Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
Phase 3
Withdrawn
- Conditions
- Multiple Sclerosis
- Interventions
- Registration Number
- NCT00313976
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) - Arm 2 Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) -
- Primary Outcome Measures
Name Time Method Magnetic Resonance Imaging (MRI): T2-lesions At week 104
- Secondary Outcome Measures
Name Time Method 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 Relapses At week 104 Further Magnetic Resonance Imaging (MRI) parameters At week 104