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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT05029960
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years with pathologic diagnosis of a supratentorial diffuse astrocytic or oligodendroglial tumor
* Patients must be able to provide informed consent
Exclusion Criteria:
* A pre-existing seizure disorder or epilepsy syndrome prior to tumor diagnosis
* Active maintenance therapy with an antiepileptic seizure drug (AED) prior to diagnosis of tumor
* Patients who have experienced an epileptic seizure as the presenting symptom of their brain tumor
* Predicted life expectancy of less than 6 months from the time of screening
* Pregnancy
* Patients with clinically significant hepatic disease (elevated aminotransferases \[bilirubin, alkaline phosphatase\] \> 3 times upper limit normal)
* Patients with stage 4 or greater renal disease (GFR \<30 mL/min/1.73 m2)
* Patients who are unable to swallow a tablet
* Patients with active suicidal ideation or a history of suicide attempt or other serious psychiatric disorder having required hospitalization within the previous 2 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05029960
Study Brief:
Protocol Section:
NCT05029960