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Ryanodex and Standard of Care

Phase 3

Exertional Heat Stroke | Small Molecules | Neurology |Eagle Pharmaceuticals, Inc.|Trials Updated: May 19, 2021

Ryanodex and Standard of Care development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jul 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Ryanodex and Standard of Care clinical trials

Ryanodex and Standard of Care · 1 trial · 1 indication

Phase 3 1
NCT03600376Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHSExertional Heat Stroke
COMPLETED17 Analytics
PHASE3COMPLETED
Study to Assess the Efficacy and Safety of Ryanodex as Adjuvant Treatment in Subjects With EHS
Exertional Heat Stroke
NCT0360037617
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ryanodex and Standard of CareEXPERIMENTALIn addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered.
Standard of Care only (SOC)OTHERStandard of Care treatment will consist of the immediate start of cooling measures.

Interventions

NameTypeDescription
Ryanodex and Standard of CareDRUGRyanodex to be administered as a rapid IV push
Standard of CareOTHERBody cooling measures and supportive measures
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Core body temperature of greater than or equal to 40.0 degrees C (104 degrees F); recent history of exertional activity; GCS score less than 13; tachycardia - Exclusion Criteria: clinical severe infection; hyperthermia secondary to another condition; endotracheal intubation;; se...

Countries:Saudi Arabia
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