A Phase 2 interventional study of Dantrolene sodium for injectable suspension in Heat Stroke, sponsored by Eagle Pharmaceuticals, Inc.. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-06-29.
Sponsored by Eagle Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered intravenously (IV), to current standard of care (SOC). SOC for the treatment of EHS is defined as effective body cooling, which should be implemented as quickly as available after diagnosis of exertional heat stroke.
The study will take place at emergency medical facilities.
Due to the life-threatening nature of exertional heat stroke (EHS), rapid assessment for inclusion into the study and subsequent immediate treatment must occur. Following initial triage and primary assessment of a subject, the subject's baseline status should be documented, and once a diagnosis of EHS is obtained, SOC treatment will be initiated immediately, the subject will be randomized to one of two treatment arms (SOC only or SOC plus Ryanodex).
Patients will be remain hospitalized for up to 72 hours after administration of the first dose of study drug and implemented SOC and will receive all necessary supportive measures until resolution of symptoms.
Study duration: 72 hours
21 studies on the registry are indexed under Heat Stroke; 10 are open to participants now.
This study's enrollment of 34 is close to 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.
Drug: Dantrolene sodium for injectable suspension
Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg.
Also known as: Ryanodex; EGL-4104
Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13
Number of subjects achieving a Glasgow Coma Scale(GCS) ≥ 13 at or prior to 90 minutes post-randomization. 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. The range of total GCS score is 3 to15 where a higher GCS score represents a better outcome. The scores of subscales are summed to determine the total score\*. A GCS score of 13-15 is considered Mild impairment of consciousness; a GCS score of 9-12 is considered Moderate impairment of consciousness; and a GCS score of 3-8 is considered Severe. \*Subscales: Eyes Response -Spontaneous=4; To sound =3; To Pressure=2; None=1; not tested. Verbal Response- Oriented=5; Confused=4; Words=3; Sounds=2; None-1; Not tested. Motor Response: Obeys Commands=6; Localizes=5; Normal Flexion=4; Abnormal Flexion=3; Extension=2; None=1; Not tested.
Time frame: 90 minutes post-randomization
| Milestone | Active | Control |
|---|---|---|
| Started | 17 | 17 |
| Treatment phase - up to 120 minutes | 17 | 17 |
| Completed | 17 | 17 |
| Not completed | 0 | 0 |
Number of subjects achieving a Glasgow Coma Scale(GCS) ≥ 13 at or prior to 90 minutes post-randomization. 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. The range of total GCS score is 3 to15 where a higher GCS score represents a better outcome. The scores of subscales are summed to determine the total score\*. A GCS score of 13-15 is considered Mild impairment of consciousness; a GCS score of 9-12 is considered Moderate impairment of consciousness; and a GCS score of 3-8 is considered Severe. \*Subscales: Eyes Response -Spontaneous=4; To sound =3; To Pressure=2; None=1; not tested. Verbal Response- Oriented=5; Confused=4; Words=3; Sounds=2; None-1; Not tested. Motor Response: Obeys Commands=6; Localizes=5; Normal Flexion=4; Abnormal Flexion=3; Extension=2; None=1; Not tested.
| Participants | Ryanodex Plus Standard of Care | Standard of Care |
|---|---|---|
| Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 | 5 | 2 |
Collected over .Up to 30 days post-discharge.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ryanodex | 1/17 (5.9%) | 4/17 (23.5%) | 17/17 (100%) |
| Standard of Care Only (SOC) | 0/17 (0%) | 3/17 (17.6%) | 17/17 (100%) |
| Event | Ryanodex | Standard of Care Only (SOC) |
|---|---|---|
| HypoxiaRespiratory, thoracic and mediastinal disorders | 2/17 | 0/17 |
| Disseminated intravascular coagulationBlood and lymphatic system disorders | 0/17 | 1/17 |
| Cardiac ArrestCardiac disorders | 1/17 | 0/17 |
| Cardio-Respiratory ArrestCardiac disorders | 1/17 | 0/17 |
| Diabetic KetoacidosisMetabolism and nutrition disorders | 0/17 | 1/17 |
| HypoglycemiaMetabolism and nutrition disorders | 0/17 | 1/17 |
| Acute Respiratory Distress SyndromeRespiratory, thoracic and mediastinal disorders | 0/17 | 1/17 |
| Event | Ryanodex | Standard of Care Only (SOC) |
|---|---|---|
| HypoxiaRespiratory, thoracic and mediastinal disorders | 2/17 | 6/17 |
| ChillsGeneral disorders | 0/17 | 3/17 |
| AgitationPsychiatric disorders | 2/17 | 3/17 |
| Blood Creatine Phosphokinase IncreasedInvestigations | 2/17 | 0/17 |
| Platelet Count DecreasedInvestigations | 1/17 | 2/17 |
| DehydrationInvestigations | 2/17 | 0/17 |
| DysphagiaGastrointestinal disorders | 1/17 | 0/17 |
| NauseaGastrointestinal disorders | 1/17 | 0/17 |
| VomitingGastrointestinal disorders | 1/17 | 0/17 |
| Alanine Aminotransferase IncreasedInvestigations | 1/17 | 0/17 |
| Age, Categorical(Participants) | Ryanodex Plus Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 17 | 34 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Ryanodex Plus Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| Female | 8 | 5 | 13 |
| Male | 9 | 12 | 21 |
| Race (NIH/OMB)(Participants) | Ryanodex Plus Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 3 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 1 | 2 | 3 |
| More than one race | 8 | 10 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Glasgow Coma Scale(units on a scale) | Ryanodex Plus Standard of Care | Standard of Care Only (SOC) | Total |
|---|---|---|---|
| Mean | 6.1 ± 3.98 | 5.9 ± 3.18 | 6.0 ± 3.55 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Dantrolene
Eagle Pharmaceuticals, Inc.