Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) (Drug); Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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).
Clinical Details
Official title: A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Magnetic Resonance Imaging (MRI): T2-lesions
Secondary outcome: Further Magnetic Resonance Imaging (MRI) parametersRelapses Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS) Hospitalizations Neutralizing antibodies Adverse events
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
ask Contact, Denmark
Copenhagen DK-2100, Denmark
Hillerød DK-3400, Denmark
Holstebro DK-7500, Denmark
Stockholm 11281, Sweden
Stockholm 14186, Sweden
Stockholm 171 76, Sweden
Additional Information
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Last updated: March 9, 2015
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