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1 Clinical Trial Details (PDF Generation Date :- Wed, 16 Jan :26:55 GMT) CTRI Number CTRI/2010/091/ [Registered on: 13/09/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Randized, Parallel Group, Active Controlled Trial A Clinical Trial to Investigate Efficacy and Safety of Eslicarbazepine Acetate Tablet versus Oxcarbazepine SR Tablet Eslicarbazepine as an Adjunctive Treatment in Patients With Refractory Epilepsy Suffering Fr Partial Onset Seizures With or Without Secondary Generalisation A Multicenter, Randized Open-Label, Cparative, Prospective Clinical Trial to Investigate Efficacy and Safety of Eslicarbazepine Acetate Tablet versus Oxcarbazepine SR Tablet as an Adjunctive Treatment in Patients With Refractory Epilepsy Suffering Fr Partial Onset Seizures With or Without Secondary Generalisation Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) CT/ESLI/EPI/09-01 Protocol Number Details of Principal Investigator Dr. Ambrish Srivastava ambrishsrivastava@torrentpharma.c Details Contact Person (Scientific Query) Dr. Ambrish Srivastava General Manager ambrishsrivastava@torrentpharma.c Details Contact Person (Public Query) Ms. Sweety Shah page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study > Nil Source of Monetary or Material Support > Torrent Pharmaceuticals Limited, Torrent Research Centre, Village Bhat, Dist. -. Gujarat,. Type of Sponsor Nil List of Countries of Principal Investigator Dr. Rajendra Dugani Dr. M A Majid Primary Sponsor Details Torrent Pharmaceuticals Limited of Site Site Phone/Fax/ #457/1B, Vivekanand Road, Deshpande Nagar Road, Hubli Apex Super speciality, Dr. Sushil Razdan Bhagwati Nagar Clinic Asca- Sidhra,, 7-Bhagwati Nagar Canal Road- Jammu JAMMU & KASHMIR Dr. Kamlesh Das Dr.B. S. Keshava Burdwan Medical Collage, Burdwan Medical Collage &, Road, Pin , West Bengal City Neuro Centre, 483/4, Kanti Cplex, Agrahara, Near JSS, Mysore dr_ri_dugani@yahoo.co.in 6 & 7, Bassaye Nagar ,Opp.Yashoda - Aurangabad majiddoc4@yahoo.c BIHAR, , Mysore KARNATAKA Dr. Ravindra Lodha Dr Ravindra Lodha 4 Nal Kunj Soceity, Civil Camp Road,Shahibaugh, Ahmedabad- Ahmadabad Dr. S. K. Gupta GMC Jammu Bakshi Nagar,Jammu- Dr. Tarun Nagpal Jabalpur & Research Centre Russell Crossing,Jabal pur Jabalpur razdansushil@yahoo.co.in drkamleshdas@rediffm ail.c keshavabelur@gmail.co m ravindralodha@indiatim es.c guptaskneuro@yahoo.c tarunnagpal@hotmail.c page 2 / 5

3 Details of Ethics Cmittee Dr. Vikram Sinha Jadhav Dr. Mrs P. Vijaya Dr. Rahul Kulkarni Jadhav & Neurology Centre Lalitha Super Speciality Mastishka Neurology Clinic MADHYA PRADESH Vantmore Corner,Miraj Kothapet,Guntur Guntur ANDHRA PRADESH 4th floor, Akshya Centre, 1050, Shukrawar peth, Opposite Pandit Auto, Near Hira Baug, Tilak Road Pune MAHARASHTRA Dr. Anup Bhattacharya Neuro Care B1/8 Kalyani,Dist. Nadiya Dr. K. Ramadoss Dr. Anupam Sahni Dr. P G Reddy Dr. Ramesh Madhav Patankar Dr. Ganesh N. Kini Precision Neurolab, 17-A Cowly brown Road, RS Puram, Coimbatore, Tamilnadu Sahni Neurocare Centre Sai Krishna Neuro Shree,- Coimbatore TAMIL NADU, Shop No:8, J.D.A. Cplex, Opp. Milan Sweet,,Madan Mahal Chowk- Jabalpur MADHYA PRADESH 3-4-1; Kachegudav,Hyd erabad Hyderabad ANDHRA PRADESH Near Geeta Bhavan Hotel, Ambedkar Garden,Chembur- 71- Mumbai MAHARASHTRA Vimala Neurology,- Centre & EEG Clinic, Mumbai G-3 Urmila Cplex, MAHARASHTRA Opp. Hotel Malhar, 19th Roa, Chembur, Mumbai rushiljadhav@rediffmail. c vijayapvr@yahoo.c rahulneuro@gmail.c anupbhattachary@yaho o.co.in ramneuro@yahoo.c anupamsahni@yahoo.c dr_govardhan18@yaho o.c patrameshneuro@yaho o.co.in drganeshkini@yahoo.c o.in of Cmittee Approval Status Date of Approval Is Independent Ethics Cmittee? page 3 / 5

4 Regulatory Clearance Status fr DCGI Health Condition / Problems Studied Intervention / Cparator Agent Inclusion Criteria Exclusion Criteria Lalitha Super Speciality Ethics Cmittee SKS Ethics Cmittee Status Approved/Obtained Health Type Approved No Date Specified Not Available Approved No Date Specified Not Available Date No Date Specified Condition Type Details Refractory Epilepsy Suffering Fr Partial Onset Seizures With or Without Secondary Generalisation Intervention Eslicarbazepine Acetate 400mg for one week, then after 800mg for next three weeks, then after based on response up to 1200mg upon investigator's judgment up to 12 weeks. Cparator Agent Age Fr Age To Gender Details Details Oxcarbazepine Extended Release Inclusion Criteria 600mg for one week, then after 900mg for next three weeks, then after based on response up to 1200mg upon investigator's judgment up to 12 weeks. Male and female patients between 18 and 65 years of age (both inclusive) with Refractory Epilepsy Suffering Fr Partial Onset Seizures With or Without Secondary Generalisation and maintaining a stable dose regimen of at least one Anti-epileptic drug (AED) or maximum 3 AED for one month up to screening Patients with documented history of at least 1 seizure in last one month. Patients willing to give written informed consent. Exclusion Criteria Patients with seizures occurring in clusters Patients with Status Epilepticus within 3 months of enrolment Patients with history of non-epileptic seizures Patient with simple partial seizure without a motor cponent Patient with Primary generalised epilepsy. Patients with known allergic reaction or intolerance to study drugs and/or excipients or Carbamezepine or Oxcarbazepine Patients with liver enzymes (ALT and AST) more than 2.5X the normal value and/or bilirubin more than 1.5X the normal value Relevant clinical laboratory abnormalities (e.g. Na+ <130 mmol/l, WBC count <3,000 cells/mm3) Creatinine clearance (CLCR) 60 ml/min. History of drug abuse and alcohol abuse with last 2 years. Patients taking felbamate, vigabatrin, topiramate, psychotropic drugs, anticholinergic page 4 / 5

5 Powered by TCPDF ( PDF of Trial Method of Generating Rand Sequence Method of Concealment Blinding/Masking Cputer generated randization Open Label drugs, anti-parkinson medication, α1-antagonist and α2-antagonist. Patient taking Oxcarbazepine tablets as monotherapy or add on therapy. Intake of sodium lowering medications eg. Diuretics Patients with progressive neurological disorders like multiple sclerosis, Guillain-Barre syndre Presence of significant cardiac dysfunction or clinically important ECG abnormalities Patients with serious psychiatric disorders like Schizophrenia, Bipolar disorder with suicidal tendencies Use of neuroleptics, MOA inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening Patients who have participated in any other drug trial within the four weeks preceding study entry Wen patient of childbearing potential, not practicing medically acceptable (non-hormonal) method of contraception Pregnant or lactating wen, children and adolescents below 18 years Primary Outce Outce Timepoints Median percentage reduction in frequency of seizures cpared to baseline Seizure frequency every four weekly. Cparision between end of trail and base line seizure frequency Secondary Outce Outce Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Responder Rate (defined as proportion of patients with a minimum of 50% reduction in seizure frequency fr baseline) Number of seizure-free patients during the treatment period Change in QOLIE-31 score Physician?s and patient?s global assessment to the treatment Total Sample Size=210 Sample Size fr = No Date Specified 19/03/2010 Years=0 Months=6 Days=0 Cpleted Based on seizure frency reduction page 5 / 5