The MAESTRO Study
A Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis
Length of study: 2 years
INCLUSION CRITERIA
In order to be eligible to enter into the study, the subjects must fulfill the following criteria:
1. Male or female subjects, 18-65 years of age
2. HLA DR 2 and/or 4 positive
3. Documented history of SPMS, as defined below:
SPMS for this study is defined as an MS subject for whom there has been a period of at least 3-years from their first clear-cut symptoms of MS, and in the 2 year period prior to enrolment must have documented progression of their pyramidal or cerebellar Kurtzke functional subscores (FSS). (In the absence of documented FSS changes, clinical notes documenting changes consistent with these changes may be acceptable). The subject must fulfill the revised McDonald criteria in order to be eligible for this study. Documentation of the first signs and symptoms of MS and date of diagnosis of SPMS must be available in the subject’s records.
4. Absence of relapse in the 3 months prior to the baseline visit
5. EDSS of 3.0 – 6.5
6. Pyramidal or Cerebellar FSS ≥ 2
7. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements
8. In the Investigator’s opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations.
EXCLUSION CRITERIA
Subjects will not be enrolled in the study if any of the following exclusion criteria are present/apply:
1. Diagnosis of Primary Progressive MS or Relapsing Remitting MS
2. HLA DR 2 and 4 negative
3. EDSS of <3.0 and >6.5
4. Subjects have previously received MBP8298
5. A recent history of malignancy (defined as within 5 years of the diagnosis of the malignancy), with the exclusion of basal cell carcinoma. All subjects with a history of malignancy must be discussed, approved, and a waiver issued by the Sponsor Medical Monitor prior to enrollment and randomization
6. Systemic steroid therapy within 8 weeks prior to the baseline visit (Visit 1), or any other treatment known to be used for putative or experimental MS treatment
7. Therapy with ß-interferon, glatiramer acetate within 3 months or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immunomodulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 months prior to the baseline visit, with the exception of corticosteroids or ACTH for relapse treatment
8. Initiation, change of dose or discontinuation of therapy with 4-AP or 3,4-DAP at any time during the study period
9. History of anaphylactic/anaphylactiod reactions to glatiramer acetate
10. Abnormal laboratory values at the baseline visit deemed by the Investigator to be clinically significant
11. Known allergy to Gadolinium-DTPA
12. Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment e.g. anti-CD4, anti-CD52, , Anti-CD20
13. Treatment with Tysabri™ within the past 2 years
14. High dose treatment i.e. Methotrexate or Cyclophosphamide (anti-cancer doses), bone marrow transplant or immunoablative treatment
15. Treatment at any time with an altered peptide ligand
16. Any conditions that could interfere with the performance of study specific procedures e.g. MRI
17. Known positivity for HIV, Hepatitis B, or Hepatitis C
18. Participation in any other non-MS clinical trial within 30 days prior to baseline, or any investigational MS therapy in the past 6 months
19. Females who are breast feeding, pregnant (pregnancy test at baseline), or not using a medically approved method of contraception regularly
20. Known or suspected current or past alcohol or drug abuse (within the last year)
21. 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
22. Any other condition that, in the Investigator’s opinion, makes the subject unsuitable for participation in the study