A Study for Patients With Secondary Progressive Multiple Sclerosis

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: BioMS Technology Corp.

Criteria

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