Phase 2
N=34
Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)
Heat Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02513095 ↗Enrolled (actual)
34
Serious AEs
20.6%
Results posted
May 2017
Primary outcome: Primary: Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 — 5; 2 Participants — p=0.396
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dantrolene sodium for injectable suspension (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eagle Pharmaceuticals, Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 |
5; 2 | 0.396 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects may be entered in the study if they have a core body temperature obtained rectally of ≥ 40.0°C (104°F)
- Recent history or suspected recent history (prior 24 hours) of performing intense physical activity (exertional activity)
- The subject has an impaired consciousness level as evidenced by a GCS score < 13
- The subject has tachycardia (heart rate ≥ 100 bpm)
Exclusion Criteria
- The subject is diagnosed with or is suspected of having an acute clinically severe infection, which in the opinion of the Investigator may increase the subject's risk for participating in the study and/or may impair the ability of performing and/or interpreting study assessments
- The subject has severe hyperthermia secondary to a condition other than heat stroke (e.g., serotonin syndrome, thyrotoxicosis, pheochromocytoma, or brain hemorrhage)
- There is likelihood of head trauma in the past 6 months, or other significant cardiovascular, pulmonary, hepatic, endocrine, or renal illness that in the opinion of the Investigator may increase the subject's risk for participating in the study and/or may impair the ability of performing and/or interpreting study assessments
- A female subject has a positive pregnancy test (urine) or evidence of active lactation
- Reported known use of potent CYP3A4 inhibitors
- A known history of allergy or hypersensitivity to dantrolene
- A history of chronic and ongoing assisted mechanical ventilation prior to the onset of EHS via an established artificial or supported airway (e.g., for severe chronic obstructive pulmonary disease [COPD], upper airway disease, impaired respiratory function). Note: Endotracheal intubation and mechanical ventilation as part of supportive measures for the treatment of EHS are allowed
Data sourced from ClinicalTrials.gov (NCT02513095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.