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Clinical Trials in India / NCT06442748
Recruiting Phase 3

Short Versus Long-term Levetiracetam in Brain Tumors

NCT06442748 · tracked via the Priya Life Science India tracker
Sponsor
Tata Memorial Centre
Phase
Phase 3
Started
2024-07-04
Last updated
2026-02-13

Condition(s) studied

SeizuresBrain TumorsAntiepilepticsLevetiracetam

Investigational drug(s) / intervention(s)

Levetiracetam

Levetiracetam: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: • Age ≥ 18years * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Manipal Academy of Higher Education Udupi Karnataka Not Yet Recruiting
Tata Memorial Centre Mumbai Maharashtra Recruiting

On this site

📄 Keppra (levetiracetam) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06442748 on ClinicalTrials.gov ↗ ← All trials in India