Postoperative Seizures After Brain Tumor SurgeryPhase 3PREVENTNCT07239115
Levetiracetam for Seizure Prevention After Brain Tumor Surgery
A Phase 3 study testing Levetiracetam in people with Postoperative Seizures After Brain Tumor Surgery, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Seizures After Brain Tumor Surgery
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 558 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2026to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Xiu Dong Dr.Guan, MD, +86 18801075852, jwttyy@126.com
About this study
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
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.
Read the detailed description
Seizures are a common complication in brain tumor patients, particularly after supratentorial craniotomy, with approximately two-thirds occurring within the first postoperative month and affecting both early recovery and long-term outcomes. Although prophylactic ASMs are widely used in practice, there is no consensus on whether routine prophylaxis is necessary or on the optimal regimen. Major societies generally conclude that evidence is insufficient to recommend for or against routine use, while some national guidance provides conditional suggestions only for "high-risk" patients-highlighting the lack of robust data. Real-world studies also show high but heterogeneous use and no unified standard. A high-quality randomized trial is therefore required to determine the necessity, efficacy, and safety of routine prophylaxis.
The PREVENT trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of levetiracetam in adults undergoing supratentorial tumor resection without a prior seizure history, and thereby to assess the need for routine perioperative prophylaxis. Participants are randomized 1:1 with center-stratified block allocation. The dosing regimen is: one intravenous dose 1 hour preoperatively and another on the evening after surgery, followed by oral/NG maintenance (0.5 g twice daily) through postoperative month 3; the control arm receives matching placebo. Standard antiseizure treatment is provided if seizures occur and these events are recorded as endpoints. Scheduled assessments occur at screening, day of surgery, postoperative day 7, month 3 (±7 days), and month 6 (±10 days).
The primary endpoint is clinical seizures within 3 months after surgery, adjudicated by predefined criteria. Secondary endpoints are subclinical seizures within 7 days and 3 months (based on standardized EEG review). Exploratory endpoints include direct medical costs and direct non-medical/indirect costs at 3 months, and clinical seizures within 6 months. Safety endpoints include adverse events, serious adverse events, and death through 3 months. The principal null hypothesis is no difference between groups. Efficacy is analyzed primarily in the full analysis set (FAS) with per-protocol (PPS) as supportive; center effects are modeled, two-sided α=0.05, and results reported as risk differences with 95% CIs and relative risks. The planned sample size is 558 participants across ~10 centers, with independent safety oversight. This trial will provide robust randomized evidence on the necessity, benefits, risks, and economic impact of routine perioperative prophylaxis to guide standardized clinical practice.
- Being tested
- Levetiracetam, Placebo
- Keywords
- Levetiracetam, Perioperative prophylaxis, Postoperative seizures, Tumor-related epilepsy, Antiseizure medication, PREVENT trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 90 days after surgery
Secondary outcomes (2)
Incidence of postoperative subclinical seizures detected by EEG
Occurrence of subclinical epileptiform discharges or electrographic seizures detected by scalp EEG within 7 days and 3 months postoperatively, without clinical seizure manifestations. Recordings will be reviewed and confirmed by independent neurophysiologists.
Measured: 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
Composite safety outcomes include the proportion of participants experiencing any adverse events (AEs), serious adverse events (SAEs), or all-cause mortality within 3 months postoperatively. AEs and SAEs will be coded using MedDRA and evaluated for severity and relationship to study drug according to ICH-GCP definitions.
Measured: Within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start14 May 2026
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Seizures After Brain Tumor SurgeryStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 558 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jia, Beijing Tiantan Hospital
- Investigators
- Wang Dr.Jia, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239115
- Sponsor's protocol ID
- KY2025-213-02
- Acronym
- PREVENT
- Status last verified
- May 2026
- First submitted
- 16 Nov 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07239115
- Acronym / sponsor ID
- PREVENT / KY2025-213-02
- Keywords
- Levetiracetam, Perioperative prophylaxis, Postoperative seizures, Tumor-related epilepsy, Antiseizure medication, PREVENT trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 558 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Seizures are a common complication in brain tumor patients, particularly after supratentorial craniotomy, with approximately two-thirds occurring within the first postoperative month and affecting both early recovery and long-term outcomes. Although prophylactic ASMs are widely used in practice, there is no consensus on whether routine prophylaxis is necessary or on the optimal regimen. Major societies generally conclude that evidence is insufficient to recommend for or against routine use, while some national guidance provides conditional suggestions only for "high-risk" patients-highlighting the lack of robust data. Real-world studies also show high but heterogeneous use and no unified standard. A high-quality randomized trial is therefore required to determine the necessity, efficacy, and safety of routine prophylaxis.
The PREVENT trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of levetiracetam in adults undergoing supratentorial tumor resection without a prior seizure history, and thereby to assess the need for routine perioperative prophylaxis. Participants are randomized 1:1 with center-stratified block allocation. The dosing regimen is: one intravenous dose 1 hour preoperatively and another on the evening after surgery, followed by oral/NG maintenance (0.5 g twice daily) through postoperative month 3; the control arm receives matching placebo. Standard antiseizure treatment is provided if seizures occur and these events are recorded as endpoints. Scheduled assessments occur at screening, day of surgery, postoperative day 7, month 3 (±7 days), and month 6 (±10 days).
The primary endpoint is clinical seizures within 3 months after surgery, adjudicated by predefined criteria. Secondary endpoints are subclinical seizures within 7 days and 3 months (based on standardized EEG review). Exploratory endpoints include direct medical costs and direct non-medical/indirect costs at 3 months, and clinical seizures within 6 months. Safety endpoints include adverse events, serious adverse events, and death through 3 months. The principal null hypothesis is no difference between groups. Efficacy is analyzed primarily in the full analysis set (FAS) with per-protocol (PPS) as supportive; center effects are modeled, two-sided α=0.05, and results reported as risk differences with 95% CIs and relative risks. The planned sample size is 558 participants across ~10 centers, with independent safety oversight. This trial will provide robust randomized evidence on the necessity, benefits, risks, and economic impact of routine perioperative prophylaxis to guide standardized clinical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam group | Experimental | Drug: LevetiracetamParticipants 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. |
| Placebo group | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamLevetiracetam 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. | Drug | Levetiracetam group |
| PlaceboMatching 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. | Drug | Placebo group |
Primary outcome
Incidence of postoperative clinical seizures within 90 days after surgery
Time frame: 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
2 secondary outcomes
Incidence of postoperative subclinical seizures detected by EEG
Time frame: 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
Time frame: Within 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wang Dr.Jia study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam in people with Postoperative Seizures After Brain Tumor Surgery, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiu Dong Dr.Guan, MD (+86-18801075852, jwttyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative clinical seizures within 90 days after surgery (time frame: Within 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.