Comparing Short and Long Term Levetiracetam Treatment in Adults with Brain Tumors and Controlled Seizures A Phase 3 Randomized Trial Evaluating Seizure Control and Safety

What this Trial Is About

Researchers are evaluating the optimal duration of levetiracetam treatment in patients with primary brain tumors who have experienced seizures. This phase 3 randomized controlled trial aims to compare a shorter course of levetiracetam with the current standard longer course. The goal is to determine whether stopping levetiracetam earlier will not lead to an increased risk of seizure episodes, while considering the side effects such as headache, drowsiness, muscle coordination loss, and psychological challenges commonly associated with this medication. Participants will be randomized into two groups the standard arm, where patients continue levetiracetam at the same dose typically 1000-3000 mg per day in divided doses for two years, and the experimental arm, where the drug is gradually reduced by 250-500 mg each week and then stopped. Follow-up visits will occur every 3 to 6 months, with routine neuroimaging done every 6 to 12 months according to tumor type. Quality of life assessments will be performed every six months. If seizures recur, levetiracetam or additional antiepileptic medications will be administered as needed per usual care. During the study, patients will continue standard treatments for their brain tumors, including any necessary adjuvant therapies. Researchers will monitor seizure-free survival over two years from randomization as the primary outcome. Secondary outcomes include overall survival, progression-free survival, cost-benefit analysis, and quality of life measures over seven years. The study includes safety monitoring through planned interim analyses and will enroll 604 patients over seven years at two centers.

Short Versus Long-term Levetiracetam in Brain Tumors