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

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ClinicalTrials.gov Identifier: NCT02513095
Recruitment Status : Completed
First Posted : July 31, 2015
Results First Posted : May 9, 2017
Last Update Posted : June 29, 2021
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heat Stroke Drug: Dantrolene sodium for injectable suspension Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Heat Stroke (EHS)
Study Start Date : September 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ryanodex
Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.
Drug: Dantrolene sodium for injectable suspension
Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg.
Other Name: Ryanodex; EGL-4104

No Intervention: Standard of Care only (SOC)
Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.



Primary Outcome Measures :
  1. Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [ Time Frame: 90 minutes post-randomization ]

    Number of subjects achieving a Glasgow Coma Scale(GCS) ≥ 13 at or prior to 90 minutes post-randomization. The Glasgow Coma Scale (GCS) is a reliable and objective way of recording the initial and subsequent level of consciousness in a person after a brain injury. The range of total GCS score is 3 to15 where a higher GCS score represents a better outcome. The scores of subscales are summed to determine the total score*. A GCS score of 13-15 is considered Mild impairment of consciousness; a GCS score of 9-12 is considered Moderate impairment of consciousness; and a GCS score of 3-8 is considered Severe.

    *Subscales: Eyes Response -Spontaneous=4; To sound =3; To Pressure=2; None=1; not tested. Verbal Response- Oriented=5; Confused=4; Words=3; Sounds=2; None-1; Not tested. Motor Response: Obeys Commands=6; Localizes=5; Normal Flexion=4; Abnormal Flexion=3; Extension=2; None=1; Not tested.




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02513095


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

Documents provided by Eagle Pharmaceuticals, Inc.:
Statistical Analysis Plan: Statistics  [PDF] November 2, 2016

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Responsible Party: Eagle Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02513095    
Other Study ID Numbers: EGL-4104-C-1502
First Posted: July 31, 2015    Key Record Dates
Results First Posted: May 9, 2017
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stroke
Heat Stroke
Sunstroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heat Stress Disorders
Wounds and Injuries
Dantrolene
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents