Short Versus Long-term Levetiracetam in Brain Tumors

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTata Memorial Centre

About this trial

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 criteria

Qualifiers

History of seizure

Histological diagnosis of primary brain tumor

Supratentorial location of primary tumor

Controlled on levetiracetam monotherapy for 6 months

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Levetiracetam

Treatment groups

604 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tata Memorial Centre

Lead sponsor

Manipal Academy for Higher Education

Collaborator