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CTRI Number  CTRI/2010/091/000100 [Registered on: 13/09/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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 From Partial Onset Seizures With or Without Secondary Generalisation 
Scientific Title of Study   A Multicenter, Randomized Open-Label, Comparative, 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 From Partial Onset Seizures With or Without Secondary Generalisation 
Secondary IDs if Any  
Secondary ID  Identifier 
CT/ESLI/EPI/09-01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Ambrish Srivastava 
Designation   
Affiliation   
Address  Torrent Research Centre, Village Bhat
Gandhinagar
Gandhinagar
GUJARAT
382428
India 
Phone  07923969100  
Fax  07923969135  
Email  ambrishsrivastava@torrentpharma.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Ambrish Srivastava 
Designation   
Affiliation  General Manager 
Address  Torrent Research Centre, Village Bhat
Gandhinagar
Gandhinagar
GUJARAT
382428
India 
Phone  07923969100  
Fax  07923969135  
Email  ambrishsrivastava@torrentpharma.com  
 
Details of Contact Person
Public Query
 
Name  Ms. Sweety Shah 
Designation   
Affiliation   
Address  Torrent Research Centre, Village Bhat
Gandhinagar
Gandhinagar
GUJARAT
382428
India 
Phone  07923969100  
Fax  07923969135  
Email  sweetyshah@torrentpharma.com  
 
Source of Monetary or Material Support  
Nil 
Torrent Pharmaceuticals Limited, Torrent Research Centre, Village Bhat, Dist. Gandhinagar-382428. Gujarat, India. 
 
Primary Sponsor  
Name  Torrent Pharmaceuticals Limited 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Rajendra Dugani  #457/1B, Vivekanand Hospital Road, Deshpande Nagar Road, Hubli-580029  ,-580029

 
9448114008

dr_ri_dugani@yahoo.co.in 
Dr. M A Majid  Apex Super speciality Hospital   6 & 7, Bassaye Nagar ,Opp.Yashoda Hospital-
Aurangabad
BIHAR 
09822458502

majiddoc4@yahoo.com 
Dr. Sushil Razdan  Bhagwati Nagar Clinic   Ascoma- Sidhra,, 7-Bhagwati Nagar Canal Road-
Jammu
JAMMU & KASHMIR 
09419196696

razdansushil@yahoo.co.in 
Dr. Kamlesh Das  Burdwan Medical Collage, Burdwan Medical Collage & Hospital, Hospital Road, Pin-713101, West Bengal  ,-713101

 
9434703497

drkamleshdas@rediffmail.com 
Dr.B. S. Keshava  City Neuro Centre, 483/4, Kanti Complex, Agrahara, Near JSS Hospital, Mysore- 570004  ,-570004
Mysore
KARNATAKA 
984551813

keshavabelur@gmail.com 
Dr. Ravindra Lodha  Dr Ravindra Lodha  4 Nal Kunj Soceity, Civil Camp Road ,Shahibaugh, Ahmedabad-
Ahmadabad
GUJARAT 
09825063117

ravindralodha@indiatimes.com 
Dr. S. K. Gupta  GMC Jammu  Bakshi Nagar,Jammu-

 
09419184600

guptaskneuro@yahoo.com 
Dr. Tarun Nagpal  Jabalpur Hospital & Research Centre   Russell Crossing,Jabalpur-482002
Jabalpur
MADHYA PRADESH 
09827047665

tarunnagpal@hotmail.com 
Dr. Vikram Sinha Jadhav  Jadhav Hospital & Neurology Centre  Vantmore Corner,Miraj-416410

 
09890452709

rushiljadhav@rediffmail.com 
Dr. Mrs P. Vijaya  Lalitha Super Speciality Hospital  Kothapet ,Guntur-522001
Guntur
ANDHRA PRADESH 
09440808621

vijayapvr@yahoo.com 
Dr. Rahul Kulkarni  Mastishka Neurology Clinic   4th floor, Akshya Centre, 1050, Shukrawar peth, Opposite Pandit Auto, Near Hira Baug, Tilak Road-411002
Pune
MAHARASHTRA 
09822012588

rahulneuro@gmail.com  
Dr. Anup Bhattacharya  Neuro Care  B1/8 Kalyani,Dist. Nadiya-741235

 
09831146413

anupbhattachary@yahoo.co.in 
Dr. K. Ramadoss  Precision Neurolab, 17-A Cowly brown Road, RS Puram, Coimbatore, Tamilnadu  ,-
Coimbatore
TAMIL NADU 
9894995380

ramneuro@yahoo.com 
Dr. Anupam Sahni  Sahni Neurocare Centre  , Shop No:8, J.D.A. Complex, Opp. Milan Sweet, ,Madan Mahal Chowk-
Jabalpur
MADHYA PRADESH 
09329702244

anupamsahni@yahoo.com 
Dr. P G Reddy  Sai Krishna Neuro Hospital  3-4-1; Kachegudav,Hyderabad-500027
Hyderabad
ANDHRA PRADESH 
09866894218

dr_govardhan18@yahoo.com 
Dr. Ramesh Madhav Patankar  Shree Hospital  Near Geeta Bhavan Hotel, Ambedkar Garden,Chembur- 71-
Mumbai
MAHARASHTRA 
09820148845

patrameshneuro@yahoo.co.in 
Dr. Ganesh N. Kini  Vimala Neurology Centre & EEG Clinic, G-3 Urmila Complex, Opp. Hotel Malhar, 19th Roa, Chembur, Mumbai-71  ,-
Mumbai
MAHARASHTRA 
982118826

drganeshkini@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Clinical Ethics Forum  Approved 
Lalitha Super Speciality Hospital Ethics Committee  Approved 
SKS Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
  Refractory Epilepsy Suffering From Partial Onset Seizures With or Without Secondary Generalisation 
 
Intervention / Comparator Agent  
Type  Name  Details 
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. 
Comparator Agent  Oxcarbazepine Extended Release  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. 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  Male and female patients between 18 and 65 years of age (both inclusive) with Refractory Epilepsy Suffering From 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. 
 
ExclusionCriteria 
Details  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 component 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) &#61603; 60 ml/min. History of drug abuse and alcohol abuse with last 2 years. Patients taking felbamate, vigabatrin, topiramate, psychotropic drugs, anticholinergic drugs, anti-parkinson medication, &#945;1-antagonist and &#945;2-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 syndrome 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 Women patient of childbearing potential, not practicing medically acceptable (non-hormonal) method of contraception Pregnant or lactating women, children and adolescents below 18 years 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Median percentage reduction in frequency of seizures compared to baseline  Seizure frequency every four weekly. Comparision between end of trail and base line seizure frequency 
 
Secondary Outcome  
Outcome  TimePoints 
Responder Rate (defined as proportion of patients with a minimum of 50% reduction in seizure frequency from 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   Based on seizure frency reduction 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   No Date Specified 
Date of First Enrollment (Global)  19/03/2010 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Brief Summary    
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