NCT07239115RecruitingPhase 3
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 · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 558 (estimated)
- First submitted
- 16 Nov 2025
- Start date
- 14 May 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Epilepsy
- NCT number
- NCT07239115
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 558
- From 14 May 2026 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant brain injury (such as cerebrovascular accident, severe head trauma) or any intracranial disease other than tumor.
- Intestinal stoma, cardiac disease, previous craniotomy for brain tumor resection, or intracranial infection.
- Participation in another drug or device clinical trial within the past 3 months.
Other illness
- Long-term history of psychiatric disorders, alcoholism, or drug abuse.
- Severe mental illness.
- Allergy to or contraindication for antiepileptic drugs.
Lab values
- 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).
Other
- Pregnant or lactating women.
- Unable to undergo MRI or EEG examination.
- Deemed unsuitable for participation by the investigator.
Who the study is looking for
- Undergoing craniotomy for supratentorial brain tumor resection.
- Radiologically confirmed supratentorial brain tumor (excluding posterior fossa tumor, brainstem tumor, or gliomatosis cerebri).
- Age between 18 and 75 years.
- No history of seizures or epilepsy.
- No prior use of antiepileptic drugs.
- Karnofsky Performance Status (KPS) score ≥ 70.
- Signed written informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.