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Perioperative Randomized Evaluation of leVetiracetam's Efficacy and Safety for Epilepsy Prevention in Neurosurgical Tumor Patients (PREVENT): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Trial
This study aims to evaluate the efficacy and safety of levetiracetam for the prevention of postoperative seizures in adult patients undergoing supratentorial brain tumor surgery. It is a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive levetiracetam or placebo, starting 1 hour before surgery and continuing for 3 months postoperatively. The primary outcome is the incidence of clinical seizures within 3 months after surgery. Secondary outcomes include subclinical seizures within 7 days and 3 months postoperatively, adverse events within 3 months, and health economic outcomes. The study aims to clarify the role of levetiracetam in the primary prevention of perioperative seizures in brain tumor patients and to provide evidence for rational use of antiseizure medications in neurosurgical practice.
Details
| Lead sponsor | Beijing Tiantan Hospital |
|---|---|
| Phase | Phase 3 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 558 |
| Start date | 2026-01 |
| Completion | 2027-06 |
Conditions
- Postoperative Seizures After Brain Tumor Surgery
Interventions
- Levetiracetam
- Placebo
Primary outcomes
- Incidence of postoperative clinical seizures within 90 days after surgery — Within 90 days after surgery
The occurrence of one or more postoperative clinical seizures within 90 days after supratentorial brain tumor resection, confirmed by treating physicians and reviewed by independent neurologists. A clinical seizure is defined as a transient occurrence of signs or symptoms resulting from abnormal excessive or synchronous neuronal activity in the brain, with or without electrographic correlation. Seizure episodes will be classified according to the International League Against Epilepsy (ILAE) 2017 operational classification
Countries
China