Determine the efficacy, safety, and tolerability of BG00012 in MS patients.
The study will be divided into two parts: Part 1 will be a 24-week, blinded, placebo-controlled treatment phase followed by Part 2, a 24-week blinded, safety extension phase in which all subjects will receive BG00012.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
260
The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24.
Time frame: Weeks 12, 16, 20, and 24
The secondary endpoints will include measuring the changes in MRIs from baseline until Week 24, changes in other MS measurements q12 weeks, and the annualized relapse rate and proportion of changes at Weeks 24 and 48.
Time frame: Weeks 24 and 48
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Faculty Hospital St. Anne
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Pardupice, Czechia
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Pilsen, Czechia
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Bochum am St. Josef-Hospital
Bochum, Germany
Heinrich-Heine-Universitat
Düsseldorf, Germany
George-August-Universitat Goettigen
Goettigen, Germany
Uzsoki Hospital
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
...and 32 more locations