Clinical trial · Interventional
Short Versus Long-term Levetiracetam in Brain Tumors
Short Versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Levetiracetam is the commonly preferred anti-seizure medicine in patients with brain tumors. This drug has reduced the risk of seizure events occurring but is associated with a risk of side effects such as increased headache, drowsiness, loss of muscle coordination, and psychological challenges in patients. In patients undergoing appropriate treatment for brain tumors and controlled of seizures in the initial few months of levetiracetam, the chance of further seizures is relatively low. The optimal duration to give levetiracetam is not well defined for these patients, and currently as standard treatment levetiracetam is continued for 2-3 years. This study aims to answer this question by comparing patients on a short course of levetiracetam (experimental arm) versus a longer course of levetiracetam (standard arm), with the anticipation that a shorter duration of treatment will not lead to increased seizure episodes.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antiepileptics | — | UNRESOLVED | — |
| Brain Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Levetiracetam | — | UNRESOLVED | — |
| Seizures | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levetiracetam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- STANDARD
- description
- In the standard arm, patients will continue on the same dose and schedule of levetiracetam (prescribed in the range of 1000-3000 mg/ day in 2-3 divided doses) for a duration of 2 years.
- interventionNames
- Drug: Levetiracetam
- type
- EXPERIMENTAL
- label
- EXPERIMENTAL
- description
- In the experimental arm, levetiracetam will be tapered by 250- 500 mg every week and then stopped.
- interventionNames
- Drug: Levetiracetam
Primary outcomes (1)
- measure
- 2-year seizure free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (28)
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- BACKGROUNDHildebrand J, Lecaille C, Perennes J, Delattre JY. Epileptic seizures during follow-up of patients treated for primary brain tumors. Neurology. 2005 Jul 26;65(2):212-5. doi: 10.1212/01.wnl.0000168903.09277.8f. PMID 16043788
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