Levetiracetam: Levetiracetam 500 mg (5 mL) for intravenous infusion administered 1 hour before surgery and again on the evening after surgery (approximately 20:00-22:00), diluted in 100 mL 0.9% sodium chloride or 5% glucose and infused over about 15 minutes. From postoperative day 2 through 3 months, oral levetiracetam tablets 0.5 g twice daily (or via nasogastric route if oral intake not feasible) are administered.
Placebo: Matching placebo solution (5 mL) for intravenous infusion 1 hour before surgery and again on the evening after surgery (approximately 20:00-22:00), diluted in 100 mL 0.9% sodium chloride or 5% glucose and infused over about 15 minutes. From postoperative day 2 through 3 months, matching placebo tablets are given twice daily (oral or via nasogastric route). Placebo formulation, packaging, and administration schedule are identical to those of levetiracetam.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Beijing Tiantan Hospital, Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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