Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
* Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)<br>* 250 micrograms every other day, subcutaneously for 104 weeks<br>|
| Experimental: Arm 2<br> | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)<br>* 2x250 micrograms every other day, subcutaneously for 104 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic Resonance Imaging (MRI): T2-lesions |  | At week 104 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further Magnetic Resonance Imaging (MRI) parameters |  | At week 104 | 
| Relapses |  | At week 104 | 
| Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS) |  | At week 104 | 
| Hospitalizations |  | At week 104 | 
| Neutralizing antibodies |  | At week 104 | 
| Adverse events |  | At week 104 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Early secondary progressive Multiple Sclerosis