RecruitingPhase 3NCT06442748

Short Versus Long-term Levetiracetam in Brain Tumors

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


Sponsor

Tata Memorial Centre

Enrollment

604 participants

Start Date

Jul 4, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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

Interventions

DRUGLevetiracetam

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.


Locations(2)

Manipal Academy of Higher Education

Udupi, Karnataka, India

Tata Memorial Centre

Mumbai, Maharashtra, India

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