An open-label follow-on study to assess the ongoing safety of MBP8298 in subjects with secondary progressive multiple sclerosis
What it found
The trial ended early for another reason (see below).
What it measured
Main measures
An independent pharmacovigilance group will provide safety oversight through an ongoing and regular review of serious adverse events and aggregate laboratory alert values from all subjects to identify any potential new safety data trends. The group will confer at least quarterly with the medical monitor and will notify the sponsor within 24 hours of the observance of any potential new safety find
Safety
Other measures (1)
1. Expanded Disability Status Scale (EDSS) change, measured once every 6 months (prior to each dose) 2. Quality of life, measured once every 6 months (prior to each dose) by Multiple Sclerosis Quality of Life-54 (MSQoL-54). In countries where this tool has not been translated into the local language, the Short Form-36 is used. 3. Relapse rates (each confirmed relapse will be recorded) Brain magn
Disability progressionRelapsesMRI lesionsBrain volume lossQuality of life (reported by participants)
Who could take part
Progressive MS
Inclusion: 1. Completion of treatment and all required evaluations of MBP8298-SP-01(ISRCTN record of this trial at http://www.controlled-trials.com/ISRCTN98373474) 2. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements 3. Subjects must be reliable, compliant, and agree to cooperate with all trial evaluations in the investigators opinion Exclusion: 1. Pregnancy or desire to become pregnant 2. Use of any concomitant disease modifying therapy for Multiple Sclerosis (MS)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Not provided at time of registration
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Linked trials
Refers to
A double-blind placebo-controlled multicenter study to ev…Completed (inferred)
Links found where a registry record names another trial's registry number.
History
Started
Feb 2007
Finished
Jul 2009
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