| CTRI Number |
CTRI/2009/091/000088 [Registered on: 17/11/2009] |
| Last Modified On: |
24/07/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to determine the efficacy and safety of BG00012 in patients with relapsing remitting multiple sclerosis. |
|
Scientific Title of Study
|
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 109MS301 |
Protocol Number |
| 2006-003696-12 |
EudraCT |
| NCT00420212 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta Madaan |
| Designation |
|
| Affiliation |
|
| Address |
Biogen Idec Biotech India Pvt. Ltd.
14th floor, Vatika Tower B, Sector 54
Gurgaon
HARYANA
122002
India |
| Phone |
0124 4572314 |
| Fax |
0124 4572333 |
| Email |
mamta.madaan@biogenidec.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Amish Vora |
| Designation |
|
| Affiliation |
Medical Director |
| Address |
Biogen Idec Biotech India Pvt. Ltd.
14th floor, Vatika Tower B, Sector 54
Gurgaon
HARYANA
122002
India |
| Phone |
0124 4572315 |
| Fax |
0124 4572333 |
| Email |
amish.vora@biogenidec.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mandeep Kaushal |
| Designation |
|
| Affiliation |
|
| Address |
Biogen Idec Biotech India Pvt. Ltd.
14th floor, Vatika Tower B, Sector 54
Gurgaon
HARYANA
122002
India |
| Phone |
0124-4572351 |
| Fax |
0124-4572333 |
| Email |
mandeep.kaushal@biogenidec.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Biogen Idec |
| Address |
Biogen IdecInnovation House70 Norden RoadMaidenheadBerkshireSL4 6AY |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 23 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dheeraj Khurana |
Post Graduate Institute of Medical Education & Research |
Post Graduate Institute of Medical Education & Research
Dept. of Neurology
Sec 21
Chandigarh
Chandigarh
CHANDIGARH |
919914209695
911722741279
dherajk@yahoo.com |
| Dr. M M Mehndiratta |
502, Dept. of neurology, 5th Floor Academic Block, G B Pant Hospital |
,-110002
New Delhi
DELHI |
91 (0) 11 23234350
91 (0) 11 23234350
mmmresearch@gmail.com |
| Dr Suresh Kumar |
Amrita Institute of Medical Sciences |
Amrita Institute of Medical Sciences
Amrita Lane
Kochi Elamakkara
India
Kozhikode
KERALA |
919447708161
9104842802135
rsureshkumar@aims.amrita.edu |
| Dr Amitabha Ghosh |
Apollo Gleneagles Hospitals |
Apollo Gleneagles Hospitals
58 Canal Circular Road
Kolkata
West Bangal
Kolkata
WEST BENGAL |
919830119686
9103323201739
amitabha.ghosh@yahoo.co.in |
| Dr. S C Mukherjee |
B. P. Poddar Hospital and Medical research Limited |
71/1 Himuyan Kabir Sarani, Block G, New Allapore,-700053
Kolkata
WEST BENGAL |
91 9830413617
91 (0) 33 24577009
drscmukherjee@gmail.com |
| Dr Yashpal Singh |
CMC Ludhiana |
Department of Neurology, CMC and Hospital, Brown Road, Ludhiana -141008, Punjab
Ludhiana
PUNJAB |
9814814044
911612220850
neuroyash@yahoo.com |
| Dr. Rahul Kulkarni |
Deenanathy Mangeshkar Hospital and Research Centre |
Off Karve Road, Erandwane,-411004
Pune
MAHARASHTRA |
91 (0) 20 66023000 Extn: 1058
91 (0) 20 66023012
rahulneuro@vsnl.net |
| Dr Gagandeep Singh |
DMCH Hospital |
DMCH
Department of Neurology, 3rd Floor, EEG Lab
Tagore Nagar Civil Lines Ludhiana
Ludhiana
PUNJAB |
919815500720
911612308383
gagandeep_si@yahoo.co.uk |
| Dr N R Ichaporia |
Jehangir Hospital |
Jehangir Hospital
32 Sassoon Road
Pune
Pune
MAHARASHTRA |
919822032969
912026059319
nri_neuro@hotmail.com |
| Dr. Lekha Pandit |
Justice K S Hegde Charitable Hospital |
Deralakate,-
Bangalore
KARNATAKA |
91 9845084343
91 (0) 824 2203747
panditmng@gmail.com |
| Dr. K Vijayan |
Kovai Medical Centre and Hospital Limited |
3209, Avanashi Road,-641014
|
91 9842155101
91(0) 422 2627782
kalyani_vijayan@rediffmail.com |
| Dr Rangasetty Srinivasa |
M S Ramaiah Memorial Hospital |
M S Ramaiah Memorial Hospital
New Bel road
MSRIT POST
Bangalore
Bangalore
KARNATAKA |
919448040589
918040528402
drrsrinivasa@hotmail.com |
| Dr Shankara Nellikunja |
Mallikatta Neuro Center |
Mallikatta Neuro Center
Opp. Mallikatta Circle
Kadri Mangalore
Karnataka
Udupi
KARNATAKA |
919845080925
918244255925
shankarmnl@hotmail.com |
| Dr J D Mukherjii |
Max Super Speciality Hospital |
Max Super Speciality Hospital
1 Press Enclave Road
Saket New Delhi
South
DELHI |
911166116666
911166116677
jd.mukherji@maxhealthcare.com |
| Dr Neeta Mehta |
Neeta Mehta Clinic |
Neeta Mehta Clinic
D-502, 5th Floor
Rizvi Nagar, Milan Subway Junction
S V Road
Mumbai
Mumbai
MAHARASHTRA |
919869033053
912226184448
drneetamehta@gmail.com |
| Dr Shalin Shah |
Neurology Clinic |
Neurology Clinic
206 7 8 Sangini Complex
Near Parimal Railway Crossing
Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT |
917926467467
917926405758
drshalinshah@yahoo.co.in |
| Dr. Madhuri Behari |
Neurology Department, AIIMS |
Ansari Nagar,-110029
New Delhi
DELHI |
91 9868398262
91 (0) 11 26588166
madhuribehari@hotmail.com |
| Dr. A K Meena |
Nizams Institute of Medical Sciences |
,-
Hyderabad
ANDHRA PRADESH |
91 (0) 40 66461365
91 (0) 40 66461365
nimsneurostudies@gmail.com |
| Dr. Sudhir Kothari |
Poona Hospital and Research Centre |
27 sadashiv Peth,-411030
Pune
MAHARASHTRA |
91 9822719440
91 (0) 20 24320681
sudhirkothari@gmail.com |
| Dr PK Sethi |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital
Old Rajinder Nagar
Delhi
Central
DELHI |
911142551450
911145041726
sethiprahlad@hotmail.com |
| Dr Pahari Ghosh |
Sri Aurobindo Sevakendra |
Sri Aurobindo Sevakendra
1H, Gariahat Road (South)
Jodhpur Park
Kolkota
Kolkata
WEST BENGAL |
919831023296
913324990059
pahari_ghosh@vsnl.net |
| Dr. Arun Shah |
TNMC & BYL Nair Ch. Hospital |
Dr. A L Nair Road, Mumbai Central,-400008
Mumbai
MAHARASHTRA |
91 (0) 22 23027579
91 (0) 22 23020296
nairneurology@gmail.com |
| Dr. Shamsher Dwivedee |
VIMHANS |
No. 1 Institutional Area, Nehru Nagar,-110065
New Delhi
DELHI |
91 9810084300
91 (0) 11 29849036
sdclinical@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 22 |
| Name of Committee |
Approval Status |
| Kshema Ethics Committee, K S Hegde Medical Academy, Nithyanand Nagar, Deralakatte-575018; Mangalore, Karnataka, India. |
Approved |
| B.Y.L. Nair CH. Hospital & T. N. Medical Collage, 2nd Floor, Dept. of Pharmacology, Dr. A. L. Nair Road, Mumbai-400 008 |
Approved |
| Ethical Committee, B P Poddar Hospital and Medical Research Ltd, 71/1 Humanyun Kabir Sarani, Block G, New Alipore, Kolkatta ? 700 053 |
Approved |
| Ethical review Board MS Ramahia |
Approved |
| Ethics Committee, VIMHANS, 1 Institutional Area, Nehru Nagar, New Delhi ? 110 065 |
Approved |
| Ethics Committee,Poona Hospital and Research Centre, 27-Sadahiv Peth, Pune- 411030, Maharastra, India |
Approved |
| Hirabai Cowasgi Jehangir Medical research Institute |
Approved |
| Independent Ethics Committee |
Approved |
| Institute Ethics Committee |
Approved |
| Institute Ethics Committee, All India Institute of Medical Sciences , Ansari Nagar, New Delhi-110029 India |
Approved |
| Institutional Ethics Committee Amrita Institute of Medical Sceinces and Research |
Approved |
| Institutional Ethics Committee Apollo Gleneagles Kolkotta |
Approved |
| Institutional Ethics Committee CMC Ludhiana |
Approved |
| Institutional Ethics Committee DMC Ludhiana |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Centre, Erandwane, Pune- 411004, India. |
Approved |
| Institutional Ethics committee, Nizam?s Institute of Medical Sciences, Punjagutta, Hyderabad |
Approved |
| KMCH Ethics Committee, Kovai Medical Center and Hospitals,3209, Avanashi Road, Coimbatore-641014 |
Approved |
| Malikatta Ethical Committee |
Approved |
| MAMC Society for Promotion of Medical Research, Academics block, G B pant Hospital, N Delhi ? 110 002 |
Approved |
| Max Health Care Ethics Committee |
Approved |
| Sujlam, Independent Ethics Committee |
Approved |
| The Ethics Committee of Sri Aurobindra Seva Kendra |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Relapsing Remitting Multiple Sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BG00012 |
240mg capsule BID |
| Intervention |
BG00012 |
240mg capsule TID |
| Comparator Agent |
Placebo |
to match |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
a). Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
b). Aged 18 to 55 years old, inclusive, at the time of informed consent.
c). Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
d). Must have a baseline EDSS between 0.0 and 5.0, inclusive.
e). Must have relapsing-remitting disease course. |
|
| ExclusionCriteria |
| Details |
a). Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
b). Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
c). Pregnant or nursing women.
Other protocol-defined inclusion/exclusion criteria may apply. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine if BG00012 is effective in reducing the proportion of relapsing subjects at 2 years. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine if BG00012 decreases the number of brain lesions and slows time to progression. To determine the safety and tolerability of BG00012, and the effect it may have on tests and evaluations used to assess MS. |
2 years |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1011"
Sample Size from India="71"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/03/2007 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, multicenter, double blind, placebo controlled, dose comparison study that will be conducted in North America, Europe and rest of world. The primary objective of this study is to determine whether BG00012, is effective in reducing the proportion of relapsing subjects at 2 years.
The countries participating are United States, Australia, Austria, Belgium, Republic of Srpksa, Canada, Croatia, Czech Republic, France, Germany, Greece, Guatemala, India, Israel, Italy, , Mexico, The Former Yugoslav Republic of Macedonia, Moldova, Netherlands, New Zealand, Poland, Romania, Serbia, Slovakia, South Africa, Switzerland, Ukraine, United Kingdom.
India has recruited 114 patients in this study. |