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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.
Following triage and primary assessment in the emergency medical facility, subjects will be randomized to 1 of 2 treatment arms, SOC plus Ryanodex or SOC only. Subjects will be dosed and followed for up to 6 hours post-randomization. Current SOC is limited to body cooling and supportive measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard of Care only (SOC) | Other | Standard of Care treatment will consist of the immediate start of cooling measures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ryanodex and Standard of Care | Drug | Ryanodex to be administered as a rapid IV push |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 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). |
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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;; sedative drugs administered prior to or at time of study entry; likelihood of head trauma within 6 months pre-study; positive pregnancy test; history of myocardial infection within 30 days; history of seizure disorder or epilepsy; concomitant or prior use of calcium channel blockers.
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Hepner | Eagle Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Hospital | Mecca | Saudi Arabia | ||||
| Mina al Jisr Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33848093 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ryanodex and Standard of Care | In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered. Ryanodex and Standard of Care: Ryanodex to be administered as a rapid IV push |
| FG001 | Standard of Care Only (SOC) | Standard of Care treatment will consist of the immediate start of cooling measures. Standard of Care: Body cooling measures and supportive measures |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ryanodex and Standard of Care | In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered. Ryanodex and Standard of Care: Ryanodex to be administered as a rapid IV push |
| BG001 | Standard of Care Only (SOC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | 90 minutes post-randomization |
|
Adverse events data was collected from time of randomization through end of study (6 hours post-randomization) or early termination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ryanodex and Standard of Care | In addition to Standard of Care measures, Ryanodex (dantrolene sodium) for injectable suspension; 250 mg/vial will be administered. Ryanodex and Standard of Care: Ryanodex to be administered as a rapid IV push |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coma Scale Abnormal | Investigations | MedDra Version 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDra Version 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eagle Pharmaceuticals, Inc. | 201-326-5300 | medinfo@eagleus.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2020 | Mar 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 2020 | Mar 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003620 | Dantrolene |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
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Ryanodex (dantrolene sodium) for injectable suspension plus Standard of Care
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| Standard of Care | Other | Body cooling measures and supportive measures |
|
|
| Treatment duration, up to 6 hours |
| Miná |
| Saudi Arabia |
| Mina Al-Shari Al-Jadeed Hospital | Miná | Saudi Arabia |
| Mina Al-Wadi Hospital | Miná | Saudi Arabia |
| Investigator Decision |
|
| Determined to be ineligible for study |
|
Standard of Care treatment will consist of the immediate start of cooling measures. Standard of Care: Body cooling measures and supportive measures |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | It was not possible to obtain accurate height measurements for several patients due to the extreme nature of their medical condition. | Mean | Standard Deviation | cm |
|
| BMI | It was not possible to calculate BMI for several patients due to the extreme nature of their medical condition. | Mean | Standard Deviation | kg/m^2 |
|
| Glasgow Coma Scale Score | 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. Higher total GCS represents a better outcome. The scores of subscales are summed to determine the total score. The range of total GCS score is from 3 - 15 where 13-15 is Mild; 9 - 12 is Moderate; and 3 -8 is Severe. | Mean | Standard Deviation | units on a scale |
|
| Rectal Temperature | Mean | Standard Deviation | Degrees Celsius |
|
Standard of Care treatment will consist of the immediate start of cooling measures. Standard of Care: Body cooling measures and supportive measures |
|
|
| Secondary | 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] | 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). | the outcome measure data table below is a summary of results showing the cumulative proportion of subjects achieving GCS score ≥13 post-randomization at all planned time points. Data is cumulative therefore the counts in the categories below will not add up to the Number Analyzed. score ≥ 13 post-randomization at all planned time points in the study is shown | Posted | Count of Participants | Participants | Treatment duration, up to 6 hours |
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| 7 |
| 9 |
| EG001 | Standard of Care Only (SOC) | Standard of Care treatment will consist of the immediate start of cooling measures. Standard of Care: Body cooling measures and supportive measures | 0 | 8 | 2 | 8 | 5 | 8 |
| Seizure | Nervous system disorders | MedDra Version 21.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra Version 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDra Version 21.0 | Systematic Assessment |
|
| Coma Scale Abnormal | Investigations | MedDra Version 21.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDra Version 21.0 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDra Version 21.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDra Version 21.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDra Version 21.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDra Version 21.0 | Systematic Assessment |
|
| Agitation | Nervous system disorders | MedDra Version 21.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra Version 21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDra Version 21.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDra Version 21.0 | Systematic Assessment |
|
The PIs are not permitted to discuss or publish study results.
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Pts. achieving GCS score ≥ 13 after 45 min. post-randomization |
|
| Pts. achieving GCS score ≥ 13 after 60 min. post-randomization |
|
| Pts. achieving GCS score ≥ 13 after 75 min. post-randomization |
|
| Pts. achieving GCS score ≥ 13 after 90 min. post-randomization |
|
| Pts. achieving GCS score ≥ to 13 after 2 hr.. post-randomization |
|
| Pts. achieving GCS score ≥ 13 after 4 hr. post-randomization/follow-up phase |
|
| Pts. achieving GCS score ≥ 13 at end of study or early termination |
|