Short Versus Long-term Levetiracetam in Brain Tumors

NCT06442748 | Recruiting Phase 3 DMC

• 1 other identifier: 4385
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Seizures; Brain Tumors; Antiepileptics; Levetiracetam

Outcome Measures

Primary Outcomes (1)

• 2-year seizure free survival

  Seizure-free survival measured using Kaplan-Meier product limit method survival calculated from the time of randomization.

  7 year

Secondary Outcomes (6)

• Overall survival

  7 year

• Progression-free survival

  7 year

• Cost-benefit analysis Cost-benefit analysis

  7 year

• Quality of life core questionnaire

  7 year

• Quality of life brain cancer module

  7 year

Study Arms (2)

STANDARD

OTHER

In the standard arm, patients will continue on the same dose and schedule of levetiracetam (prescribed in the range of 1000-3000 mg/ day in 2-3 divided doses) for a duration of 2 years.

Drug: Levetiracetam

EXPERIMENTAL

EXPERIMENTAL

In the experimental arm, levetiracetam will be tapered by 250- 500 mg every week and then stopped.

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

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.

EXPERIMENTAL; STANDARD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Centre: lead
• Manipal Academy for Higher Education: collaborator

Study Sites (2)

Manipal Academy of Higher Education

Udupi, Karnataka, 576104, India

NOT YET RECRUITING

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Seizures; Brain Neoplasms

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Archya Dasgupta

  Tata Memorial Centre Mumbai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Archya Dasgupta, MD

CONTACT

02224177000; archya1010@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Radiation Oncology

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 4, 2024
• Study Start: July 4, 2024
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

IN (2)