CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 604 target
Drug / intervention
Levetiracetamdrug
Likely dose
Not stated in record
Key inclusion· 7
  • Age 18 years or older
  • History of seizure
  • Histologically confirmed primary brain tumor
  • Supratentorial tumor location
Key exclusion· 8
  • KPS less than 50
  • No history of seizure
  • Unclear history of seizure episodes
  • Use of antiepileptics other than levetiracetam in previous 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06442748
NCT06442748Phase 3RecruitingOn TrackUpdated 4mo ago

Short Versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)

Tata Memorial Centre·interventional·Posted Jun 4, 2024·Updated Feb 13, 2026

In Brief

A Phase 3 clinical trial evaluating Levetiracetam for Seizures and 3 related conditions. Currently recruiting, targeting 604 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia

Timeline

Phase 3Recruiting
2025202620272028202920302031
First PostedJun 4, 2024
Enrollment StartJul 4, 2024
Primary CompletionJun 1, 2031
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 2.1 years agoPrimary completion in 4.9 years

Interventions

Levetiracetamdrug

Levetiracetam is usually preferred in brain tumor-related epilepsy. Levetiracetam is a second-generation antiepileptic drug that binds to synaptic vesicle glycoprotein SV2A, which interferes with the release of neurotransmitters from the synaptic vesicle and control seizure by multiple mechanisms.