

Arm Group Label: Ryanodex

Other Name: Ryanodex; EGL-4104

Eligibility

Criteria:

Inclusion Criteria: - Subjects may be entered in the study if they have a core body temperature obtained rectally of ≥ 40.0°C (104°F) - Recent history or suspected recent history (prior 24 hours) of performing intense physical activity (exertional activity) - The subject has an impaired consciousness level as evidenced by a GCS score < 13 - The subject has tachycardia (heart rate ≥ 100 bpm) Exclusion Criteria: - The subject is diagnosed with or is suspected of having an acute clinically severe infection, which in the opinion of the Investigator may increase the subject's risk for participating in the study and/or may impair the ability of performing and/or interpreting study assessments - The subject has severe hyperthermia secondary to a condition other than heat stroke (e.g., serotonin syndrome, thyrotoxicosis, pheochromocytoma, or brain hemorrhage) - There is likelihood of head trauma in the past 6 months, or other significant cardiovascular, pulmonary, hepatic, endocrine, or renal illness that in the opinion of the Investigator may increase the subject's risk for participating in the study and/or may impair the ability of performing and/or interpreting study assessments - A female subject has a positive pregnancy test (urine) or evidence of active lactation - Reported known use of potent CYP3A4 inhibitors - A known history of allergy or hypersensitivity to dantrolene - A history of chronic and ongoing assisted mechanical ventilation prior to the onset of EHS via an established artificial or supported airway (e.g., for severe chronic obstructive pulmonary disease [COPD], upper airway disease, impaired respiratory function). Note: Endotracheal intubation and mechanical ventilation as part of supportive measures for the treatment of EHS are allowed

Gender:

All

Minimum Age:

18 Years

Maximum Age:

45 Years

Healthy Volunteers:

No

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

Saudi Arabia

Verification Date

2017-03-01

Responsible Party

Type: Sponsor

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

Label: Ryanodex

Type: Experimental

Description: Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.

Label: Standard of Care only (SOC)

Type: No Intervention

Description: Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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