| CTRI Number |
CTRI/2025/10/095900 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the effect and Safety of Cenobamate Tablets in Adult Patients suffering from Seizures |
|
Scientific Title of Study
|
A Randomized Multicentre Open Label Active Controlled Parallel Group
Phase III Clinical Study to Evaluate the Efficacy and Safety of Cenobamate
Tablets in Comparison with Eslicarbazepine acetate Tablets in Adult
Patients suffering from Focal Onset Seizures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSN/CT/CENO/11/23 V.2.0 dated 30/JUL/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Chandu Gangadhar Devanpally |
| Designation |
Founder & Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Room no 01 3rd floor office no 302 303 nyati unitree building yerwada
Pune
MAHARASHTRA
411006
India |
| Phone |
07507779256 |
| Fax |
- |
| Email |
cdevanpally@ardent-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Ravindar reddy |
| Designation |
Sr Gr Manager Indian regulatory Affiars |
| Affiliation |
MSN Laboratories Pvt Ltd |
| Address |
MSN House Plot No C 24 industrial estate sanathnagar kondapur road hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9912099129 |
| Fax |
- |
| Email |
krreddy@msnlabs.com |
|
Details of Contact Person
Public Query
|
| Name |
K Ravindar reddy |
| Designation |
Sr Gr Manager Indian regulatory Affiars |
| Affiliation |
MSN Laboratories Pvt Ltd |
| Address |
MSN House Plot No C 24 industrial estate sanathnagar kondapur road hyderabad
Akola
TELANGANA
500018
India |
| Phone |
9912099129 |
| Fax |
- |
| Email |
krreddy@msnlabs.com |
|
|
Source of Monetary or Material Support
|
| M/s MSN Laboratories Private Limited
MSN House Plot No C 24 Industrial Estate Sanath Nagar Hyderabad 500 018
Telangana India |
|
|
Primary Sponsor
|
| Name |
M/s MSN Laboratories Private Limited |
| Address |
MSN House Plot No C 24 Industrial Estate Sanath Nagar Hyderabad 500 018 Telangana India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anand Rajendra Someshwar |
Anand Multispecialty Hospital and Research Center |
4th Floor, Sarthak mall, Mahatma Mandir Road, Sargasan, Gandhinagar 382421
Gandhinagar
GUJARAT |
9824017400
drrajendraanand@yahoo.com |
| Dr Shrikant Deshpande |
Ashirwad Hospital and Research Centre |
Ashirwad Hospital and Research Centr Near Jiajamata Udyan Maratha Section Ulhasnagar 421004
Pune
MAHARASHTRA |
9822017445
-
writetoshrikant@rediffmail.com |
| Dr Abu Zafar Ansari |
City Neurology Centre |
S8/110 A Hamrautia maqbool alam road Varanasi Uttar Pradesh 221002
Varanasi
UTTAR PRADESH |
8543888777
drzafar4@gmail.com |
| Dr Madhukar ShrimantraoDhondji |
Gajanan Hospital and Critical Care Centre |
Sarang Society Plot No.#8 Gajanan Mandir Square Beside L.I.C. Office Opposite Axis Bank Garkheda 431005 Aurangabad
Aurangabad
MAHARASHTRA |
9052896555
mady_18@rediffmail.com |
| Dr Shah Mohd Faisal |
Gangasheel Advanced Medical Research Institute |
C-17 Deen Dayal Puram Bareilly Uttar Pradesh 243122
Bareilly
UTTAR PRADESH |
9592915670
fortiousfaisal007@gmail.com |
| Dr SSV Narasinga Rao |
Government Medical College and Government General Hospital |
Research Wing 2nd Floor Beside FM Ward Government General Hospital Srikakulam 532001
Srikakulam
ANDHRA PRADESH |
9652160975
drnarasingaraossvv@yahoo.com |
| Dr Gunjakar Jaykumar Digambar |
Gunjkar Multispecialty Hospital |
Plot No 315 Spine Road Shivtej Nagar PCMC Pune 411019
Pune
MAHARASHTRA |
9767092120
drjaykumar.gunjkarresearch@gmail.com |
| Dr Janardan |
Indira Gandhi Institute of Medical Sciences |
Room No 225 2nd Floor Ward Block IGIMS Sheikhpura Patna
Patna
BIHAR |
7907129640
nidhi@clintrisearch.com |
| Dr Chalasani Pramod |
Latha Superspeciality Hospital |
D No 29-14-58 2nd Floor Clinical research deportment Prakasam Road Suryaraopet Vijayawada-520002
Krishna
ANDHRA PRADESH |
9848219889
lssh.pramodchalasani@gmail.com |
| Dr Sawale Vishal Madhukar |
Neuro Plus Brain & Spine Advanced Neurology Centre |
Neurology Department ground floor Ahilyadevi Holkar Road Near Tupsakhre Lawns Mumbai Naka Nashik 422002
Nashik
MAHARASHTRA |
9960892928
-
dr.vishalsawale@gmail.com |
| Dr Agrawal Nilesh Radheshyam |
New Era Hospital |
Central Avenue Road Near Telephone exchange Chowk Queta Colony Near Jalaram Mandir Nagpur-440008.
Nagpur
MAHARASHTRA |
8888667808
anileshr@gmail.com |
| Dr Amar Kumar Mishra |
North Bengal Medical College and Hospita |
Department of Neurology North Bengal Medical College And Hospital Susrutanagar Siliguri Darjeeling, West Bengal 734012 India
Darjiling
WEST BENGAL |
9836233996
-
drakm62@gmail.com |
| Dr Pandurang Wattamwar |
Oriion Citicare Superspeciality Hospital |
5-5-70 opposite
Kalash Mangal Karyalay New Osmanpura Chhatrapati
Sambhajinagar Aurangabad 431005
Aurangabad
MAHARASHTRA |
7387013361
drpandurang.oriion@gmail.com |
| Dr Vikas Shukla |
Panacea Multi Super Speciality Hospital |
Neurology department ground floor 117/473 Kakadeo Kanpur Between Neercheer Chauraha Dabal Pulia
Kanpur Dehat
UTTAR PRADESH |
9935523711
-
drvikasshukla1971@gmail.com |
| Dr Varun Kodam |
TX Hospitals |
Block 1 8-2-679 Block 2:8-2-680/A Road No 12 Banjara hills Hyderabad
Hyderabad
TELANGANA |
6302297817
clinicalresearch1@txhospitals.in |
| Dr Bala Pradeep Boyidapu |
Visakha Institute of Medical Sciences |
Department of Neurology Ground Floor OPD Building Visakha Institute of Medical Sciences Hanuman thavaka Visakhapatnam-530040
Visakhapatnam
ANDHRA PRADESH |
70212 87683
drbbalapradeepresearch@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee TX Hospitals |
Approved |
| Institutional Ethics Committee Sangvi Multispecility Hospital |
Approved |
| Anand Ethics Committee |
Approved |
| Ashirwad Ethics Committee |
Approved |
| Ikon Ethics Committee For Research On Human Subjec |
Approved |
| Institutional Ethics Committee Gangasheel Advanced Medical Research Institute |
Approved |
| Institutional Ethics Committee Lifetron |
Approved |
| Institutional Ethics Committee North Bengal Medical College & Hospital |
Approved |
| Institutional Ethics Committee, Government General Hospital |
Approved |
| Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, Visakha Institute of Medical Sciences |
Approved |
| Latha Super specialities Hospital Ethics Committee |
Approved |
| Muktai Hospital Institutional Ethics Committee |
Approved |
| New Era Ethics Committee |
Approved |
| Oriion Citicare Hospital-Institutional Ethics Committee |
Approved |
| Shubham Sudbhawana Superspeciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G401||Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cenobamate Tablets 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200
mg |
Subjects will be advised to consume Test product
once daily orally after dinner for 18 weeks of treatment duration. The dose
of the drugs will get up-titrated over a period 10 weeks and all Subjects
will start to receive the maintenance dose from Week 11 onwards till
Week 16. The maintenance phase will be Week 11 Week 16. Then during
week 17 and week 18 Cenobamate will get tapered off |
| Comparator Agent |
Eslicarbazepine 400 mg, 600 mg and 800 mg |
Subjects will be advised to consume Comparator drug
once daily orally after dinner for 18 weeks of treatment duration. The dose
of the drugs will get up-titrated over a period 10 weeks and all Subjects
will start to receive the maintenance dose from Week 11 onwards till
Week 16. The maintenance phase will be Week 11 Week 16. Then during
week 17 and week 18 Cenobamate will get tapered off. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Male or female subjects aged 18 to 65 years at the
time of screening
2 Subjects with confirmed diagnosis of focal onset seizures with or without secondary generalization for at least 12 months as defined in
the International League Against Epilepsy classification of seizures focal onset seizures may be focal aware motor or focal
impaired awareness or focal with secondary tonic clonic generalization
3 Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4 weeks prior to Visit 1
4 Have a minimum of 4 partial onset seizures during the 4 week run in period A caregiver or witness must be with the subject for a sufficient
duration to accurately chronicle the occurrence of seizures These seizures must have been documented
in the subjects diary
5 Subjects with ability to understand and provide voluntary written informed consent to participate in this clinical investigation and from whom IECIRB approved written informed consent has been obtained
6 Subjects who can understand and comply with the requirements of the study protocol like consuming the medications as instructed returning for the required treatment period visits complying with
prohibited medications and be able to complete the study
7 Female Subjects of childbearing potential practicing an acceptable method of birth control such as sexual abstinence intrauterine device
or a double barrier method or vaginal spermicidal suppository for the duration of the study and up to 28 days after the last dose of study drug
as judged by the investigator study physician and agree to follow the same
OR
Postmenopausal for at least 1 year
OR
Surgically sterile bilateral tubal ligation bilateral oophorectomy
hysterectomy has been performed on the Subject |
|
| ExclusionCriteria |
| Details |
1 Subjects with Focal seizure without a motor component
2 Subjects with Primary generalised onset or unknown onset
seizures
3 Subjects with seizures occurring in clusters
4 Subjects with Lennox Gastaut syndrome absence seizures or
with seizures due to an underlying medical illness or metabolic
syndrome
5 Subjects with history of Status Epilepticus within 3 months of
enrolment
6 Subjects with history of non-epileptic seizures
7 Subjects with progressive neurological disorders including but
8 Subjects with an active CNS infection demyelinating disease
neurodegenerative disease or any CNS disease deemed to be
progressive during the course of the study that may confound
the interpretation of study results
9 Subjects with known allergic reaction or intolerance to
Cenobamate Eslicarbazepine Carbamazepine
Oxcarbazepine and or any excipients of the study drug
10 History of drug abuse and or alcohol abuse within last 2 years
11 Family history of familial short QT syndrome
12 Subjects with serious psychiatric disorders like Schizophrenia
Depression or Bipolar disorder
13 A yes answer to Question 1 or 2 of the CSSRS Suicidal
Ideation section for the past 6 months or a yes answer to
any of the CSSRS Suicidal Behaviour section question for
the past 2 years
14 Subjects operating hazardous machineries including
automobiles
15 History of cardiac conditions including myocardial Infarction
unstable angina transient ischemic attacks, arrhythmia
cerebrovascular accident cardiac surgery or revascularization
within 3 months of screening
16 Subjects who had previously failed an adequate trial of
Cenobamate
17 History of severe untreated asthma anaphylactic reactions or
severe urticaria and or angioedema
18 Any abnormality on 12 lead ECG at screening that in the
opinion of the investigator is clinically significant and is judged
as potential risk for subjects participation in the study
19 Subjects with a history of anaemia or haemoglobinopathy
And or haemoglobin less than10 g per dL at screening or any bleeding
disorder
20 Subjects having uncontrolled HTN with SBP greater than 160 mmHg
And or DBP greater than 100 mmHg with or without antihypertensives
at screening
21 Subjects with clinically significant renal disorders
a eGFR less than 90 mL per min
b Serum creatinine levels greater than or equal to1point 5mg per dL
22 Subjects with hypothyroidism or hyperthyroidism
23 Subjects with HbA1C greater than 9 percentage
24 Subjects with known history of HIV Hepatitis B or Hepatitis C
25 Subjects with hepatocellular insufficiency and in Subjects with
hepatic failure or active liver disease abnormal Liver Function
Test with Total bilirubin more than 1point 5 times the upper limit of
normal or ALT AST more than 2 point 5 times the UNL
26 Subjects with signs & symptoms of Covid19 infection
27 Subjects with active or prior severe unstable or uncontrolled
respiratory hepatic renal disease immunological or
neurological disorders other than focal epilepsy
28 Subjects with any other clinically significant medical condition
or laboratory values at screening that might adversely impact
the safety of the study participants or confound the study
results
29 Subjects who have participated in another investigational
study within 90 days prior to screening in this study or
planning to participate during the study
30 Active malignancy or history of malignancy
31 Currently taking prohibited concomitant medication which
interrupt study medication outcome.
32 Subjects with participation in a blood or plasma donation
program within 30 days prior to the study intervention
administration
33 Suspected inability or unwillingness to comply with the study
procedures
34 Subjects otherwise judged to be inappropriate for inclusion in
The study by the investigator judgement
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in seizure frequency per 28 days |
per 28 days from baseline to week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Percentage of responders at the end of 16 weeks
2 Proportion of Subjects who have at least 75% reduction in seizure
frequency per 28 days during the maintenance phase, as measured from baseline |
1 Baseline to week 16
2 Baseline to week 16 |
|
|
Target Sample Size
|
Total Sample Size="254"
Sample Size from India="254"
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)
|
22/10/2025 |
| 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
Modification(s)
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This is a Randomized, Multicentre, Open Label, Active Controlled, Parallel Group, Phase III Clinical Study to Evaluate the Efficacy and Safety of Cenobamate Tablets in Comparison with Eslicarbazepine acetate Tablets in Adult Patients suffering from Focal Onset Seizures. Subjects randomized to the test arm will receive Cenobamate tablets once daily for 18 weeks. Subjects will receive Cenobamate 12.5 mg tablets once daily for the first 2 weeks. The dose will be up titrated to 25 mg once daily on week 3, 50 mg once daily on week 5, 100 mg once daily on week 7 and 150 mg once daily on week 9. From week 11 to 16 (Day 77 to 112) Subjects will receive 200 mg Cenobamate tablets once daily (maintenance dose). Following this period, the dose will be tapered off. On week 17 the dose will get down-titrated to 100 mg once daily and after 4 days the dose will get reduced to 50 mg once daily. On week 18 the dose will get down-titrated to 25 mg once daily and after 4 days the dose will get reduced to 12.5 mg once daily and then stopped. Subjects randomized to the comparator arm will receive Eslicarbazepine 400 mg tablets once daily for the first 5 weeks. From Week 6 to Week 10 Subjects will receive Eslicarbazepine 600 mg tablets once daily. From Week 11 to 18 (Day 77 to 126) Subjects will receive the maintenance dose of 800 mg Eslicarbazepine tablets once daily.The total study duration is approximately 23 weeks (1 week screening period, 4 weeks run-in period, 16 weeks treatment period and 2 weeks tapering period |