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Levetiracetam Prophylaxis in Brain Tumor Resection Pilot (LeviTaTe Pilot)

Primary Purpose

Seizures, Brain Tumor

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levetiracetam
Placebo
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seizures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult age 18 years or older Undergoing craniotomy for a brain tumor Intra-axial tumor location Supratentorial tumor location Exclusion Criteria: Documented seizure history or epilepsy diagnosis Currently taking an antiepileptic medication Unable to take levetiracetam (e.g. allergy, inability to swallow) Inability to obtain consent from participant or substitute decision maker prior to surgery Renal impairment with eGFR less than 50 Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Seizure Prophylaxis (Levetiracetam)

    Placebo

    Arm Description

    Levetiracetam 1 g taken orally twice a day for 7 days

    Placebo taken orally twice a day for 7 days

    Outcomes

    Primary Outcome Measures

    Recruitment Rate
    Feasibility outcome

    Secondary Outcome Measures

    Fraction of eligible patients approached
    Fraction of approached patients consent
    Role of individual who approached patients
    Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.)
    Protocol adherence
    Number of participants who withdrawal from the study
    Protocol adherence
    Drug adherence rate
    Protocol adherence
    Follow-up completion rate
    Protocol adherence
    Method of follow-up (e.g. telephone, clinic visit)
    Adverse events
    Serious and related adverse events and adverse drug reactions
    Unblinding events
    Number of events and reasoning

    Full Information

    First Posted
    April 4, 2023
    Last Updated
    September 20, 2023
    Sponsor
    Hamilton Health Sciences Corporation
    Collaborators
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05897658
    Brief Title
    Levetiracetam Prophylaxis in Brain Tumor Resection Pilot
    Acronym
    LeviTaTe Pilot
    Official Title
    Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hamilton Health Sciences Corporation
    Collaborators
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate feasibility of a double-blind randomized controlled trial for levetiracetam prophylaxis for prevention of seizure in the perioperative phase of brain tumor resection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Seizures, Brain Tumor

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Seizure Prophylaxis (Levetiracetam)
    Arm Type
    Experimental
    Arm Description
    Levetiracetam 1 g taken orally twice a day for 7 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo taken orally twice a day for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Levetiracetam
    Intervention Description
    Tablets
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Tablets
    Primary Outcome Measure Information:
    Title
    Recruitment Rate
    Description
    Feasibility outcome
    Time Frame
    Through study completion, approximately 1 year
    Secondary Outcome Measure Information:
    Title
    Fraction of eligible patients approached
    Time Frame
    Through study completion, approximately 1 year
    Title
    Fraction of approached patients consent
    Time Frame
    Through study completion, approximately 1 year
    Title
    Role of individual who approached patients
    Description
    Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.)
    Time Frame
    Through study completion, approximately 1 year
    Title
    Protocol adherence
    Description
    Number of participants who withdrawal from the study
    Time Frame
    Through study completion, approximately 1 year
    Title
    Protocol adherence
    Description
    Drug adherence rate
    Time Frame
    Through study completion, approximately 1 year
    Title
    Protocol adherence
    Description
    Follow-up completion rate
    Time Frame
    Through study completion, approximately 1 year
    Title
    Protocol adherence
    Description
    Method of follow-up (e.g. telephone, clinic visit)
    Time Frame
    Through study completion, approximately 1 year
    Title
    Adverse events
    Description
    Serious and related adverse events and adverse drug reactions
    Time Frame
    Through study completion, approximately 1 year
    Title
    Unblinding events
    Description
    Number of events and reasoning
    Time Frame
    Through study completion, approximately 1 year
    Other Pre-specified Outcome Measures:
    Title
    New onset seizure within 7 days of surgery
    Time Frame
    7 days post-surgery, reviewed at follow-up between post-operative day 8 and 14
    Title
    Incidence of infection during Study Drug administration
    Time Frame
    Follow-up between post-operative day 8 and 14
    Title
    Incidence of psychiatric symptoms during Study Drug Administration
    Time Frame
    Follow-up between post-operative day 8 and 14
    Title
    Length of hospital stay in days
    Time Frame
    Hospital discharge
    Title
    Incidence of administration of any antiepileptic drugs
    Time Frame
    Follow-up between post-operative day 8 and 14
    Title
    Incidence of administration of any benzodiazepines
    Time Frame
    Follow-up between post-operative day 8 and 14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult age 18 years or older Undergoing craniotomy for a brain tumor Intra-axial tumor location Supratentorial tumor location Exclusion Criteria: Documented seizure history or epilepsy diagnosis Currently taking an antiepileptic medication Unable to take levetiracetam (e.g. allergy, inability to swallow) Inability to obtain consent from participant or substitute decision maker prior to surgery Renal impairment with eGFR less than 50 Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Taylor Duda, MD
    Phone
    905-521-2100
    Ext
    44155
    Email
    taylor.duda@medportal.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amanda Martyniuk, MSc
    Phone
    905-521-2100
    Ext
    44155
    Email
    martynia@mcmaster.ca

    12. IPD Sharing Statement

    Learn more about this trial

    Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

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