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

NCT02513095 | Completed Phase 2 Results

• 1 other identifier: EGL-4104-C-1502
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Heat Stroke

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13

  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.

  90 minutes post-randomization

Study Arms (2)

Ryanodex

EXPERIMENTAL

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

Standard of Care only (SOC)

NO INTERVENTION

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

Interventions

Dantrolene sodium for injectable suspension DRUG

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

Also known as: Ryanodex; EGL-4104

Ryanodex

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eagle Pharmaceuticals, Inc.: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Unknown Facility

Mecca, Saudi Arabia

Location

MeSH Terms

Conditions

Heat Stroke

Interventions

Dantrolene

Condition Hierarchy (Ancestors)

Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eagle Pharmaceuticals, Inc.

medinfo@eagleus.com

201 326 5300

Study Officials

• Adrian Hepner, MD

  Eagle Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 31, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 29, 2021
• Results First Posted: May 9, 2017

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)