Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Interferon beta-1b
Interferon alpha/beta receptor agonist
What it measured
Main measures
Magnetic Resonance Imaging (MRI): T2-lesions
At week 104
MRI lesions
Other measures (6)
Further Magnetic Resonance Imaging (MRI) parameters
At week 104
MRI lesionsRelapses
At week 104
RelapsesChanges in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)
At week 104
Disability progressionQuality of life (reported by participants)Hospitalizations
At week 104
Neutralizing antibodies
At week 104
Immune responseAdverse events
At week 104
Safety
Who could take part
Progressive MS · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
Related trials
- STOP-I-SEP
Phase 3 · Running, not recruiting
Still running
- BECAUSE - Betaferon in Early SPMS - SCAndinavian study on USE of double dose
Phase 3 · Stopped early
Stopped early
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