SeizuresPhase 3LIBRANCT06442748
Short Versus Long-term Levetiracetam in Brain Tumors
A Phase 3 study testing Levetiracetam in people with Seizures and Brain Tumors, run by Tata Memorial Centre at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seizures, Brain Tumors, Antiepileptics
- What is being tested?
- Levetiracetam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 2 sitesIndia
- Study dates
- 4 Jul 2024to 1 Jun 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites, 2 recruiting
- Recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Archya Dasgupta, 02224177000 ext. 6861, archya1010@gmail.com
Archya Dasgupta
- Not yet recruiting
Manipal Academy of Higher Education
Udupi, Karnataka, 576104
Umesh Velu, +91-8700105161, umesh.vellu@manipal.edu
Umesh Velu
About this study
Official title: Short Versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)
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.
Read the 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.
An interim analysis is planned for harm or futility to stop the trial when quarter of the expected events have occurred (25% information time), if the observed HR is equal to or greater than the non-inferiority margin (1.47).
At the interim analysis, the one-sided P-value is calculated for testing the hypothesis HR = 1 versus the alternative HR > 1.73 (the experimental treatment is doing worse than the standard treatment). If the P-value is <0.0110 at the interim analysis, the trial would stop with the conclusion that non-inferiority cannot be claimed.
The study will be conducted at Tata Memorial Centre and Manipal Academy of Higher Education with a total sample size of 604 patients for a duration of seven years.
- Conditions
- Seizures, Brain Tumors, Antiepileptics, Levetiracetam
- Being tested
- Levetiracetam
- Medical subject headings
- Seizures, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| STANDARD | Other | 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. Receives: Drug: Levetiracetam |
| EXPERIMENTAL | Experimental | In the experimental arm, levetiracetam will be tapered by 250- 500 mg every week and then stopped. Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year seizure free survival
Seizure-free survival measured using Kaplan-Meier product limit method survival calculated from the time of randomization.
Measured: 7 year
Secondary outcomes (6)
Overall survival
Overall survival calculated using Kaplan-Meier product-limit method. Death from any cause will be considered as an event.
Measured: 7 year
Progression-free survival
Progression-free survival calculated using Kaplan-Meier product-limit method. Date of radiological progression will be considered as an event.
Measured: 7 year
Cost-benefit analysis Cost-benefit analysis
Cumulative cost of antiepileptic medications and cost of management of seizures between the two groups will be compared using proportions of expenditure.
Measured: 7 year
Quality of life core questionnaire
The European Organization for Research and Treatment of Cancer (EORTC) quality of life (QOL) core questionnaire (C30) will be used. The summary scores will be calculated from the raw scores as per the manual, ranging from 0 to 100, with higher scores representing better outcomes. The global score and scores of subdomains will be calculated during follow-up and compared with baseline.
Measured: 7 year
Quality of life brain cancer module
The European Organization for Research and Treatment of Cancer (EORTC) brain module (BN20) questionnaire will be used. The summary scores will be calculated from the raw scores as per the manual, ranging from 0 to 100, with higher scores representing better outcomes. The global score and scores of subdomains will be calculated during follow-up and compared with baseline.
Measured: 7 year
Seizure-free survival between two arms using death as a competing risk
Competing risk will be analyzed using Fine and Gray using death as a competing event for seizure.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start4 Jul 2024
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 604 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Manipal Academy for Higher Education
- Responsible party
- Principal investigator, Dr Archya Dasgupta, Tata Memorial Centre
- Investigators
- Archya Dasgupta, Principal investigator, Tata Memorial Centre Mumbai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442748
- Sponsor's protocol ID
- 4385
- Acronym
- LIBRA
- Status last verified
- Feb 2026
- First submitted
- 20 May 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pack AM. Epilepsy Overview and Revised Classification of Seizures and Epilepsies. Continuum (Minneap Minn). 2019 Apr;25(2):306-321. doi: 10.1212/CON.0000000000000707.
PubMed 30921011Olafsson E, Ludvigsson P, Gudmundsson G, Hesdorffer D, Kjartansson O, Hauser WA. Incidence of unprovoked seizures and epilepsy in Iceland and assessment of the epilepsy syndrome classification: a prospective study. Lancet Neurol. 2005 Oct;4(10):627-34. doi: 10.1016/S1474-4422(05)70172-1.
PubMed 16168931Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
PubMed 24730690Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
PubMed 28276062Hildebrand J, Lecaille C, Perennes J, Delattre JY. Epileptic seizures during follow-up of patients treated for primary brain tumors. Neurology. 2005 Jul 26;65(2):212-5. doi: 10.1212/01.wnl.0000168903.09277.8f.
PubMed 16043788Villemure JG, de Tribolet N. Epilepsy in patients with central nervous system tumors. Curr Opin Neurol. 1996 Dec;9(6):424-8. doi: 10.1097/00019052-199612000-00005.
PubMed 9007399Englot DJ, Chang EF, Vecht CJ. Epilepsy and brain tumors. Handb Clin Neurol. 2016;134:267-85. doi: 10.1016/B978-0-12-802997-8.00016-5.
PubMed 26948360Liigant A, Haldre S, Oun A, Linnamagi U, Saar A, Asser T, Kaasik AE. Seizure disorders in patients with brain tumors. Eur Neurol. 2001;45(1):46-51. doi: 10.1159/000052089.
PubMed 11150841Xie M, Wang X, Duan Z, Luan G. Low-grade epilepsy-associated neuroepithelial tumors: Tumor spectrum and diagnosis based on genetic alterations. Front Neurosci. 2023 Jan 9;16:1071314. doi: 10.3389/fnins.2022.1071314. eCollection 2022.
PubMed 36699536Hwang SL, Lin CL, Lee KS, Lieu AS, Kuo TH, Chang CZ, Yen CP, Lin CK, Loh JK, Huang TY, Howng SL. Factors influencing seizures in adult patients with supratentorial astrocytic tumors. Acta Neurochir (Wien). 2004 Jun;146(6):589-94: discussion 594. doi: 10.1007/s00701-004-0266-8. Epub 2004 May 24.
PubMed 15168227Yuen TI, Morokoff AP, Bjorksten A, D'Abaco G, Paradiso L, Finch S, Wong D, Reid CA, Powell KL, Drummond KJ, Rosenthal MA, Kaye AH, O'Brien TJ. Glutamate is associated with a higher risk of seizures in patients with gliomas. Neurology. 2012 Aug 28;79(9):883-9. doi: 10.1212/WNL.0b013e318266fa89. Epub 2012 Jul 25.
PubMed 22843268Andronesi OC, Kim GS, Gerstner E, Batchelor T, Tzika AA, Fantin VR, Vander Heiden MG, Sorensen AG. Detection of 2-hydroxyglutarate in IDH-mutated glioma patients by in vivo spectral-editing and 2D correlation magnetic resonance spectroscopy. Sci Transl Med. 2012 Jan 11;4(116):116ra4. doi: 10.1126/scitranslmed.3002693.
PubMed 22238332Nagashima H, Tanaka K, Sasayama T, Irino Y, Sato N, Takeuchi Y, Kyotani K, Mukasa A, Mizukawa K, Sakata J, Yamamoto Y, Hosoda K, Itoh T, Sasaki R, Kohmura E. Diagnostic value of glutamate with 2-hydroxyglutarate in magnetic resonance spectroscopy for IDH1 mutant glioma. Neuro Oncol. 2016 Nov;18(11):1559-1568. doi: 10.1093/neuonc/now090. Epub 2016 May 5.
PubMed 27154922Englot DJ, Magill ST, Han SJ, Chang EF, Berger MS, McDermott MW. Seizures in supratentorial meningioma: a systematic review and meta-analysis. J Neurosurg. 2016 Jun;124(6):1552-61. doi: 10.3171/2015.4.JNS142742. Epub 2015 Dec 4.
PubMed 26636386Yap KY, Chui WK, Chan A. Drug interactions between chemotherapeutic regimens and antiepileptics. Clin Ther. 2008 Aug;30(8):1385-407. doi: 10.1016/j.clinthera.2008.08.011.
PubMed 18803983
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Versus Long-term Levetiracetam in Brain Tumors: A Phase 3 Randomized Controlled Trial (LIBRA)
- ClinicalTrials.gov ID
- NCT06442748
- Acronym / sponsor ID
- LIBRA / 4385
- Conditions
- Seizures, Brain Tumors, Antiepileptics, Levetiracetam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 604 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Collaborators
- Manipal Academy for Higher Education
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
An interim analysis is planned for harm or futility to stop the trial when quarter of the expected events have occurred (25% information time), if the observed HR is equal to or greater than the non-inferiority margin (1.47).
At the interim analysis, the one-sided P-value is calculated for testing the hypothesis HR = 1 versus the alternative HR > 1.73 (the experimental treatment is doing worse than the standard treatment). If the P-value is <0.0110 at the interim analysis, the trial would stop with the conclusion that non-inferiority cannot be claimed.
The study will be conducted at Tata Memorial Centre and Manipal Academy of Higher Education with a total sample size of 604 patients for a duration of seven years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STANDARD | Other | Drug: LevetiracetamIn 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 | Drug: LevetiracetamIn the experimental arm, levetiracetam will be tapered by 250- 500 mg every week and then stopped. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamLevetiracetam 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. | Drug | EXPERIMENTAL, STANDARD |
Primary outcome
2-year seizure free survival
Time frame: 7 year
Seizure-free survival measured using Kaplan-Meier product limit method survival calculated from the time of randomization.
6 secondary outcomes
Overall survival
Time frame: 7 year
Progression-free survival
Time frame: 7 year
Cost-benefit analysis Cost-benefit analysis
Time frame: 7 year
Quality of life core questionnaire
Time frame: 7 year
Quality of life brain cancer module
Time frame: 7 year
Seizure-free survival between two arms using death as a competing risk
Time frame: 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 30921011Pack AM. Epilepsy Overview and Revised Classification of Seizures and Epilepsies. Continuum (Minneap Minn). 2019 Apr;25(2):306-321. doi: 10.1212/CON.0000000000000707.
- Background: PubMed 16168931Olafsson E, Ludvigsson P, Gudmundsson G, Hesdorffer D, Kjartansson O, Hauser WA. Incidence of unprovoked seizures and epilepsy in Iceland and assessment of the epilepsy syndrome classification: a prospective study. Lancet Neurol. 2005 Oct;4(10):627-34. doi: 10.1016/S1474-4422(05)70172-1.
- Background: PubMed 24730690Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
- Background: PubMed 28276062Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
- Background: PubMed 16043788Hildebrand J, Lecaille C, Perennes J, Delattre JY. Epileptic seizures during follow-up of patients treated for primary brain tumors. Neurology. 2005 Jul 26;65(2):212-5. doi: 10.1212/01.wnl.0000168903.09277.8f.
- Background: PubMed 9007399Villemure JG, de Tribolet N. Epilepsy in patients with central nervous system tumors. Curr Opin Neurol. 1996 Dec;9(6):424-8. doi: 10.1097/00019052-199612000-00005.
- Background: PubMed 26948360Englot DJ, Chang EF, Vecht CJ. Epilepsy and brain tumors. Handb Clin Neurol. 2016;134:267-85. doi: 10.1016/B978-0-12-802997-8.00016-5.
- Background: PubMed 11150841Liigant A, Haldre S, Oun A, Linnamagi U, Saar A, Asser T, Kaasik AE. Seizure disorders in patients with brain tumors. Eur Neurol. 2001;45(1):46-51. doi: 10.1159/000052089.
- Background: PubMed 36699536Xie M, Wang X, Duan Z, Luan G. Low-grade epilepsy-associated neuroepithelial tumors: Tumor spectrum and diagnosis based on genetic alterations. Front Neurosci. 2023 Jan 9;16:1071314. doi: 10.3389/fnins.2022.1071314. eCollection 2022.
- Background: PubMed 15168227Hwang SL, Lin CL, Lee KS, Lieu AS, Kuo TH, Chang CZ, Yen CP, Lin CK, Loh JK, Huang TY, Howng SL. Factors influencing seizures in adult patients with supratentorial astrocytic tumors. Acta Neurochir (Wien). 2004 Jun;146(6):589-94: discussion 594. doi: 10.1007/s00701-004-0266-8. Epub 2004 May 24.
- Background: PubMed 22843268Yuen TI, Morokoff AP, Bjorksten A, D'Abaco G, Paradiso L, Finch S, Wong D, Reid CA, Powell KL, Drummond KJ, Rosenthal MA, Kaye AH, O'Brien TJ. Glutamate is associated with a higher risk of seizures in patients with gliomas. Neurology. 2012 Aug 28;79(9):883-9. doi: 10.1212/WNL.0b013e318266fa89. Epub 2012 Jul 25.
- Background: PubMed 22238332Andronesi OC, Kim GS, Gerstner E, Batchelor T, Tzika AA, Fantin VR, Vander Heiden MG, Sorensen AG. Detection of 2-hydroxyglutarate in IDH-mutated glioma patients by in vivo spectral-editing and 2D correlation magnetic resonance spectroscopy. Sci Transl Med. 2012 Jan 11;4(116):116ra4. doi: 10.1126/scitranslmed.3002693.
Related trials for Seizures
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Archya Dasgupta principal investigator
Tata Memorial Centre Mumbai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam in people with Seizures and Brain Tumors, run by Tata Memorial Centre at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Archya Dasgupta, MD (02224177000 ext. 6861, archya1010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year seizure free survival (time frame: 7 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06442748, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.