Clinical Trial Details (PDF Generation Date :- Sat, 24 Nov 2018 11:16:02 GMT) CTRI Number CTRI/2009/091/000668 [Registered on: 11/01/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Randomized, Parallel Group, Active Controlled Trial A comparative Clinical trial to study the effect of two drugs, lacosamide & levetiracetam in patients with refractory epilepsy suffering from partial onset seizures with or without secondary generalization. A Multicenter, Randomized Open-Label, Comparative, Prospective Clinical Trial to Investigate Efficacy and Safety of Lacosamide versus Levetiracetam as an Adjunctive Treatment in Patients With Refractory Epilepsy Suffering From Partial Onset Seizures With or Without Secondary Generalization. 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) Details of Principal Investigator Fax (079)23969135 Torrent Research Centre, Vill. Bhat, Dist., PIN-, Details Contact Person (Scientific Query) Fax Torrent Research Centre, Vill. Bhat, Dist., PIN-, Details Contact Person (Public Query) Torrent Research Centre, Vill. Bhat, Dist., PIN-, page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Source of Monetary or Material Support > Torrent Research Centre, Torrent Pharmaceuticals Ltd. Type of Sponsor Dr. Sushil Kumar Anand List of Countries of Principal Investigator Dr. Rajendra Duggani Dr. Anirudh Apte Dr. Ravindra Lodha Dr. Bhupendra Chaudhary Dr. Atul Agarwal Dr. B.S Keshava Dr. K.S Anand Dr. Ganesh Kini Primary Sponsor Details of Site Site Phone/Fax/ #457/1B Vivekanand Hospital Road, Deshpande Nagar, Hubli-580029 205, 2nd Floor, Kiran Chambers, Opp. J.K.Tower, Ring Road, Surat 4, Nalkung Society, Opp. Rajasthan Hospital, Nr. Civil Hospital gate No. 1, Shahibaug, Ahmedabad 4,5,6, Shiva Complex, Near Nanak Chandra Degree College, Purbi Kachari (E.K.Road), Meerut 55, Ravindra Palli, Faizabad Road, Lucknow-226016 City Neuro Centre, 483/4, Kanti Complex, Agrahara, Near JSS Hospital Mysore - 570004 Dr. Ram Manohar Lohia Hospital & PGIIMER, GGS IP University, New Delhi-110001 G-3, Urmila Complex, Opp. Hotel Malhaar, 19th Road, Chembur, Mumbai-71 Dr. Bashir Ahmadi M-4, Mahakant page 2 / 5
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Building, Mezzanine Floor, Opp. V.S.Hospital, Ellisbridge, Ahmedabad-380006 Dr. R. Umashankar Manasvi Specialists, # 66, 14th cross, Malleswaram, Bangalore-560003 Dr. Dharmesh Patel Dr. Bhavin Upadhyay Dr. S.K Poddar Dr. Ajay Vyas Neuro Care Clinic & Research Centre, 3rd floor,nr. Usmanpura underbridge, Naranpura, Ahmedabad-13 Neuro Care Clinic, advanced Electrophysiology Lab & Physiotherapy Centre, Kharivav Road, Nr. G.P.O, Dandia Bazar, Baroda-1 Neurology Centre, Durgakund, Varanasi - 221005 Sun Flower Neuro Care Centre, 9825156456 docbhavin@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Dr. RML Hospital, New Delhi Status Approved/Obtained Health Type Approved No Date Specified Not Available Date No Date Specified Condition Patients with refractory epilepsy suffering from partial onset seizures with or without secondary generalization. Type Details Intervention Lacosamide IR formulations to be started with100mg/day page 3 / 5
Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking and uptiratrated to a maxi of 400mg/day Comparator Agent Levetiracetam IR formulation to be started with1000mg/day and uptiratrated to a maxi of 2000mg/day Age From Age To Gender Details Details Computer generated randomization Other Open Label Inclusion Criteria Male and female patients between 17 and 70 years of age (both inclusive) with confirmed refractory epilepsy suffering from partial onset seizures with or without secondary generalization and maintaining a stable dose regimen of at least one Anti-epileptic drug (AED) for one month before screening Documented history of patients with minimum 2 seizures in past two months, with at least 1 seizure in last one month. Exclusion Criteria Patients unable/unwilling to give informed written consent Patients with seizures occurring in clusters Patients with Status Epilepticus within 3 months of enrollment Patients with history of non-epileptic seizures Patients with known allergic reaction or intolerance to study drugs and /or excipients Patients with liver enzymes more than 2.5X the normal value and/or bilirubin more than 1.5X the normal value and/or serum creatinine more than the upper limit of the normal value 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 investigational 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 17 years Primary Outcome Outcome Timepoints Responder Rate (defined as proportion of patients with a minimum of 50% reduction in seizure frequency from baseline) Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Median percentage reduction in frequency of seizures compared to 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=200 Sample Size from = No Date Specified page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 14/09/2009 Years=0 Months=7 Days=0 Completed page 5 / 5