Could brain tumor patients stop seizure meds sooner?
NCT ID NCT06442748
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether brain tumor patients who have been seizure-free for 6 months on levetiracetam can safely stop the drug earlier than the standard 2-3 years. 604 adults with primary brain tumors and controlled seizures will be randomly assigned to stop levetiracetam after 6 months or continue for 2-3 years. The goal is to see if a shorter course prevents seizures just as well while reducing side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- levetiracetam
- What this could lead to
- If successful, this could show that a shorter course of levetiracetam is just as effective as a longer one, reducing side effects and medication burden for brain tumor patients.
- What could go wrong
- This is a large phase 3 trial, but it is still possible that stopping levetiracetam early leads to more seizures. The results may not apply to all brain tumor types or patients on other medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 604 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jun 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: • Age ≥ 18years * History of seizure * Histological diagnosis of primary brain tumor * Supratentorial location of primary tumor * Controlled on levetiracetam monotherapy for 6 months * Index surgery within 1 year * Karnofsky Performance Scale (KPS) ≥ 50 Exclusion Criteria: * KPS \< 50 * No history of seizure * Unclear history of seizure episodes in the past * Use of antiepileptics other than levetiracetam in the previous 6 months * No histological diagnosis * Progressive disease * Brain metastasis * Altered mental status with deficits in understanding or inability to consent to the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Manipal Academy of Higher Education
NOT_YET_RECRUITINGUdupi, Karnataka, 576104, India
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Tata Memorial Centre
RECRUITINGMumbai, Maharashtra, 400012, India
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