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:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT02409433
Eligibility Criteria:
Inclusion Criteria:
* Traumatic Brain Injury (TBI) or Subarachnoid hemorrhage (SAH)
* Admitted to the hospital less than 48 hours prior to randomization
* Glasgow Coma Scale (GCS) score 3-8 (inclusive), or GCS motor score of five or less and abnormal CT scan showing intracranial pathology
* Hemodynamically stable
* Older than 18 years of age
Exclusion Criteria:
* No IV access
* Spinal cord injury
* History of or CT confirmation of previous brain injury, including brain tumor, stroke, or a spontaneous intracerebral hemorrhage
* Hemodynamically unstable
* Suspected anoxia
* Liver failure
* Younger than 18 years of age
* Pregnant
* Allergy to phenytoin or lacosamide
* Inability to obtain consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02409433
Study Brief:
Protocol Section:
NCT02409433