Comparing short and long-term use of levetiracetam for seizures in brain tumor patients
Official title: Short Versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)
Run by Tata Memorial Centre · NCT06442748 · Data updated 2026-11-12
This study tests whether taking levetiracetam for a shorter time can help brain tumor patients with seizures just as well as the standard longer treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 604 (estimated) |
| Sponsor | Tata Memorial Centre Academic / other |
| Locations | 2 sites (Udupi, Karnataka and 1 other locations) |
| Status | Recruiting |
| Started | July 4, 2024 |
| Main results expected | June 1, 2031 |
| Study ends | June 1, 2031 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT06442748 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years with a primary brain tumor in the supratentorial region, who have been seizure-free on levetiracetam for at least six months.
✕Probably not a fit
Patients with a Karnofsky Performance Scale score below 50 or those with progressive disease or brain metastasis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the optimal duration of levetiracetam treatment for patients with brain tumors who have a history of seizures. Participants will be randomized into two groups: one receiving a standard long-term treatment for two years and the other receiving a shorter tapering regimen. The study aims to determine if a shorter course of levetiracetam can maintain seizure control without increasing the risk of seizure recurrence. Follow-up assessments will include quality of life evaluations and neuroimaging to monitor tumor status.
Why it matters
Potential benefit: If successful, this study could lead to a more tailored approach in managing seizures for brain tumor patients, potentially reducing unnecessary medication exposure and side effects.
How similar studies have gone: While the approach of optimizing treatment duration is common, this specific comparison of short versus long-term levetiracetam use in this patient population is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Tata Memorial Centre
Mumbai, Maharashtra, India Recruiting -
Manipal Academy of Higher Education
Udupi, Karnataka, India Not yet recruiting
Study contacts
- Principal investigator: Archya Dasgupta — Tata Memorial Centre Mumbai
- Study coordinator: Archya Dasgupta, MD
- Email: archya1010@gmail.com
- Phone: 02224177000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.