A Study for Patients With Secondary Progressive Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Placebo Controlled Multicentre Study To Evaluate The Efficacy And Safety Of MBP8298 In Subjects With Secondary Progressive Multiple Sclerosis

Conditions
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Secondary Progressive Multiple Sclerosis

Intervention / Treatment
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* Drug: dirucotide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dirucotide<br> | Drug: dirucotide<br>* 500mg, intravenous, dosed once every six months for 18 months<br>* Other names: LY2820671;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* intravenous, once every six months for 18 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in the time to worsening of disability by Kurtzke Expended Disability Status (EDSS). |  | baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of change in EDSS |  | baseline, 24mos | 
| Brain Atrophy by MRI |  | baseline, 12mos, 24mos | 
| Activity analysis of T2 and Gadolinium enhancing lesions |  | 12mos and 24mos | 
| Lesion burden |  | 12mos and 24mos | 
| Degree of change in MS Functional Composite Index (MSFC) |  | baseline, 3mos, 6mos, 9mos, 12mos, 15mos, 18mos, 21mos, 24mos | 
| Relapse rates |  | baseline, 3mos, 6mos, 9mos, 12mos, 15mos,18mos, 21mos, 24mos | 
| Quality of life as measured by Short Form 36 (SF-36) or MSQoL54 |  | baseline, 6mos, 12mos, 18mos, 24mos |