MAESTRO-03
What it found
The trial was stopped early because the treatment was not working.
Reason given: Negative efficacy results of the MAESTRO-01 study
This trial finished 17 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Dirucotide
What it measured
Main measures
Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment
24 Months
Disability progression
Other measures (1)
To assess the safety of MBP8298, degree of change in the EDSS scores, effect of MBP8298 on MRI parameters, difference in relapse rates, effect on MSFC, subject's quality of life (MSQoL54) and fatigue (MFIS) after 24 months of treatment
24 Months
Disability progressionRelapsesMRI lesionsFatigueQuality of life (reported by participants)Safety
Who could take part
Progressive MS · 18 to 65
Inclusion Criteria: * Male of female subjects, 18-65 years of age with a diagnosis of SPMS * HLA DR2 and/or DR4 positive * Absence of a relapse in the 3 months prior to baseline * EDSS of 3.0 - 6.5 Exclusion Criteria: * Therapy with Beta-interferon, glatiramer acetate within 3 months or mitoxantrone, cyclophosphamide, methotrexate, azathioprine or any immune modulating or immunosuppressive drugs within 6 months of baseline * Treatment with Tysabri within 2 years of baseline * Females who are breast feeding, pregnant (pregnancy test at baseline) or not using a medically approved method of contraception regularly Other protocol-defined inclusion/exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)
Papers
Loading reviews and guidelines…
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History
Started
Jun 2007
Main results due
Jul 2009
Finished
Sept 2009
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