Seizure Prophylaxis in Patients With Glioma or Brain Metastasis
Condition: Glioma; Glioma of Brain; Brain Tumor
MeSH terms: Glioma; Brain Neoplasms; Seizures
Intervention: Lacosamide; Levetiracetam
Intervention description: LCM 100mg twice a day.; LEV 1000mg twice a day.
Intervention MeSH terms: Lacosamide; Levetiracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: anti-epileptic drugs; seizure prophylaxis; levetiracetam

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a suspected diagnosis of new, recurrent, or transformed glioma (WHO
             grade I-IV) or brain metastasis scheduled for neurosurgical procedure (gross-total
             resection, sub-total resection or biopsy) at Duke University Medical Center (DUMC);

          2. Safe for surgery per treating neurosurgeon;

          3. Due to the potential implications of the treatment on the developing central nervous
             system (CNS), all patients must be ≥ 18 years of age at the time of entry into the
             study;

          4. Laboratory Studies:

               1. Total bilirubin, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic
                  Pyruvic Transaminase (SGPT), Alkaline Phosphatase (ALK) ≤ 1.5 x upper limit of
                  normal (ULN)

               2. Creatinine ≤ 1.5

          5. A signed informed consent form approved by the Duke University Institutional Review
             Board (IRB) will be required for patient enrollment into the study. Patients must be
             able to read and understand the informed consent document and must sign the informed
             consent indicating that they are aware of the investigational nature of this study.

          6. Patients of child bearing potential or with partners of child-bearing potential must
             agree to practice recommended contraceptive methods to prevent pregnancy during
             treatment and for 1 month after the last dose of AED for women and men.

        Exclusion Criteria:

          1. Pregnant or need to breast feed during the study period (Negative urine β-human
             chorionic gonadotropin (HCG) test required), or unable to maintain use of
             contraception while on study and for 1 month after the last dose of AED;

          2. Patients already on AED(s);

          3. Known history of epilepsy/seizure disorder;

          4. Known history of dependency/abuse of psychopharmaceuticals, alcohol, illicit drugs or
             narcotics;

          5. Any significant medical or psychiatric illness that cannot be adequately controlled
             with appropriate therapy or would compromise the patient's ability to tolerate
             therapy, per the discretion of the treating investigator;

          6. Known allergy to LCM or LEV.