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

NCT03600376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-05-19

Study results available
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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

Interventions

DRUG

Ryanodex and Standard of Care

Ryanodex to be administered as a rapid IV push

OTHER

Standard of Care

Body cooling measures and supportive measures

Sponsors & Collaborators

  • Eagle Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Adrian Hepner · Eagle Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-19
Primary Completion
2019-08-14
Completion
2019-08-14
FDA Drug
Yes

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600376 on ClinicalTrials.gov