FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/12/010906 [Registered on: 18/12/2017] Trial Registered Retrospectively
Last Modified On: 13/11/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational Product Registry Study 
Study Design  Other 
Public Title of Study   A study to describe clinical effect of Clobazam in patients with epilepsy 
Scientific Title of Study   An observational study to describe the clinical impact (seizure freedom for 12 months) of clobazm (Frisium®) as an adjunct therapy in patients who are not adequately stabilized with their anticonvulsant monotherapy 
Trial Acronym  ADD ON 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  ClinicalTrials.gov 
Nil, Version 1.1, Dated 15-Dec-2016   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr P Satishchandra 
Designation  Former Director/Vice Chancellor & Senior Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neurosciences, Neuro Faculty Building, NIMHANS Campus, Hosur Main Road, Bengaluru, Karnataka - 560029

Bangalore
KARNATAKA
560029
India 
Phone  091-80-26995001  
Fax  091-80-26564830  
Email  drpsatishchandra@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Chodankar 
Designation  Sr. Medical Advisor 
Affiliation  Sanofi India Limited 
Address  Sanofi India Limited Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai – 400072

Mumbai
MAHARASHTRA
400072
India 
Phone  9096867313  
Fax  02228032840  
Email  Deepa.Chodankar@sanofi.com  
 
Details of Contact Person
Public Query  
Name  Raviteja Adapa 
Designation  Associate Clinical Project Leader 
Affiliation  Sanofi India Limited 
Address  Sanofi India Limited Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai – 400072

Mumbai
MAHARASHTRA
400 072
India 
Phone  02228032665  
Fax  02228032840  
Email  Raviteja.Adapa@sanofi.com  
 
Source of Monetary or Material Support  
Sanofi India Limited Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai – 400072  
 
Primary Sponsor  
Name  Sanofi India Limited 
Address  Sanofi House, CTS No. 117-B, L&T Business Park, Saki Vihar Road, Powai, Mumbai – 400072  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 32  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek  Aarogyam Neuro Clinic  47 A(B), Sahdeo Mahto Marg, West of Children Park, Sri Krishna Puri, Patana Bihar 800001
Patna
BIHAR 		 9572535945

drabhi7@gmail.com 
Dr Majid abdul Gaffar  Apex Super Speciality Hospital  5-8 Bassayye nagar, Opposite SFS School, Jalna Road, Aurangabad, 431001
Aurangabad
MAHARASHTRA 		 9822458502

Majiddoc4@yahoo.com 
Dr Anirudha Mukund Apte  Apte Neuro Clinic  Apte Neuro Clinic HG – 1B, International trade centre, First Floor, Beside Radha Krinshna Hotel, Majura gate, Ring Road, Surat – 395002
Surat
GUJARAT 		 9825123878

amapte@yahoo.com 
Dr Bindu Menon  Axon Neuro and Rehab Care  D.No 16-7-129,2nd Street, Ramamurthy Nagar, Near Kalyan Jewellers, Nellore District, Andhra Pradesh-524001
Nellore
ANDHRA PRADESH 		 9866223905

bindu.epilepsycare@gmail.com 
Dr K Venkateshwarlu  Doctor’s Plaza  Opposite K.G.H, Vishakapatanam – 530002
Visakhapatnam
ANDHRA PRADESH 		 9848190710

kvluneuro@hotmail.com 
Dr Lakshmanan Sankarnarayan  Doctor’s Plaza  No.5, V.O.C Street, West Tambaram, Chennai 600 045
Chennai
TAMIL NADU 		 9790964520

drlsnmddm@yahoo.co.in 
DrJ B Agadi  Dr. Agadi’s Clinic  No.63, 10th A Cross, 2nd Main, 2nd stage, west of Chord Road, Bangalore 560086
Bangalore
KARNATAKA 		 9448076575

drjbagadi@gmail.com 
Dr Vinay Kumar Agarwal   Dr.  Vinay Kumar Agarwal  C/o Pragati Maternity Home & Infertility Centre, P - 5/4, Stadium Road DD puram, Delha Peer, Bareilly – 243122
Bareilly
UTTAR PRADESH 		 9897364765

vinay_agarwalneu@rediffmail.com 
Dr Dushyant Chauhan   Dr. Dushyant Chauhan’s Private Clinic  201, 202, Rajratna Arcade, Block A, Near Maninagar Station, Ahmedabad 380 008
Ahmadabad
GUJARAT 		 9825065637

drdushyant@hotmail.com 
Dr P C Gilvaz  Dr. Gilvaz Clinic  IX/ 333A, Cosmo Gardens, Koorkenchery, ‎Thrissur, Kerala 680007
Thrissur
KERALA 		 9847046794

gilvaz@gmail.com 
Dr VT Ravi  Dr. Ravi’s Neuro Centre  Jubilee Road, Near Bharath Gas, Perinathalmnna, Kerala, 679 332
Malappuram
KERALA 		 9037225570

drvtravi@yahoo.com 
Dr Sushil Razdan  Dr. Razdan’s clinic  at 7, Bhagwati Nagar, Canal Road Jammu 180 007
Jammu
JAMMU & KASHMIR 		 9419196696

razdansushil@yahoo.co.in 
Dr Siddhartha Garg   Dr. Siddhartha Garg Neuro Clinic  74-Rose enclave, Near Rose Garden, Ludhiana 141 001
Ludhiana
PUNJAB 		 9878611162

Siddhartha_dm@yahoo.com 
Dr K P Swain  Dr. Swain’s Private Clinic  Dr. Swain’s Private Clinic, c/o Sabitri Medical and General Store, Near SBI, College Square, Cuttack, Odisha,753003
Cuttack
ORISSA 		 9437176278

kali.swain@gmail.com 
Dr Dinesh Nayak  Fortis Malar Hospital  Room No.123, Department of Neurology, Clinical Research 7th Floor, A block, No.52, 1st Main Road, Gandhi Nagar, Adyar, Chennai, Tamil Nadu 600020
Chennai
TAMIL NADU 		 9840642724

dr.dineshnayak@gmail.com 
Dr Monica Malokar  Malokar Hospital  Akola, Maharashtra - 444001
Akola
MAHARASHTRA 		 9823360079

mkanphade@yahoo.com 
Dr PAHARI GHOSH   Medicare Clinic  57 RASH BEHAM AVENUE, KOLKATA- 700026
Kolkata
WEST BENGAL 		 9831023296

ghosh.pahari@gmail.com 
Dr Vinod Arora   Meerut Neurology centre  Hapur Road, EVES Crossing, Meerut , Uttar Pradesh 250001
Meerut
UTTAR PRADESH 		 9837031331

drvinodarora10@yahoo.co.in 
Dr Sanjeev V K  Muthoot healthcare private Limited  Muthoot health care Private Limited, College Road, Kozchecherry, Kerala 689 641
Pathanamthitta
KERALA 		 9447562090

sanjeevvk@hotmail.com 
Dr Tapas Kumar Banerjee  National Neurosciences Centre  Peerless Hospital Campus, 360, Panchasayar, Kolkata 700 094
Kolkata
WEST BENGAL 		 9830061293

tapaskumarb@gmail.com 
Dr Chaturbhuj Rathore  Neuro-Cure Clinic  Saakar Splendora II, Nr. Merryland Party Plot, Behind Macdonalds, Sama Savli, Vemali, Vadodara - 390008
Vadodara
GUJARAT 		 9909342232

cbrathore@rediffmail.com 
Dr Sudhir Vadilal Shah   Neurology Centre  206, Sangini Complex, Doctor House, Ellisbridge, Ahmedabad – 380006
Ahmadabad
GUJARAT 		 9825009521

sudhirshah@hotmail.com 
Dr S K Jha  Neurology Clinic  D-61, Rajesh kumar Path, Sri Krishnapuri, near Basawan Park, Patna- 800 001
Patna
BIHAR 		 9430955320

sudhirkjha@hotmail.com 
Dr K Ramadoss   Precision Neuro Clinic  39, East Ponnurangam Road, R.S. Puram, Coimbtore - 641002
Coimbatore
TAMIL NADU 		 9894995380

ramneuro@yahoo.com 
Dr Amitav Rath   Rabindra Healthcare Pvt Ltd  Near Keshari Talkies, 4, Kharavel Nagar Unit – III BBSR, Odisha 751 001
Khordha
ORISSA 		 9178061805

amitav.dr@gmail.com 
Dr Nagarjunakonda Venkata Sundaracharya   Sai Venkata Neuro Care Centre  8th Lane, Gunturuvari Thota, Guntur- 522001, Andhra Pradesh
Guntur
ANDHRA PRADESH 		 9440257675

sundarachary@yahoo.com 
Dr Rajesh Gupta  Shri Balaji Gynac and Neuro Clinic  5 Sharad Vihar, Near Kakarduma Metro Station, Delhi 110092
East
DELHI 		 9810541473

drrajeshgupta@hotmail.com 
Dr Lakshmi Narasimhan  SR Neuro Cliniqu  No.109, R.K. Mutt Road, Mandaveli, Chennai, Tamil Nadu 600028
Chennai
TAMIL NADU 		 9444380409

LakshhmiN@gmail.com 
Dr K Asokan   Sri Ramkrishna Hospital  395, Sarojini Naidu Road, Sidhapudur, Coimbtore- 641044
Coimbatore
TAMIL NADU 		 9843019979

asokan54@rediffmail.com 
Dr Amlan Mandal  The Brain  20152 Chakgaria, UPTC0246, 2nd Floor, Kolkata 700 094
Kolkata
WEST BENGAL 		 9831599727

mandal_amlan@yahoo.co.in 
Dr N Thilothammal  Thilothammal Clinic  4th main road, R A PURAM Chennai Tamil Nadu 600028
Chennai
TAMIL NADU 		 9444985005

Dr.n.thilothammmal@gmail.com 
Dr Nandan yardi  Yardi Epilepsy Clinic  Vidya Sah, Bank Bldg, Near Karve Statue, 754/B,, Maharshi Karve Rd, Kothrud, Pune, Maharashtra 411038
Pune
MAHARASHTRA 		 9850066005

nandan.yardi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 32  
Name of Committee  Approval Status 
Dr. Abhishek-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Amitav Rath-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Amlan Mandal-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Anirudha Mukund Apte-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Dinesh Nayak-Intitutional Ethics Committee Fortis Malar Hospital  Submittted/Under Review 
Dr. Dushyant Chauhan-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. K. Asokan-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. K. P. Swain-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. K. Ramadoss-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. K. Ventateshwarlu-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Lakshmanan Sankarnarayan-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Majid abdul Gaffar-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Monica Malokar-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. N. Thilothamal-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Nagarajunakonda Venkata Sundaracharya-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Nandan yardi-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. P. C Gilvaz-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Pahari Ghosh- Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Rajesh Gupta-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. S. K. Jha-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Sanjeev V K-Intitutional Ethics Committee Muthoot health care private limited  Approved 
Dr. Siddhartha Garg-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Sushil Razdan-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Tapas Kumar Banerjee-National Neurosciences Centre, Calcutta  Approved 
Dr. V.T. Ravi-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Vinay Kumar Agarwal-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr. Vinod Arora-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr.Bindu Menon-Ethics Committee Jahangir Clinical development Centre  Approved 
Dr.J. B Agadi-Ethics Committee Jahangir Clinical development Centre  Approved 
Ethics Committee Jahangir Clinical development Centre-Dr. Chaturbhuj Rathore  Approved 
Ethics Committee Jahangir Clinical development Centre-Dr. Lakshmi Narasimhan  Approved 
Ethics Committee Jahangir Clinical development Centre-Dr. Sudhir Vadilal Shah   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Epilepsy, (1) ICD-10 Condition: G409||Epilepsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patient more than equal to 3 years of age
2. Investigator decides to prescribing Frisium as an adjunctive therapy in patients with epilepsy who are not adequately stabilized
3. Signed Informed Consent obtained from the patients or legally acceptable representative prior to any study related procedure
Note-Frisium would be prescribed by the Investigator based on his/her clinical judgement.This study will not influence the Investigators decision to either prescribe or not to prescribe Frisium.If the patient is prescribed Frisium and if he/she satisfies all the inclusion and exclusion criteria, he/she may be recruited in this study. 
 
ExclusionCriteria 
Details  1. Patient with a known hypersensitivity to clobazam or any of the excipients of Frisium 2. Patient with any history of drug or alcohol dependence 3. Patient with known case of myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome or severe impairment of liver/ renal function 4. Patient with recognized epilepsy syndrome 5. Patient and/or caretaker will not be able to complete the patients diary
6. Patient participating in any clinical trial or was part of a clinical trial in the last 3 months 7. Patient who is pregnant or breastfeeding 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To describe the clinical impact (seizure freedom for 12 months) of Clobazam (Frisium®) as an adjunct therapy in patients who are not adequately stabilized with their anticonvulsant monotherapy.  Time point would be 12 months for both primary and secondary outcome 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate safety of Frisium®
2. To evaluate the reasons for adding Frisium®
3. To describe the management of epilepsy (in addition to Frisium®) selected by the investigator for patients who are not adequately stabilized with their anticonvulsant monotherapy.
4. To evaluate the profile of the patient who are prescribed Frisium®
5. To evaluate compliance of these patients to Frisium®
6. To explore the reasons for discontinuation of Frisium® 		 12 months 
 
Target Sample Size   Total Sample Size="770"
Sample Size from India="770" 
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   N/A 
Date of First Enrollment (India)   03/06/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
1) This study is designed  to assess the clinical impact of Frisium as an adjunct therapy for a period of 12 months in patients with seizures who are not adequately controlled with anticonvulsant monotherapy in the real world clinical practice in India.
2) It will also help  to assess the effect of Frisium as an adjuvant therapy to improve the quality of life of subject and keeping them seizure free for a period of 12 months in subjects who are not adequately stabilized with their anticonvulsant monotherapy
3) In addition to this we will get the general safety of Frisium in terms of occurrence of overall adverse events.
 
Close