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 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT07271966
Eligibility Criteria:
Inclusion Criteria for Patients:
1. Age ≥ 18 years
2. Diagnosed with a primary brain tumor
3. Karnofsky Performance Status ≥ 70%
4. Have one or more documented seizures or transient events concerning for localization-related epilepsy requiring anti-seizure medication prophylaxis
5. Have an active immediate release levetiracetam prescription
6. Taking levetiracetam for ≥ 6 weeks and ≤ 6 months before screening
7. Baseline patient-reported mood symptoms and/or National Comprehensive Cancer Network distress thermometer score ≥ 3
8. Has access to e-mail where they can receive electronic informed consent form (ICF) and questionnaires
9. Signed ICF approved by the institutional review board (IRB)
Inclusion Criteria for Caregivers:
1. Age ≥ 18 years
2. Patient has indicated that it is acceptable to recruit their caregivers into the study
3. Able to read and write English
4. Has access to e-mail where they can receive electronic ICF and questionnaires
5. Signed ICF approved by the IRB
Exclusion Criteria for Patients:
1. Active prescription for steroids at the time of enrollment
2. Prescription for extended-release levetiracetam
3. Previous history of suicidal ideation, homicidal ideation, hallucinations, psychosis, depression leading to hospitalization, or mood disturbance leading to hospitalization
4. Prior history of alcohol use disorder or substance use disorder
5. Refractory epilepsy requiring second or third line anti-seizure medication in addition to levetiracetam at the time of enrollment
6. Patients who are currently pregnant or breastfeeding/chestfeeding
7. Patients with a pre-existing history of neuropathy
8. Known history of Vitamin B6 toxicity or deficiency
9. Prior history of gastric surgery or colectomy
10. Prior history of autoimmune disease, such as Crohn's, Ulcerative Colitis, or Celiac disease
11. Prescribed Theophylline (Aquaphyllin, Elixophyllin, Theolair, Truxophyllin) used in the treatment of asthma, chronic bronchitis, and emphysema
12. Cognitive impairment that affects the patient's ability to comprehend and provide responses to questionnaires
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07271966
Study Brief:
Protocol Section:
NCT07271966