NCT07239115 Levetiracetam for Seizure Prevention After Brain Tumor Surgery
| NCT ID | NCT07239115 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Postoperative Seizures After Brain Tumor Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 558 participants |
| Start Date | 2026-05-14 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 558 participants in total. It began in 2026-05-14 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Wang Dr.Jia
STUDY CHAIR
Beijing Tiantan Hospital
Frequently Asked Questions
Who can join the NCT07239115 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Postoperative Seizures After Brain Tumor Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07239115 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 558 participants.
Is NCT07239115 currently recruiting?
Yes, NCT07239115 is actively recruiting participants. Contact the research team at jwttyy@126.com for enrollment information.
Where is the NCT07239115 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07239115 clinical trial?
NCT07239115 is sponsored by Beijing Tiantan Hospital. The principal investigator is Wang Dr.Jia at Beijing Tiantan Hospital. The trial plans to enroll 558 participants.