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 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT01463033
Eligibility Criteria:
Inclusion Criteria:
* Acute head injury associated with one of the following:
Intracranial hemorrhage, including epidural, subdural and intracerebral hemorrhage or with cerebral contusion(s) of any size; Penetrating (foreign body) head injury; Skull fracture and dural tear; Seizure within 8 hours of head injury
* Onset of head injury within 8-hours of proposed treatment initiation.
* Glasgow Coma Scale 6-15.
Exclusion Criteria:
* Clinical contraindications:
* Previous epilepsy or status epilepticus.
* Any systemic illness or unstable medical condition that might pose additional risk, including: renal insufficiency, other unstable metabolic or endocrine disturbances, and active systemic cancer.
* Psychosis within six months of enrollment as determined by history of hospitalization for psychosis or medications for psychosis.
* Moderate to severe mental retardation (IQ\< 55 or\>2 school grade levels below the expected for age \[expected age = grade level +5\]).
* Clinical/Laboratory Indicators:
* Serum creatinine \> 1.5 on the day of treatment initiation for adults.
* Serum creatinine ≥1.5 for subjects ≥17 years old, ≥1.0 for subjects 13-17 years old and ≥0.7 for subjects 6-12 years old.
* Pregnancy
* Use of any CNS-active investigational drugs within 3 months of enrollment.
* Use of Antiepileptic Drugs (AEDs) within two months of enrollment, for any indication.
* Allergy/sensitivity to study drugs or their formulations:
* Active drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements:
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT01463033
Study Brief:
Protocol Section:
NCT01463033