Short Versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Tata Memorial Centre
RECRUITING
Mumbai
Contact Information
Primary
Archya Dasgupta, MD
archya1010@gmail.com
02224177000
Time Frame
Start Date: 2024-07-04
Estimated Completion Date: 2031-06-01
Participants
Target number of participants: 604
Treatments
Other: 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.
Experimental: EXPERIMENTAL
In the experimental arm, levetiracetam will be tapered by 250- 500 mg every week and then stopped.
Related Therapeutic Areas
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov