Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT02513095
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02513095
Study Brief:
Protocol Section:
NCT02513095