To obtain additional safety data in subjects who have previously completed the MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Multiple Sclerosis" Dirucotide is generic name for MBP8298.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
546
500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination
St. Michaels Hospital
Toronto, Ontario, Canada
Copenhagen University Hospital
Copenhagen, Denmark
West Tallinn Central Hospital
Tallinn, Estonia
Terveystalo Turku Kuvantaminen
Turku, Finland
To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes
Time frame: every 6 mos
Degree of change in Kurtzke Expended Disability Status (EDSS)
Time frame: every 6mos
Brain atrophy by MRI
Time frame: every 6mos
Activity analysis of T2 and Gadolinium enhancing lesions
Time frame: every 6mos
Lesion burden
Time frame: every 6mos
Degree of change in MS Functional Composite Index (MSFC)
Time frame: every 6mos
Relapse rates
Time frame: every 6mos
Quality of life as measured by Short Form 36 (SF-36) or MSQoL54
Time frame: every 6mos
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Heinrich Heine Universitaets
Düsseldorf, North Rhine-Westphalia, Germany
Vecmilgravis Hospital
Riga, Latvia
Maaslandziekenhuis
Sittard, Netherlands
Hospital Duran I Reynals
Barcelona, Spain
Karolinska Universitetssjukhus
Stockholm, Sweden
Walton Hospital
Liverpool, United Kingdom