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

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

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).

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.

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