A double-blind, placebo controlled multicentre study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis
- Conditions
- MSMultiple Sclerosis10012303
- Registration Number
- NL-OMON31514
- Lead Sponsor
- ICON Clinical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Male or female subjects, 18-65 years of age,;2. Documented history of SPMS. SPMS is defined as an MS patient who has been diagnosed with MS for at least 3 years, and in the 3 year period prior to enrolment must have documented progression of their pyramidal or cerebellar Kurtzke functional subscores (FSS) in the absence of acute relapses. The subject must also have experienced at least 1 acute relapse as part of their diagnosis of RRMS. Only one relapse prior to diagnosis of MS can be in accordance with the McDonald diagnostic criteria as long as cranial MRI findings consistent with the diagnosis of MS are also present.;3. Absence of relapse in the 3 months prior to baseline,;4. EDSS of 3.5 - 6.5,;5. Pyramidal or Cerebellar FSS >= 3;6. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements,;7. In the Investigator*s opinion, subjects must be reliable, compliant, and agree to cooperate with all trial evaluations,
1. Diagnosis of Primary Progressive MS,
2. Subjects have previously received MBP8298,
3. Any known malignancy, or history of malignancy, with the exclusion of basal cell carcinoma,
4. Steroid therapy within 30 days prior to first dose, or any other treatment known to be used for putative or experimental MS treatment,
5. Therapy with ß-interferon, glatiramer acetate, mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines or plasma exchange within 6 months prior to performance of the first study-specific test, with the exception of corticosteroids or ACTH for relapse treatment.
6. Initiation of therapy with 4-AP or 3,4-DAP.
7. History of anaphylactic/anaphylactoid reactions to glatiramer acetate,
8. Abnormal laboratory values at the Baseline Visit deemed by the Investigator to be clinically significant,
9. Known allergy to Gadolinium-DTPA,
10. Treatment at any time with Cladribine, total lymphoid irradiation, monoclonal antibody treatment e.g. anti-CD4, anti-CD52, anti-VLA4, Anti-CD20,
11. Treatment at any time with an altered peptide ligand,
12. Any conditions that could interfere with the performance of study specific procedures e.g. MRI,
13. Previous randomization to this study,
14. Known positivity for HIV, Hepatitis B, or Hepatitis C,
15. Participation in any other non-MS clinical trial within 30 days prior to performance of the first study specific test (the screening/baseline visit), or any investigational therapy in the past 6 months,
16. Females who are breast feeding, pregnant (pregnancy test at Screening), or not using a medically approved method of contraception regularly.
17. Known or suspected current or past alcohol or drug abuse (within the last year)
18. 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,
19. Any other condition that, in the Investigator*s opinion, makes the subject unsuitable for participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>De primary parameter is the clinical efficacy (worsening of disability = EDSS<br /><br>score) of patients with SPMS and a positive HLA D2/4 haplotype and who are<br /><br>administered with the active medication compared to the same groupe of patients<br /><br>that are administered with the placebo. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- The EDSS score of patients with SPMS with a negative HLA DR2/4 haplotype and<br /><br>who received active medication compared to the same group of patients who<br /><br>received the placebo.<br /><br>- The effect of MBP8298 on several MRI parameters:<br /><br>- activity analysis<br /><br>- Lesion burden<br /><br>- atrophy<br /><br>- Confirmation that MBP8298 induces a immunological tolerance or shipft in<br /><br>functional response profile to MBP epitope (82-98) and determine if this is<br /><br>independent of the HLA subtype.<br /><br>-Determine whether MBP8298 induces a immunological tolerance or a functional<br /><br>shift in the response profile ot other MBP epitopes and other myeline antigens<br /><br>and whether this is dependent on HLA subtype.<br /><br>- To confirm the ratio of HLA DR2/4 positive to HLA DR2/4 negative subjects in<br /><br>the SPMS population.<br /><br>- De safetey of MBP8298 in all patients<br /><br>- To determine if MBP8298 improves the quality of life.</p><br>