Short Versus Long-term Levetiracetam in Brain Tumors

NCT ID: NCT06442748

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 604 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-04
• Study Completion Date: 2031-06-01

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.

Detailed Description

Patients with prior history of seizure from primary brain tumor in the supratentorial location with controlled seizure on levetiracetam monotherapy for at least six months will be considered for the study. Patients more than 18 years of age with KPS ≥ 50 will be eligible. Patients will be randomized in one of the two arms (standard arm or experimental arm) in a 1:1 ratio and stratified based on seizure type, location, histology, tumor grade, and adjuvant therapy. Randomization will be done by the statistician via computerized software using a permuted block design. In the standard arm, patients will continue on the same dose and schedule of levetiracetam (typically prescribed in the range of 1000-3000 mg/ day in 2-3 divided doses) for a duration of 2 years. In the experimental arm, levetiracetam will be tapered by 250- 500 mg every week and stopped. Follow-ups will be done every 3-6 months as per standard practice for the given tumor histology. Neuroimaging will be done 6-12 monthly as per routine clinical practice. The quality-of-life assessment will be done every six months. The primary endpoint is 2-year seizure free survival calculated from the time of randomization.

Patients will continue to receive standard treatment, including adjuvant therapy as standard practice. In case in either arm, the patient develops a seizure episode after stopping levetiracetam will be restarted on levetiracetam monotherapy. If a patient develops a seizure episode while on levetiracetam monotherapy, further add-on antiepileptics will be considered as per standard practice by the responsible physician. Any complications arising from previous treatments (e.g., radio necrosis) or recurrent disease during the study period will be managed according to standard institutional practice without any influence of the study.

The study will be conducted at Tata Memorial Centre with a total sample size of 604 patients for a duration of seven years.

Conditions

Seizures; Brain Tumors; Antiepileptics; Levetiracetam

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STANDARD

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.

Group Type: OTHER

Levetiracetam

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Levetiracetam

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr Archya Dasgupta

Assistant Professor, Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Archya Dasgupta

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Centre Mumbai

Locations

Tata Memorial Centre

Mumbai, Maharashtra, India

Site Status: RECRUITING

Countries

India

Central Contacts

Archya Dasgupta, MD

Role: CONTACT

archya1010@gmail.com

02224177000 ext. 6861

Facility Contacts

Archya Dasgupta

Role: primary

archya1010@gmail.com

02224177000 ext. 6861

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Other Identifiers

4385

Identifier Type: -

Identifier Source: org_study_id