MS Multiple Sclerosis
Conditions
Interventions
500 mg MBP8298 will be administered intravenously 8 times once per 6 months for
a period of 18-48 months.
Sponsors
ICON Clinical Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 |
|---|---|
| Adverse Events Blood pressure and heart rate 12-Lead ECG*s Clinical Chemistry and Haematology Changes in physical examination results | — |
Secondary
| Measure | Time frame |
|---|---|
| The EDSS is the most commonly accepted numerical measure of the clinical status of an MS subject. The EDSS is an ordinal variable ranging from 0-10 in increments of 0.5. The clinical efficacy of MBP8298 will be assessed by evaluating the time to progression as measured by EDSS in subjects receiving MBP8298 as an IV injection every 6 months. Degree of change in EDSS, mean EDSS change, and change in area under the EDSS curve. Relapse rates. Assessment of efficacy as measured by the MSFC. Differences in subject Quality of Life as measured by the MSQoL54/SF-36. MRI parameters, all subjects will continue to have MRI*s performed with and without gadolinium enhancement on an annual basis. MRI*s will be brain only | — |
Countries
Netherlands
Outcome results
None listed