Clinical trial · Interventional
Levetiracetam for Seizure Prevention After Brain Tumor Surgery
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Seizures After Brain Tumor Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levetiracetam | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Levetiracetam group
- description
- Participants receive levetiracetam 500 mg intravenously 1 hour before surgery and again on the evening after surgery (around 20:00-22:00), followed by oral levetiracetam 0.5 g twice daily from postoperative day 2 through 3 months. Intravenous infusion is given over approximately 15 minutes after dilution in 100 mL 0.9% sodium chloride or 5% glucose.
- interventionNames
- Drug: Levetiracetam
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Participants receive matching placebo solution intravenously 1 hour before surgery and again on the evening after surgery (around 20:00-22:00), followed by oral placebo tablets twice daily from postoperative day 2 through 3 months. The placebo is identical in appearance, packaging, and administration schedule to levetiracetam.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Undergoing craniotomy for supratentorial brain tumor resection. 2. Radiologically confirmed supratentorial brain tumor (excluding posterior fossa tumor, brainstem tumor, or gliomatosis cerebri). 3. Age between 18 and 75 years. 4. No history of seizures or epilepsy. 5. No prior use of antiepileptic drugs. 6. Karnofsky Performance Status (KPS) score ≥ 70. 7. Signed written informed consent Exclusion Criteria: 1. Concomitant brain injury (such as cerebrovascular accident, severe head trauma) or any intracranial disease other than tumor. 2. Pregnant or lactating women. 3. Intestinal stoma, cardiac disease, previous craniotomy for brain tumor resection, or intracranial infection. 4. Severe hepatic or renal dysfunction (defined as ALT or AST \>3× upper limit of normal; serum creatinine \>3.0 mg/dL \[265.2 μmol/L\] or eGFR \<30 mL/min/1.73m²). 5. Significant electrolyte imbalance (severe hyponatremia: serum sodium \<125 mmol/L; severe hypernatremia: serum sodium \>160 mmol/L; severe hypocalcemia: serum calcium \<2.5 mmol/L; or severe hypercalcemia: serum calcium \>6.5 mmol/L). 6. Long-term history of psychiatric disorders, alcoholism, or drug abuse. 7. Severe mental illness. 8. Allergy to or contraindication for antiepileptic drugs. 9. Unable to undergo MRI or EEG examination. 10. Deemed unsuitable for participation by the investigator. 11. Participation in another drug or device clinical trial within the past 3 months.
References
Publications (0)
Data not yet available