Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Glioma

Brain Neoplasms

Neoplasm Metastasis

Epilepsy

Seizures

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neurologic Manifestations

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Anticonvulsants

Nootropic Agents

All Drugs and Chemicals

Channel Blockers

Levetiracetam

Lacosamide

Sodium Channel Blockers

Diuretics, Potassium Sparing

Enrolled subjects will be randomized to receive Lacosamide.

Enrolled subjects will be randomized to receive Levetiracetam.

Enrolled subjects will be randomized to not receive anti-epileptic drugs.

Annick Desjardins, M.D.

This protocol is designed to assess the need for seizure prophylaxis in the perioperative period for patients undergoing neurosurgical procedure (gross-total resection, sub-total resection or biopsy) for suspected diagnosis of new, recurrent or transformed glioma (WHO grade I-IV) and brain metastasis. This will be determined by observing the impact of Lacosamide (LCM), Levetiracetam (LEV), or no anti-epileptic drug (AED) on whether visits to the emergency department (ED) or hospital re-admissions occur within 30 days after procedure. A secondary endpoint will evaluate the safety and tolerability of LCM and LEV. Exploratory endpoints will evaluate admission duration for the procedure, number of post-operative provider communications (telephone, email, and additional clinic encounters, etc.), and patient risk factors associated with post-operative seizure.

The protocol will assess the need for AED prophylaxis during the post-operative period in patients undergoing neurosurgical procedure for a suspected diagnosis of glioma (WHO grade I-IV) and brain metastasis. Patients (n=116) will be consented and randomized at their pre-operative assessment, either at their pre-operative clinic visit or in the ED, if that is the time of their initial presentation prior to surgery. There will be three arms to the study - patients will be randomized to LCM, LEV, or control (no AED). Randomization will be stratified by suspected grade (LGG vs HGG) and brain metastasis. The AED can be initiated anytime within 48 hours before neurosurgical procedure.

Doses will be either LCM 100mg twice a day (BID) (Arm A), LEV 1000mg BID (Arm B), or no AED (Arm C). If a patient is randomized to Arm C and undergoes tumor mapping, the patient is allowed to receive one dose of AED in the operating room. If a patient is randomized to Arm A or Arm B and takes the morning dose of their AED, they do not need an intra-operative dose of AED. If a patient has a seizure during the post-operative period, AEDs will be adjusted at the discretion of the treating physician. However, if a patient has intolerable side effects, patients will be changed to a different dose of the same medicine before consideration of another AED \[i.e., BID to four times a day (QID) dosing if patient experiences diplopia on LCM\].

Patients with high-grade tumors (newly-diagnosed or transformed) will be treated with standard radiation and temozolomide therapy per the Stupp protocol 25,70. For these patients, an AED taper will be initiated at the first clinic visit after completion of radiation. For patients with a low-grade tumor or recurrent disease of any grade or brain metastasis, an AED taper will be initiated at the first scheduled post-operative visit, approximately 6-10 weeks after the operation. LCM will be tapered by 100mg a week one week at a time. LEV will be tapered 500-1000mg one week at a time.

Upon consent, patients will be randomized in REDCap™ to receive either LCM, LEV, or no AED. Randomization will be stratified by suspected histologic grade (LGG vs HGG vs brain metastasis) based on MRI review by the treating neurosurgeon and/or neuro-oncologist. A stratified permuted block randomization algorithm will be used assign patients to treatment arms.

Seizure Prophylaxis in Patients With Glioma or Brain Metastasis

Phase II Trial of Seizure Prophylaxis in Brain Tumor Patients Undergoing Neurosurgical Procedure

The primary objective of this study is to assess the impact of LCM, LEV or, no AED in patients undergoing craniotomy for suspected new, recurrent or transformed glioma (WHO Gr I-IV) or brain metastasis on ED visits and readmissions within 30 days of craniotomy.

Adverse events related to LCM, LEV, and no drug within first 30 days after craniotomy.

Duke University

Enrolled subjects will be randomized to receive Lacosamide.

Lacosamide: LCM 100mg twice a day.

Enrolled subjects will be randomized to receive Levetiracetam.

Levetiracetam: LEV 1000mg twice a day.

No Anti-epileptic

Total

Age, Continuous

Sex: Female, Male

Race

Race/Ethnicity, Customized

United States

Region of Enrollment

Anxiety

This study was limited by the small sample size, and a dataset with a larger sample size should be used to further evaluate the impact of LCM, LEV, and no antiepileptic drugs on adverse events, ED visits and hospital readmissions in the future.

Claudia E. Pamanes, MPH, CCRP

Percentage of Patients With an ED Visit/Hospital Readmission Within 30 Days of Craniotomy

Dizziness

Somnolence

Cognitive disturbance

Nausea

Vomiting

Ataxia

Suicide thought

Suicide attempt

Depression

Irritability

Psychosis

Personality change

Number of Participants With an Adverse Event Within First 30 Days After Craniotomy

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Seizure Prophylaxis in Patients With Glioma or Brain Metastasis	NCT03436433	Glioma Glioma of Brain Brain Tumor	Lacosamide Levetiracetam	18 Years - 99 Years	Duke University
Seizure Prophylaxis in Patients With Glioma or Brain Metastasis	NCT03436433	Glioma Glioma of Brain Brain Tumor	Lacosamide Levetiracetam	18 Years - 99 Years	Duke University

Spots Global Cancer Trial Database for seizure prophylaxis