Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
With
BioMS Technology Corp.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
