REFCTRI/2009/000668
CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Sat, 01 Oct 2016 10:28:46 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
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
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.
Scientific Title of
Study
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
NIL
NIL
Details of Principal
Investigator or overall
Name
Trial Coordinator
Designation
(multi-center study)
Affiliation
Details Contact
Person (Scientific
Query)
Details of Principal Investigator
Dr. Renu Jain
Address
Torrent Research Centre, Vill. Bhat, Dist. Gandhinagar, PIN-382428,
Gujarat
Gandhinagar
GUJARAT
382428
India
Phone
(079)23969100 Ext. 206
Fax
(079)23969135
Email
renujain@torrentpharma.com
Details Contact Person (Scientific Query)
Name
Dr. Renu Jain
Designation
Affiliation
NIL
Address
Torrent Research Centre, Vill. Bhat, Dist. Gandhinagar, PIN-382428,
Gujarat
Gandhinagar
GUJARAT
382428
India
Phone
(079)23969100 Ext. 206
Fax
Email
Details Contact
Person (Public Query)
renujain@torrentpharma.com
Details Contact Person (Public Query)
Name
Dr. Renu Jain
Designation
Affiliation
Address
Torrent Research Centre, Vill. Bhat, Dist. Gandhinagar, PIN-382428,
Gujarat
Gandhinagar
GUJARAT
page 1 / 5
REFCTRI/2009/000668
CTRI Website URL - http://ctri.nic.in
382428
India
Phone
(079)23969100 Ext. 206
Fax
Email
Source of Monetary or
Material Support
renujain@torrentpharma.com
Source of Monetary or Material Support
> Torrent Research Centre, Torrent Pharmaceuticals Ltd.
Primary Sponsor
Primary Sponsor Details
Name
Dr. Renu Jain
Address
Type of Sponsor
Details of Secondary
Sponsor
Name
Countries of
Recruitment
List of Countries
Sites of Study
Name of Principal
Investigator
Name of Site
Site Address
Dr. Rajendra Duggani
#457/1B Vivekanand
Hospital Road,
Deshpande Nagar,
Hubli-580029
,Not Applicable
N/A
Dr. Anirudh Apte
205, 2nd Floor, Kiran
,Chambers, Opp.
Not Applicable
J.K.Tower, Ring Road, N/A
Surat
Dr. Ravindra Lodha
4, Nalkung Society,
Opp. Rajasthan
Hospital, Nr. Civil
Hospital gate No. 1,
Shahibaug,
Ahmedabad
,Not Applicable
N/A
Dr. Bhupendra
Chaudhary
4,5,6, Shiva Complex,
Near Nanak Chandra
Degree College, Purbi
Kachari (E.K.Road),
Meerut
,Not Applicable
N/A
Dr. Atul Agarwal
55, Ravindra Palli,
Faizabad Road,
Lucknow-226016
,Not Applicable
N/A
Dr. B.S Keshava
City Neuro Centre,
483/4, Kanti Complex,
Agrahara, Near JSS
Hospital Mysore 570004
,Not Applicable
N/A
Dr. K.S Anand
Dr. Ram Manohar Lohia ,Hospital & PGIIMER,
Not Applicable
GGS IP University, New N/A
Delhi-110001
Dr. Ganesh Kini
G-3, Urmila Complex,
Opp. Hotel Malhaar,
19th Road, Chembur,
Mumbai-71
,Not Applicable
N/A
Dr. Bashir Ahmadi
M-4, Mahakant
,-
Address
Dr. Sushil Kumar Anand
India
Phone/Fax/Email
page 2 / 5
REFCTRI/2009/000668
CTRI Website URL - http://ctri.nic.in
Details of Ethics
Committee
Building, Mezzanine
Floor, Opp.
V.S.Hospital,
Ellisbridge,
Ahmedabad-380006
Not Applicable
N/A
Dr. R. Umashankar
Manasvi Specialists, #
66, 14th cross,
Malleswaram,
Bangalore-560003
,Not Applicable
N/A
Dr. Dharmesh Patel
Neuro Care Clinic &
Research Centre, 3rd
floor,Nr. Usmanpura
underbridge,
Naranpura,
Ahmedabad-13
,Not Applicable
N/A
Dr. Bhavin Upadhyay
Neuro Care Clinic,
,advanced
Not Applicable
Electrophysiology Lab N/A
& Physiotherapy
Centre, Kharivav Road,
Nr. G.P.O, Dandia
Bazar, Baroda-1
9825156456
docbhavin@gmail.com
Dr. S.K Poddar
Neurology Centre,
Durgakund, Varanasi 221005
,Not Applicable
N/A
Dr. Ajay Vyas
Sun Flower Neuro Care ,Centre,
Not Applicable
N/A
Name of Committee
Approval Status
Date of Approval
Is Independent Ethics
Committee?
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Clinical Ethics Forum
Approved
No Date Specified
Not Available
Dr. RML Hospital, New Approved
Delhi
No Date Specified
Not Available
Regulatory Clearance
Status from DCGI
Status
Date
Approved/Obtained
No Date Specified
Health Condition /
Problems Studied
Health Type
Condition
Intervention /
Comparator Agent
Type
Name
Details
Intervention
Lacosamide IR formulations
to be started with100mg/day
Patients with refractory epilepsy suffering from
partial onset seizures with or without secondary
generalization.
page 3 / 5
REFCTRI/2009/000668
CTRI Website URL - http://ctri.nic.in
and uptiratrated to a maxi of
400mg/day
Comparator Agent
Levetiracetam IR formulation
Inclusion Criteria
to be started with1000mg/day
and uptiratrated to a maxi of
2000mg/day
Inclusion Criteria
Age From
Age To
Gender
Details
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
Exclusion Criteria
Details
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
Method of Generating Computer generated randomization
Random Sequence
Method of
Concealment
Other
Blinding/Masking
Open Label
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
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
Target Sample Size
Total Sample Size=200
Sample Size from India=
Phase of Trial
Phase 3
Date of First
No Date Specified
page 4 / 5
REFCTRI/2009/000668
CTRI Website URL - http://ctri.nic.in
Enrollment (India)
Date of First
Enrollment (Global)
14/09/2009
Estimated Duration of Years=0
Trial
Months=7
Days=0
Recruitment Status of Completed
Trial (Global)
Recruitment Status of
Trial (India)
Publication Details
Brief Summary
page 5 / 5
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