Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442748
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-20
Brief Title:
Short Versus Long-term Levetiracetam in Brain Tumors
Sponsor:
Tata Memorial Centre
Organization:
Tata Memorial Centre
Study Overview
Official Title:
Short Versus Long-term Levetiracetam in Brain Tumors A Phase 3 Randomized Controlled Trial LIBRA
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIBRA
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 11 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None