Short Versus Long-term Levetiracetam in Brain Tumors
Levetiracetam is the commonly preferred anti-seizure medicine in patients with brain tumors. This drug has reduced the risk of seizure events occurring but is associated with a risk of side effects such as increased headache, drowsiness, loss of muscle coordination, and psychological challenges in patients. In patients
| Condition(s) | Seizures, Brain Tumors, Antiepileptics, Levetiracetam |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Levetiracetam is the commonly preferred anti-seizure medicine in patients with brain tumors. This drug has reduced the risk of seizure events occurring but is associated with a risk of side effects such as increased headache, drowsiness, loss of muscle coordination, and psychological challenges in patients. In patients undergoing appropriate treatment for brain tumors and controlled of seizures in the initial few months of levetiracetam, the chance of further seizures is relatively low. The optimal duration to give levetiracetam is not well defined for these patients, and currently as standard treatment levetiracetam is continued for 2-3 years. This study aims to answer this question by comparing patients on a short course of levetiracetam (experimental arm) versus a longer course of levet |
| Who can participate | Inclusion Criteria: • Age ≥ 18years * 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 Exclusion Criteria: * KPS \< 50 * No history of seizure * Unclear history of seizure episodes in the past * Use of antiepileptics other than levetiracetam in the previous 6 months * No histological diagnosis * Progressive disease * Brain metastasis * Altered mental status with deficits in understanding or inability to consent to the study |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tata Memorial Centre |
| Locations | Udupi, Karnataka, India; Mumbai, Maharashtra, India |
| Start date | 2024-07-04 |
| NCT ID | NCT06442748 |
| Official listing | https://clinicaltrials.gov/study/NCT06442748 |