Comparing short and long-term use of levetiracetam for seizures in brain tumor patients
Short Versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)
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 |
| Enrollment | 604 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Locations | 2 sites (Udupi, Karnataka and 1 other locations) |
| Trial ID | NCT06442748 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Udupi, Karnataka and 1 other locations
- Manipal Academy of Higher Education — Udupi, Karnataka, India (Not_yet_recruiting)
- Tata Memorial Centre — Mumbai, Maharashtra, India (Recruiting)
Study contacts
- Principal investigator: Archya Dasgupta — Tata Memorial Centre Mumbai
- Study coordinator: Archya Dasgupta, MD
- Email: archya1010@gmail.com
- Phone: 02224177000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.