A clinical trial to determine the efficacy and safety of BG00012 in patients with relapsing remitting multiple sclerosis.

Phase 3

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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.
Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have relapsing-remitting disease course.

Exclusion Criteria

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.
Pregnant or nursing women.
Other protocol-defined inclusion/exclusion criteria may apply.

Primary Outcome Measures

Name	Time	Method
To determine if BG00012 is effective in reducing the proportion of relapsing subjects at 2 years.	2 years

Secondary Outcome Measures

Name	Time	Method
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

Locations (23): Post Graduate Institute of Medical Education & Research
🇮🇳
Chandigarh, CHANDIGARH, India
502, Dept. of neurology, 5th Floor Academic Block, G B Pant Hospital
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Delhi, DELHI, India
Amrita Institute of Medical Sciences
🇮🇳
Kozhikode, KERALA, India
Apollo Gleneagles Hospitals
🇮🇳
Kolkata, WEST BENGAL, India
B. P. Poddar Hospital and Medical research Limited
🇮🇳
Kolkata, WEST BENGAL, India
CMC Ludhiana
🇮🇳
Ludhiana, PUNJAB, India
Deenanathy Mangeshkar Hospital and Research Centre
🇮🇳
Pune, MAHARASHTRA, India
DMCH Hospital
🇮🇳
Ludhiana, PUNJAB, India
Jehangir Hospital
🇮🇳
Pune, MAHARASHTRA, India
Justice K S Hegde Charitable Hospital
🇮🇳
Bangalore, KARNATAKA, India
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Post Graduate Institute of Medical Education & Research
🇮🇳Chandigarh, CHANDIGARH, India
Dr Dheeraj Khurana
Principal investigator
919914209695
dherajk@yahoo.com