MAESTRO-02
What it found
The trial was stopped early because the treatment was not working.
Reason given: Negative efficacy results of the MAESTRO-01 trial
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
To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes
every 6 mos
Safety
Other measures (7)
Degree of change in Kurtzke Expended Disability Status (EDSS)
every 6mos
Disability progressionBrain atrophy by MRI
every 6mos
MRI lesionsBrain volume lossActivity analysis of T2 and Gadolinium enhancing lesions
every 6mos
MRI lesionsLesion burden
every 6mos
MRI lesionsDegree of change in MS Functional Composite Index (MSFC)
every 6mos
Disability progressionRelapse rates
every 6mos
RelapsesQuality of life as measured by Short Form 36 (SF-36) or MSQoL54
every 6mos
Quality of life (reported by participants)
Who could take part
Progressive MS · 18 to 65
Inclusion Criteria: 1. Subjects participating in this study must have completed treatment and all required evaluations in the previous MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis", 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. In the Investigator's opinion, subjects must be reliable, compliant and agree to cooperate with all trial evaluations. Exclusion Criteria: 1. Use of any concomitant disease modifying therapy for Multiple Sclerosis e.g. ß-interferon, glatiramer acetate or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines. 2. Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements. 3. Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study. 4. Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Feb 2007
Main results due
Sept 2009
Finished
Sept 2009
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