Status:
WITHDRAWN
Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
Lead Sponsor:
Bayer
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Scleros...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00313976
Last Update
March 10 2015
Active Locations (7)
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1
Ask Contact, Denmark
2
Copenhagen, Denmark, DK-2100
3
Hillerød, Denmark, DK-3400
4
Holstebro, Denmark, DK-7500