Seizure Prophylaxis in Patients With Glioma or Brain Metastasis

NCT03436433 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: Pro00081334
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma; Glioma of Brain; Brain Tumor

Keywords

anti-epileptic drugs; seizure prophylaxis; levetiracetam

Outcome Measures

Primary Outcomes (1)

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

  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.

  30 days following surgery

Secondary Outcomes (1)

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

  30 days following surgery

Study Arms (3)

Lacosamide

ACTIVE COMPARATOR

Enrolled subjects will be randomized to receive Lacosamide.

Drug: Lacosamide

Levetiracetam

ACTIVE COMPARATOR

Enrolled subjects will be randomized to receive Levetiracetam.

Drug: Levetiracetam

No anti-epileptic

NO INTERVENTION

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

Interventions

Lacosamide DRUG

LCM 100mg twice a day.

Also known as: LCM, Vimpat

Lacosamide

Levetiracetam DRUG

LEV 1000mg twice a day.

Also known as: LEV, Keppra

Levetiracetam

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Safe for surgery per treating neurosurgeon;
• 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;
• Laboratory Studies:
• Total bilirubin, Serum Glutamic Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT), Alkaline Phosphatase (ALK) ≤ 1.5 x upper limit of normal (ULN)
• Creatinine ≤ 1.5
• 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.
• 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.

You may not qualify if:

• 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;
• Patients already on AED(s);
• Known history of epilepsy/seizure disorder;
• Known history of dependency/abuse of psychopharmaceuticals, alcohol, illicit drugs or narcotics;
• 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;
• Known allergy to LCM or LEV.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Interventions

Lacosamide; Levetiracetam

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

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.

Results Point of Contact

• Title: Claudia E. Pamanes, MPH, CCRP
• Organization: Duke Neurosugery

claudia.pamanes@duke.edu

9196680897

Study Officials

• Annick Desjardins, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: January 31, 2019
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: April 13, 2023
• Results First Posted: December 30, 2021

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)