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NCT Number: NCT05897658

Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

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.

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Key information

Conditions

Seizures Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levetiracetam

Drug

Tablets

Placebo

Other

Tablets

Primary outcomes

  1. Recruitment Rate

    Time frame: Through study completion, approximately 1 year

    Feasibility outcome

Secondary outcomes

  1. Fraction of eligible patients approached

    Time frame: Through study completion, approximately 1 year

  2. Fraction of approached patients consent

    Time frame: Through study completion, approximately 1 year

  3. Role of individual who approached patients

    Time frame: Through study completion, approximately 1 year

    Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.)

  4. Protocol adherence

    Time frame: Through study completion, approximately 1 year

    Number of participants who withdrawal from the study

  5. Protocol adherence

    Time frame: Through study completion, approximately 1 year

    Drug adherence rate

  6. Protocol adherence

    Time frame: Through study completion, approximately 1 year

    Follow-up completion rate

  7. Protocol adherence

    Time frame: Through study completion, approximately 1 year

    Method of follow-up (e.g. telephone, clinic visit)

  8. Adverse events

    Time frame: Through study completion, approximately 1 year

    Serious and related adverse events and adverse drug reactions

  9. Unblinding events

    Time frame: Through study completion, approximately 1 year

    Number of events and reasoning

Other outcomes

  1. 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

  2. Incidence of infection during Study Drug administration

    Time frame: Follow-up between post-operative day 8 and 14

  3. Incidence of psychiatric symptoms during Study Drug Administration

    Time frame: Follow-up between post-operative day 8 and 14

  4. Length of hospital stay in days

    Time frame: Hospital discharge

  5. Incidence of administration of any antiepileptic drugs

    Time frame: Follow-up between post-operative day 8 and 14

  6. Incidence of administration of any benzodiazepines

    Time frame: Follow-up between post-operative day 8 and 14

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Martyniuk, MSc

CONTACT

[email protected]

905-521-2100 ext. 44155

Taylor Duda, MD

CONTACT

[email protected]

905-521-2100 ext. 44155

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • McMaster University

Registry information

Official study title

Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection

Acronym: LeviTaTe Pilot

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2023
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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