Secondary Progressive Multiple Sclerosis
Conditions
Brief summary
To obtain additional safety data in subjects who have previously completed the MBP8298-01 study A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Multiple Sclerosis Dirucotide is generic name for MBP8298.
Interventions
DRUGdirucotide
500mg, intravenous, every 6mos until regulatory approval, denial or sponsor termination
Sponsors
BioMS Technology Corp.
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects participating in this study must have completed treatment and all required evaluations in the previous MBP8298-01 study A Double Blind Placebo Controlled Multi-Centre Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis, 2. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial in accordance with regulatory requirements, 3. In the Investigator's opinion, subjects must be reliable, compliant and agree to cooperate with all trial evaluations.
Exclusion criteria
1. Use of any concomitant disease modifying therapy for Multiple Sclerosis e.g. ß-interferon, glatiramer acetate or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines. 2. 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. 3. Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study. 4. Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess clinically significant effects of MBP8298 synthetic peptide in all subjects by collecting adverse event, ECG, laboratory, and physical exam outcomes | every 6 mos |
Secondary
| Measure | Time frame |
|---|---|
| Degree of change in MS Functional Composite Index (MSFC) | every 6mos |
| Relapse rates | every 6mos |
| Quality of life as measured by Short Form 36 (SF-36) or MSQoL54 | every 6mos |
| Lesion burden | every 6mos |
| Brain atrophy by MRI | every 6mos |
| Activity analysis of T2 and Gadolinium enhancing lesions | every 6mos |
| Degree of change in Kurtzke Expended Disability Status (EDSS) | every 6mos |
Countries
Canada, Denmark, Estonia, Finland, Germany, Latvia, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed