Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Early secondary progressive Multiple Sclerosis
Brief summary
The purpose of the study is to evaluate if the higher dose can give greater efficacy without negative impact on the adverse event profile for patients with early secondary progressive Multiple Sclerosis (SPMS).
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Interventions
250 micrograms every other day, subcutaneously for 104 weeks
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of MS for no less than one year and no longer than ten years * Disease in the secondary progressive (SP) phase * At least one relapse the last 3 years * Treatment with an interferon for at least 6 months and with Betaferon for at least 3 months
Exclusion criteria
* Serious or acute heart disease * Severe depression * Serious or acute liver, kidney or bone marrow dysfunction * Epilepsy not adequately treated * Pregnancy or lactation * Alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnetic Resonance Imaging (MRI): T2-lesions | At week 104 |
Secondary
| Measure | Time frame |
|---|---|
| Relapses | At week 104 |
| Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS) | At week 104 |
| Further Magnetic Resonance Imaging (MRI) parameters | At week 104 |
| Neutralizing antibodies | At week 104 |
| Adverse events | At week 104 |
| Hospitalizations | At week 104 |
Countries
Denmark, Sweden
Outcome results
None listed