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Short Versus Long-term Levetiracetam in Brain Tumors

Study acronym: LIBRA
StatusRecruiting
PhasePhase 3
Started2024-07-04
View on ClinicalTrials.gov ↗

Amendment history

2026-02-11
minor
Study Status, Study Description, Outcome Measures, Contacts/Locations v5
Study sites1→2
Secondary endpoints5 to 6 entries
Seizure-free survival between two arms using death as a competing risk
Study description+599 characters
[...] institutional practice without any influence of the study. An interim analysis is planned for harm or futility to stop the trial when quarter of the expected events have occurred (25% information time), if the observed HR is equal to or greater than the non-inferiority margin (1.47). At the interim analysis, the one-sided P-value is calculated for testing t [...] The study will be conducted at Tata Memorial Centre and Manipal Academy of Higher Education with a total sample size of 604 patients for a duration of seven years.
2026-02-02
minor
Study Status, Sponsor/Collaborators v4
Collaborators+36 characters
Manipal Academy for Higher Education
2024-11-18
minor
Study Status v3
Re-verified, no change to tracked fields
2024-07-08
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-07-01→confirmed 2024-07-04
Study sites0→1
2024-06-27
minor
Study Status v1
Start date2024-06-01→2024-07-01
2024-05-29
minor
Original filing
723 trials monitored
See 41 trials at risk
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.
Trial Details
NCT Number NCT06442748
Lead Sponsor Tata Memorial Centre
Collaborators: Manipal Academy for Higher Education
Conditions Seizures, Brain Tumors, Antiepileptics, Levetiracetam
Enrollment 604 participants
Start Date 2024-07-04
Primary Completion 2031-06-01 (estimated)
Study Completion 2031-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-13