aMICO STUDY
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Mitoxantrone
Compared with
- Glatiramer acetate
Unknown
What it measured
Main measures
-proportion of patients with confirmed progression of disability (progression of at least 1 EDSS point); -difference between final and baseline EDSS (Δ EDSS); - brain atrophy as defined by the change from baseline to termination in normalized brain volume;
Disability progressionBrain volume loss
Who could take part
Progressive MS
Inclusion: -subjects must have a confirmed MS diagnosis as defined by the Revised McDonald criteria (Ann. Neurol. 58:840-846; 2005); - subjects must have a secondary-progressive form of MS (SPMS); -subjects must have a progression of at least 1 point on EDSS scale in the year before the inclusion; -subjects must be ambulatory with EDSS score <6; -subjects must be between 35-55 years of age; -subjects must have a LVEF >50%. Exclusion: -use of immunosuppressive agents within one year prior to baseline; -corticosteroid treatment within 3 month prior to baseline; -subjects with clinically significant or unstable medical or surgical condition that preclude safe and complete study partecipation; -pregnancy; - cardiac abnormalities; - subjects with WBC < 4.0 x 103/μL.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
TO DETERMINE EFFICACY OF COMBINATION THERAPY WITH MITOXANTRONE AND GLATIRAMER ACETATE VERSUS MITOXANTRONE IN SECONDARY-PROGRESSIVE MUTLIPLE SCLEROSIS.
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History
Started
Jan 2011
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