Trial Condition(s):
Multiple Sclerosis
Study to compare double-dose Betaferon to the approved dose, for patients with early secondary progressive Multiple Sclerosis (SPMS)
Bayer Identifier:
91449
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Hillerød Sygehus Hillerød, Denmark, DK-3400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska Universitetssjukhuset Huddinge Stockholm, Sweden, 14186 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska University Hospital Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St Görans Sjukhus Stockholm, Sweden, 11281 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations H:S Rigshospitalet Copenhagen, Denmark, DK-2100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Holstebro Sygehus, sygehus i Ring Holstebro, Denmark, DK-7500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ask Contact, Denmark | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Scandinavian, randomized, rater-blinded study of single and double-dose Betaferon in patients with early secondary progressive multiple sclerosis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Magnetic Resonance Imaging (MRI): T2-lesionsTimeframe: At week 104
Secondary Outcome
- Further Magnetic Resonance Imaging (MRI) parametersTimeframe: At week 104
- RelapsesTimeframe: At week 104
- Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)Timeframe: At week 104
- HospitalizationsTimeframe: At week 104
- Neutralizing antibodiesTimeframe: At week 104
- Adverse eventsTimeframe: At week 104
Additional Information
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