Levetiracetam for preventing seizures after brain tumor surgery
Official title: 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
Run by Beijing Tiantan Hospital · NCT07239115 · Data updated 2026-11-12
This trial tests whether giving levetiracetam around the time of brain tumor surgery can prevent postoperative seizures in adults who have not had seizures before.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 558 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | May 14, 2026 |
| Main results expected | January 2027 |
| Study ends | June 2027 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT07239115 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–75 undergoing craniotomy for supratentorial brain tumor resection with no prior seizures and no prior antiseizure medications, and adequate performance status.
✕Probably not a fit
Patients with factors predicting no seizure risk or who do not respond to prophylaxis may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, randomized, double-blind, placebo-controlled trial compares levetiracetam given starting 1 hour before supratentorial brain tumor resection and continuing for 3 months vs placebo. The primary outcome is seizure occurrence within 3 months after surgery; secondary outcomes include subclinical seizures, adverse events, and health economic measures. Eligible adults have no prior seizures, are undergoing craniotomy for a supratentorial tumor, and meet health criteria. The study aims to determine if routine perioperative prophylaxis with levetiracetam is beneficial and safe in this population.
Why it matters
Potential benefit: If successful, patients could receive a proven, safe method to reduce postoperative seizures after brain tumor surgery.
How similar studies have gone: Prior evidence is mixed; high-quality randomized trials like this are needed to establish efficacy for perioperative seizure prevention in brain tumor patients.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Beijing Tiantan Hospital, Capital Medical University
Beijing, China Recruiting
Study contacts
- Study coordinator: Xiu Dong Dr.Guan, MD
- Email: jwttyy@126.com
- Phone: +86-18801075852
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.