The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive multiple sclerosis. Dirucotide is generic name for MBP8298.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
596
500mg, intravenous, dosed once every six months for 18 months
intravenous, once every six months for 18 months
St. Michaels Hospital
Toronto, Ontario, Canada
Copenhagen University Hospital
Copenhagen, Denmark
West Tallinn Central Hospital
Tallinn, Estonia
Terveystalo Turku Kuvantaminen
Turku, Finland
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).
Time frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
degree of change in EDSS
Time frame: baseline, 24mos
Brain Atrophy by MRI
Time frame: baseline, 12mos, 24mos
Activity analysis of T2 and Gadolinium enhancing lesions
Time frame: 12mos and 24mos
Lesion burden
Time frame: 12mos and 24mos
Degree of change in MS Functional Composite Index (MSFC)
Time frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos
Relapse rates
Time frame: baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
Time frame: baseline, 6mos, 12mos, 18mos, 24mos
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Heinrich Heine Universitaets
Düsseldorf, Germany
Vecmilgravis Hospital
Riga, Latvia
Maaslandziekenhuis
Sittard, Netherlands
Hospital Duran I Reynals
Barcelona, Spain
Karolinska Universitetssjukhus
Stockholm, Sweden
Walton Hospital
Liverpool, United Kingdom