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

Seizures Brain Tumors Antiepileptics Levetiracetam

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

Plain Language Summary

Simplified for easier understanding

This study looks at whether people with brain tumors who have been seizure-free on a single anti-seizure medication (levetiracetam) for 6 months can safely reduce or stop that medication — balancing the risk of seizures returning against the side effects and burden of long-term medication use. **You may be eligible if...** - You are 18 years old or older - You have a primary brain tumor located in the upper part of the brain (supratentorial) - You have a history of seizures related to your brain tumor - You have been well-controlled on levetiracetam alone for at least 6 months - Your index surgery was within the past year - You have a Karnofsky score of 50 or above (able to care for some personal needs) **You may NOT be eligible if...** - You have never had a seizure - You are taking more than one seizure medication - Your Karnofsky score is below 50 (significantly limited in self-care) - Your seizure history is unclear Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.