Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS

NCT03600376 | Completed Phase 3 Results FDA Drug

• 1 other identifier: EGL-4104-C-1801
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

Brief Summary

A double-blind, parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) compared to current Standard of Care (SOC) for EHS.

Conditions

Exertional Heat Stroke

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization]

  The GCS is a validated and reliable scale to evaluate level of consciousness in patients with acute brain injury. The scale assesses 3 functions: Eye Opening, Verbal Response, and Motor Response. GCS scores range from 15 (best) to 3 (worst).

  90 minutes post-randomization

Secondary Outcomes (1)

• Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) Greater Than or Equal to 13 Over the Course of the Study [Time Frame: Study Duration]

  Treatment duration, up to 6 hours

Study Arms (2)

Ryanodex and Standard of Care

EXPERIMENTAL

In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.

Drug: Ryanodex and Standard of Care

Standard of Care only (SOC)

OTHER

Standard of Care treatment will consist of the immediate start of cooling measures.

Other: Standard of Care

Interventions

Ryanodex and Standard of Care DRUG

Ryanodex to be administered as a rapid IV push

Also known as: Ryanodex and SOC

Ryanodex and Standard of Care

Standard of Care OTHER

Body cooling measures and supportive measures

Also known as: SOC

Standard of Care only (SOC)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Eagle Pharmaceuticals, Inc.: lead

Study Sites (4)

King Faisal Hospital

Mecca, Saudi Arabia

Location

Mina al Jisr Hospital

Miná, Saudi Arabia

Location

Mina Al-Shari Al-Jadeed Hospital

Miná, Saudi Arabia

Location

Mina Al-Wadi Hospital

Miná, Saudi Arabia

Location

Related Publications (1)

• Fisher JD, Shah AP, Norozian F. Clinical Spectrum of Pediatric Heat Illness and Heatstroke in a North American Desert Climate. Pediatr Emerg Care. 2022 Feb 1;38(2):e891-e893. doi: 10.1097/PEC.0000000000002438.

  PMID: 33848093 DERIVED

MeSH Terms

Interventions

Dantrolene; Standard of Care

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

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

medinfo@eagleus.com

201-326-5300

Study Officials

• Adrian Hepner

  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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ryanodex (dantrolene sodium) for injectable suspension plus Standard of Care

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: August 19, 2018
• Primary Completion: August 14, 2019
• Study Completion: August 14, 2019
• Last Updated: May 19, 2021
• Results First Posted: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (4)