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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Interferon beta-1b; Interferon-beta; Interferons

Criteria

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