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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT05779657
Eligibility Criteria:
Inclusion Criteria:
* Age from 6 month to 16 years.
* Generalized convulsive status epilepticus, defined as \> 5 minutes of clinically observed continuous or recurrent generalized, tonic-clonic seizure activity without regaining of consciousness.
Exclusion Criteria:
* Failure to obtain informed consent.
* Previous treatment with any antiseizure medication for the presenting seizure episode.
* Hypertension
* Alcohol intake
* Conditions associated with increased intracranial pressure (e.g., central nervous system mass lesions, hydrocephalus)
* Glaucoma
* Known allergy or contraindications to any of the study drugs.
* End-stage kidney disease.
* End stage liver disease
* Arrhythmia, severe heart disease, or pulmonary hypertension.
* Hyperthyroidism
* Pheochromocytoma
* Hypoglycemia or hyperglycemia.
* Inborn errors of metabolism.
* Known or suspected psychiatric disorder.
* Failure to obtain intravenous access in the first 5 minutes of stabilization phase.
* Cessation of seizures during the stabilization phase (0 - 5 minutes).
* Traumatic brain injury.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
16 Years
Study:
NCT05779657
Study Brief:
Protocol Section:
NCT05779657