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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.  

 
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