Levetiracetam for Seizure Prevention After Brain Tumor Surgery

NCT07239115 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: KY2025-213-02
• Study Type: interventional
• Target: 558
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Seizures After Brain Tumor Surgery

Keywords

Levetiracetam; Perioperative prophylaxis; Postoperative seizures; Tumor-related epilepsy; Antiseizure medication; PREVENT trial

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative clinical seizures 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

  Within 90 days after surgery

Secondary Outcomes (2)

• Incidence of postoperative subclinical seizures detected by EEG

  Within 7 days and 3 months after surgery

• Safety outcomes: incidence of adverse events, serious adverse events, and all-cause mortality within 3 months after surgery

  Within 3 months after surgery

Other Outcomes (2)

• Economic outcomes: direct medical, direct non-medical, and indirect costs within 3 months after surgery

  Within 3 months after surgery

• Incidence of postoperative clinical seizures within 6 months after surgery

  Within 6 months after surgery

Study Arms (2)

Levetiracetam group

EXPERIMENTAL

Participants receive levetiracetam 500 mg intravenously 1 hour before surgery and again on the evening after surgery (around 20:00-22:00), followed by oral levetiracetam 0.5 g twice daily from postoperative day 2 through 3 months. Intravenous infusion is given over approximately 15 minutes after dilution in 100 mL 0.9% sodium chloride or 5% glucose.

Drug: Levetiracetam

Placebo group

PLACEBO COMPARATOR

Participants receive matching placebo solution intravenously 1 hour before surgery and again on the evening after surgery (around 20:00-22:00), followed by oral placebo tablets twice daily from postoperative day 2 through 3 months. The placebo is identical in appearance, packaging, and administration schedule to levetiracetam.

Drug: Placebo

Interventions

Levetiracetam DRUG

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.

Levetiracetam group

Placebo DRUG

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concomitant brain injury (such as cerebrovascular accident, severe head trauma) or any intracranial disease other than tumor.
• Pregnant or lactating women.
• Intestinal stoma, cardiac disease, previous craniotomy for brain tumor resection, or intracranial infection.
• 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.
• Unable to undergo MRI or EEG examination.
• Deemed unsuitable for participation by the investigator.
• Participation in another drug or device clinical trial within the past 3 months.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

Location

MeSH Terms

Interventions

Levetiracetam

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wang Dr.Jia

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Xiu Dong Dr.Guan, MD

CONTACT

+86-18801075852; jwttyy@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

CN (1)