A Phase 3 interventional study of Ryanodex and Standard of Care and Standard of Care in Exertional Heat Stroke, sponsored by Eagle Pharmaceuticals, Inc.. Completed at 4 sites in Saudi Arabia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-05-19.
Sponsored by Eagle Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
21 studies on the registry are indexed under Heat Stroke; 10 are open to participants now.
This study's enrollment of 17 is below the median of 34 across 13 interventional studies indexed under Heat Stroke.
Browse Heat Stroke studies →Eagle Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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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 treatment will consist of the immediate start of cooling measures.
Other: Standard of Care
Ryanodex to be administered as a rapid IV push
Also known as: Ryanodex and SOC
Body cooling measures and supportive measures
Also known as: SOC
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).
Time frame: 90 minutes post-randomization
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).
Time frame: Treatment duration, up to 6 hours
| Milestone | Ryanodex and Standard of Care | Standard of Care Only (SOC) |
|---|---|---|
| Started | 9 | 8 |
| Completed | 7 | 2 |
| Not completed | 2 | 6 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Transferred to other facility | 1 | 0 |
| Withdrew: Investigator decision | 0 | 4 |
| Withdrew: Determined to be ineligible for study | 0 | 1 |
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).
| Participants | Ryanodex and Standard of Care | Standard of Care Only (SOC) |
|---|---|---|
| Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 [Time Frame: 90 Minutes Post-randomization] | 4 | 2 |
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).
| Participants | Ryanodex and Standard of Care | Standard of Care Only (SOC) |
|---|---|---|
| Pts. achieving GCS score ≥ 13 at 15 min post-randomization | 1 | 0 |
| Pts. achieving GCS score ≥ 13 at 30 min. post-randomization | 1 | 0 |
| Pts. achieving GCS score ≥ 13 after 45 min. post-randomization | 1 | 0 |
| Pts. achieving GCS score ≥ 13 after 60 min. post-randomization | 2 | 1 |
| Pts. achieving GCS score ≥ 13 after 75 min. post-randomization | 3 | 2 |
| Pts. achieving GCS score ≥ 13 after 90 min. post-randomization | 4 | 2 |
| Pts. achieving GCS score ≥ to 13 after 2 hr.. post-randomization | 5 | 2 |
| Pts. achieving GCS score ≥ 13 after 4 hr. post-randomization/follow-up phase | 5 | 2 |
| Pts. achieving GCS score ≥ 13 at end of study or early termination | 5 | 2 |
Collected over Adverse events data was collected from time of randomization through end of study (6 hours post-randomization) or early termination.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ryanodex and Standard of Care | 0/9 (0%) | 1/9 (11.1%) | 7/9 (77.8%) |
| Standard of Care Only (SOC) | 0/8 (0%) | 2/8 (25%) | 5/8 (62.5%) |
| Event | Ryanodex and Standard of Care | Standard of Care Only (SOC) |
|---|---|---|
| SeizureNervous system disorders | 0/9 | 1/8 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/9 | 1/8 |
| Coma Scale AbnormalInvestigations | 1/9 | 0/8 |
| Event | Ryanodex and Standard of Care | Standard of Care Only (SOC) |
|---|---|---|
| SeizureNervous system disorders | 0/9 | 3/8 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/9 | 1/8 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/9 | 1/8 |
| DiarrhoeaGastrointestinal disorders | 1/9 | 0/8 |
| NauseaGastrointestinal disorders | 1/9 | 0/8 |
| Coma Scale AbnormalInvestigations | 1/9 | 0/8 |
| Haemoglobin decreasedInvestigations | 1/9 | 0/8 |
| AcidosisMetabolism and nutrition disorders | 1/9 | 0/8 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/9 | 0/8 |
| AgitationNervous system disorders | 1/9 | 0/8 |
| Age, Continuous(years) | Ryanodex and Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| Mean | 55.3 ± 7.2 | 53.4 ± 11.2 | 54.4 ± 9.0 |
| Sex: Female, Male(Participants) | Ryanodex and Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| Female | 7 | 5 | 12 |
| Male | 2 | 3 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Ryanodex and Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 0 | 3 |
| Unknown or Not Reported | 6 | 8 | 14 |
| Race (NIH/OMB)(Participants) | Ryanodex and Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 4 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 0 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 4 | 6 |
| Region of Enrollment(participants) | Ryanodex and Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| Saudi Arabia | 9 | 8 | 17 |
| Weight(kg) | Ryanodex and Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| Mean | 86.1 ± 16.9 | 84.2 ± 12.9 | 85.2 ± 14.7 |
| Height(cm) | Ryanodex and Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| Mean | 162.8 ± 7.6 | 159.3 ± 7.7 | 161.3 ± 7.6 |
| BMI(kg/m^2) | Ryanodex and Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| Mean | 32.4 ± 5.9 | 33.2 ± 5.7 | 32.7 ± 5.6 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Eagle Pharmaceuticals, Inc.