A double-blind placebo-controlled multicenter study to evaluate the efficacy and safety of MBP8298 in subjects with secondary progressive multiple sclerosis (SPMS)

Completed

• Conditions: Secondary Progressive Multiple Sclerosis; Nervous System Diseases; Multiple sclerosis (MS)

• Registration Number: ISRCTN98373474
• Lead Sponsor: BioMS Technology Corp (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 553

Inclusion Criteria

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. (In the absence of documented FSS changes, clinical notes documenting changes consistent with these changes will be acceptable). The subject must also have experienced at least one acute relapse as part of their diagnosis of Relapsing/Remitting Multiple Sclerosis (RRMS). Only one relapse prior to diagnosis of MS can be in accordance with the McDonald diagnostic criteria as long as cranial magnetic resonance imaging (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

Exclusion Criteria

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., intravenous immunoglobulin [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 adrenocorticotropic hormone (ACTH) for relapse treatment.
6. Initiation of therapy with 4-aminopyridine (4-AP) or 3,4-diaminopyridine (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 human immunodeficiency virus (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 breastfeeding, 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
To compare the clinical efficacy of 500 mg MBP8298 given intravenously every 6 months for a period of 2 years, to placebo, in subjects diagnosed with SPMS who are positive for the HLA DR2 and/or DR4 haplotype. Clinical efficacy is defined as a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by EDSS.