Short versus Long-term Levetiracetam in Brain Tumors
Phase 3
- Conditions
- Health Condition 1: C719- Malignant neoplasm of brain, unspecified
- Registration Number
- CTRI/2024/06/069498
- Lead Sponsor
- Tata Memorial Centre Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
History of seizure
Histological diagnosis of primary brain tumor
Supratentorial location of primary tumor
Controlled on levetiracetam monotherapy for 6 months
Index surgery within 1 year
Karnofsky Performance Scale (KPS) = 50
Imaging within the previous 6 months demonstrating radiologically stable disease status and clinical stability during screening.
Exclusion Criteria
Include the cumulative incidence of seizures impacting awareness
2-year seizure-free survival in each stratum.
Quality of life assessment
Cost-benefit analysis
Progression-free survival
Overall survival
Post hoc analysis per histological category for seizure control
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method