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Levetiracetam for Seizure Prevention After Brain Tumor Surgery

RecruitingPhase 3

Sponsor: Beijing Tiantan Hospital

Conditions: Postoperative Seizures After Brain Tumor Surgery

Interventions: Levetiracetam, Placebo

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Beijing, China