| CTRI Number |
CTRI/2024/06/069498 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Short versus Long-term Levetiracetam in Brain Tumors |
|
Scientific Title of Study
|
Short versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA) |
| Trial Acronym |
LIBRA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archya Dasgupta |
| Designation |
Assistant Professor ,Radiation Oncology |
| Affiliation |
Tata Memorial Centre Mumbai |
| Address |
Department of Radiation Oncology, Neuro-oncology Disease Management Group, Room number 1002, Homi Bhabha Building,
Tata Memorial Centre
Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
0224176020 |
| Fax |
|
| Email |
archya1010@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Archya Dasgupta |
| Designation |
Assistant Professor ,Radiation Oncology |
| Affiliation |
Tata Memorial Centre Mumbai |
| Address |
Department of Radiation Oncology, Neuro-oncology Disease Management Group, Room number 1002, Homi Bhabha Building,
Tata Memorial Centre
Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
0224176020 |
| Fax |
|
| Email |
archya1010@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Archya Dasgupta |
| Designation |
Assistant Professor ,Radiation Oncology |
| Affiliation |
Tata Memorial Centre Mumbai |
| Address |
Department of Radiation Oncology, Neuro-oncology Disease Management Group, Room number 1002, Homi Bhabha Building,
Tata Memorial Centre
Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
0224176020 |
| Fax |
|
| Email |
archya1010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, Homi Babha Building, Dr Ernest Borges Rd, Parel East, Mumbai, Maharashtra, India 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre Mumbai |
| Address |
Tata Memorial Centre, Homi Babha Building, Dr Ernest Borges Rd, Parel East, Mumbai, Maharashtra, India 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ARCHYA DASGUPTA |
Tata Memorial Centre |
Department of Radiation Oncology
Neuro-oncology Disease Management Group
Room number 1002
Homi Bhabha Building
Tata Memorial Centre
Mumbai Mumbai MAHARASHTRA |
0224176020
archya1010@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| Tata Memorial Centre Institutional Ethics Committee-II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levetiracetam |
In the experimental arm, Levetiracetam will be tapered by 250- 500 mg every week and stopped. |
| Comparator Agent |
Levetiracetam |
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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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
Imaging within the previous 6 months demonstrating radiologically stable disease status and clinical stability during screening. |
|
| ExclusionCriteria |
| Details |
Include the cumulative incidence of seizures impacting awareness
2-year seizure-free survival in each stratum.
Quality of life assessment
Cost-benefit analysis
Progression-free survival
Overall survival
Post hoc analysis per histological category for seizure control |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
2-year seizure-free
survival for both the arms. Date of seizure relapse after randomization will be considered as an event. |
2 year after accrual of last patient. Considering the expected period of enrolment being 5 years, and another 2 years for follow-up, the primary outcome will be evaluated at 7 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall survival |
7 year |
| Progression-free survival |
7 year |
| Quality of life |
7 year |
|
|
Target Sample Size
|
Total Sample Size="604" Sample Size from India="604"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="7" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients
with brain tumors may experience sudden bursts of uncontrolled electrical
activities in their brain, which is medically termed a seizure. In routine
medical practice, doctors prescribe medications to prevent the consequences of
seizures and avoid the occurrence of seizure events. 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. The study will be
conducted at Tata Memorial Centre with a population of 604 patients for a duration
of seven years. |