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Seizure Prophylaxis Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03436433
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioma Glioma of Brain Brain Tumor Drug: Lacosamide Drug: Levetiracetam Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
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)
Primary Purpose: Treatment
Official Title: Phase II Trial of Seizure Prophylaxis in Brain Tumor Patients Undergoing Neurosurgical Procedure
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lacosamide
Enrolled subjects will be randomized to receive Lacosamide.
 Drug: Lacosamide
LCM 100mg twice a day.
Other Names:
  • LCM
  • Vimpat
Active Comparator: Levetiracetam
Enrolled subjects will be randomized to receive Levetiracetam.
 Drug: Levetiracetam
LEV 1000mg twice a day.
Other Names:
  • LEV
  • Keppra
No Intervention: No anti-epileptic
Enrolled subjects will be randomized to not receive anti-epileptic drugs.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with an ED visit/hospital readmission within 30 days of craniotomy [ Time Frame: 30 days following surgery ]
    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.


Secondary Outcome Measures :
  1. Adverse event within first 30 days after craniotomy [ Time Frame: 30 days following surgery ]
    Adverse events related to LCM and LEV.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436433


Contacts
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Contact: Claudia Pamanes 919-668-0897 claudia.pamanes@duke.edu
Contact: Alexia Bwensa 919-681-5484 alexia.bwensa@duke.edu

Locations
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United States, North Carolina
Duke Comprehensive Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center    888-275-3853      
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Annick Desjardins, M.D. Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03436433    
Other Study ID Numbers: Pro00081334
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
anti-epileptic drugs
seizure prophylaxis
levetiracetam
Additional relevant MeSH terms:
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Glioma
Brain Neoplasms
Seizures
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Lacosamide
Levetiracetam
Anticonvulsants
Nootropic Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action