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

NCT ID: NCT02513095

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-10-31

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

Conditions

Heat Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ryanodex

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

Group Type: EXPERIMENTAL

Dantrolene sodium for injectable suspension

Intervention Type: DRUG

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

Standard of Care only (SOC)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Eagle Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Hepner, MD

Role: STUDY_DIRECTOR

Eagle Pharmaceuticals, Inc.

Locations

Mecca, , Saudi Arabia

Countries

Saudi Arabia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol Synopsis

View Document

Document Type: Statistical Analysis Plan: Statistics

View Document

Other Identifiers

EGL-4104-C-1502

Identifier Type: -

Identifier Source: org_study_id