MAESTRO-01
What it found
The main measure did not show a significant benefit.
“Results There were no significant differences between treatment groups in either the primary or secondary endpoints.”Read by software from the paper's abstract
time to progression by ≥1.0 EDSS point (or 0.5 point if baseline EDSS was 5.5 or higher), confirmed 6 months later · 2 years
Total participants: 612
Read by software from the paper's abstract
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
Placebo or sham
- Placebo
What it measured
Main measures
Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS).
baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
Disability progressionThe primary endpoint is a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by EDSS.
Disability progression
Other measures (7)
degree of change in EDSS
baseline, 24mos
Disability progressionBrain Atrophy by MRI
baseline, 12mos, 24mos
MRI lesionsBrain volume lossActivity analysis of T2 and Gadolinium enhancing lesions
12mos and 24mos
MRI lesionsLesion burden
12mos and 24mos
MRI lesionsDegree of change in MS Functional Composite Index (MSFC)
baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos
Disability progressionRelapse rates
baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos
RelapsesQuality of life as measured by Short Form 36 (SF-36) or MSQoL54
baseline, 6mos, 12mos, 18mos, 24mos
Quality of life (reported by participants)
Who could take part
Progressive MS · 18 to 65
Inclusion Criteria: * Documented history of SPMS * Absence of relapse in the 3mos prior to baseline * EDSS of 3.5 - 6.5 * Pyramidal or Cerebellar FSS greater than or equal to 3 * A cohort of 100 HLA DR2/4 negative patients is required. Once enrollment to this cohort is complete, all further patients are required to be HLA DR2/4 positive. * Informed consent * Subject reliability and compliance Exclusion Criteria: * Diagnosis of Primary Progressive MS * Subjects have previously received MBP8298 * Recent history of malignancy, with the exclusion on basal cell carcinoma. * Steroid therapy within 30 days prior to first study specific procedure or any other treatment known to be used for putative or experimental MS treatment * Therapy with beta-interferon, glatiramer acetate within 3 mos or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 mos prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment. * Initiation or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period. * History of anaphylactic/anaphlactoid reactions to glatiramer acetate * Abnormal lab values at the Screening Visit deemed by the Investigator to be clinically significant * Known allergy to Gadolinium-DTPA * Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment * Treatment at any time wtih an altered peptide ligand * Any conditions that could interfere with the performance of study specific procedures e.g.MRI * Previous randomization to this study * Known positivity for HIV, Hepatitis B, or Hepatitis C * Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test or any investigational therapy in the past 6 mos. * Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly * Known or suspected current or past alcohol or drug abuse (within the last year) * 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 * Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to determine whether MBP8298 is effective and safe in the treatment secondary progressive multiple sclerosis. Dirucotide is generic name for MBP8298.
Papers
Loading reviews and guidelines…
Related trials
- C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen R…
Phase 1 / Phase 2 · Not yet recruiting
Still running
- MS-tolDC_2a
Phase 2 · Not yet recruiting
Still running
- Study of NG01 Cell Therapy in Secondary Progressive Multi…
Phase 2 · Not yet recruiting
Still running
- BOBCAT
Phase 1 · Recruiting
Still running
- MAESTRO-4MS
Phase 1 · Recruiting
Still running
- CYTB323R12101
Phase 1 / Phase 2 · Running, not recruiting
Still running
History
Started
Dec 2004
Main results due
May 2009
Finished
May 2009
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error