Levetiracetam for Seizure Prevention After Brain Tumor Surgery (NCT07239115) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Levetiracetam for Seizure Prevention After Brain Tumor Surgery
China558 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Undergoing craniotomy for supratentorial brain tumor resection.
. 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).
✕. 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).
✕. Long-term history of psychiatric disorders, alcoholism, or drug abuse.
✕. Severe mental illness.
✕. Allergy to or contraindication for antiepileptic drugs.