SeizuresPhase 3LeviTaTe PilotNCT05897658
Levetiracetam Prophylaxis in Brain Tumor Resection Pilot
A Phase 3 study testing Levetiracetam in people with Seizures and Brain Tumor, run by Hamilton Health Sciences Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seizures, Brain Tumor
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult age 18 years or older
- Undergoing craniotomy for a brain tumor
- Intra-axial tumor location
- Supratentorial tumor location
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection
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.
- Conditions
- Seizures, Brain Tumor
- Being tested
- Levetiracetam, Placebo
- Medical subject headings
- Seizures, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Tablets
PlaceboOther
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Seizure Prophylaxis (Levetiracetam) | Experimental | Levetiracetam 1 g taken orally twice a day for 7 days Receives: Drug: Levetiracetam |
| Placebo | Placebo comparator | Placebo taken orally twice a day for 7 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Feasibility outcome
Measured: Through study completion, approximately 1 year
Secondary outcomes (9)
Fraction of eligible patients approached
Measured: Through study completion, approximately 1 year
Fraction of approached patients consent
Measured: Through study completion, approximately 1 year
Role of individual who approached patients
Description of research team member first approaching and consenting patients (e.g. resident, research staff, staff surgeon, etc.)
Measured: Through study completion, approximately 1 year
Protocol adherence
Number of participants who withdrawal from the study
Measured: Through study completion, approximately 1 year
Protocol adherence
Drug adherence rate
Measured: Through study completion, approximately 1 year
Protocol adherence
Follow-up completion rate
Measured: Through study completion, approximately 1 year
Protocol adherence
Method of follow-up (e.g. telephone, clinic visit)
Measured: Through study completion, approximately 1 year
Adverse events
Serious and related adverse events and adverse drug reactions
Measured: Through study completion, approximately 1 year
Unblinding events
Number of events and reasoning
Measured: Through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897658
- Sponsor's protocol ID
- 14147
- Acronym
- LeviTaTe Pilot
- Status last verified
- Oct 2024
- First submitted
- 4 Apr 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Levetiracetam Prophylaxis Randomized Controlled Trial in Brain Tumor Resection
- ClinicalTrials.gov ID
- NCT05897658
- Acronym / sponsor ID
- LeviTaTe Pilot / 14147
- Conditions
- Seizures, Brain Tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seizure Prophylaxis (Levetiracetam) | Experimental | Drug: LevetiracetamLevetiracetam 1 g taken orally twice a day for 7 days |
| Placebo | Placebo comparator | Other: PlaceboPlacebo taken orally twice a day for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult age 18 years or older
- Undergoing craniotomy for a brain tumor
- Intra-axial tumor location
- Supratentorial tumor location
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamTablets | Drug | Seizure Prophylaxis (Levetiracetam) |
| PlaceboTablets | Other | Placebo |
Primary outcome
Recruitment Rate
Time frame: Through study completion, approximately 1 year
Feasibility outcome
9 secondary outcomes
Fraction of eligible patients approached
Time frame: Through study completion, approximately 1 year
Fraction of approached patients consent
Time frame: Through study completion, approximately 1 year
Role of individual who approached patients
Time frame: Through study completion, approximately 1 year
Protocol adherence
Time frame: Through study completion, approximately 1 year
Protocol adherence
Time frame: Through study completion, approximately 1 year
Protocol adherence
Time frame: Through study completion, approximately 1 year
Protocol adherence
Time frame: Through study completion, approximately 1 year
Adverse events
Time frame: Through study completion, approximately 1 year
Unblinding events
Time frame: Through study completion, approximately 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Seizures
Not yet recruitingPhase 1
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults
Focal Onset Seizure
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
Not yet recruitingPhase 3
Open-label, Single-arm Trial of Ganaxolone in CDD Patients 6 Months to Less Than 2 Years Old
CDKL5 Deficiency Disorder
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam in people with Seizures and Brain Tumor, run by Hamilton Health Sciences Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taylor Duda, MD (905-521-2100 ext. 44155, taylor.duda@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Through study completion, approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.