Early Secondary Progressive Multiple Sclerosis
Conditions
Interventions
Trade Name: Betaferon
Product Name: Betaferon
Pharmaceutical Form: Powder for solution for injection
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2x250-
Trade N
Sponsors
Schering Nordiska AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 or above, Diagnosis of MS for not less than one year and no more than 10 years, Disease in the SP phase (recorded history of RR disease course followed by progressive deterioration), EDSS score of 3.0-6.0, Estimated deterioration of 1 EDSS score within the last two years, One or more relapses during the last 36 months, Interferon treatment for at least 6 months and with the approved dose (250 mcg e.o.d.) of Betaferon for at least 3 months, Adequate contraception for females of child-bearing potential, Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any other form of MS, Serious acute heart disease, Severe depression or suicide attempt, Serious acute liver, renal or bone marrow dysfunction, Epilepsy not adequately controlled, Any conditions that could interfere with the MRI or any other evaluation, Known allergy to Gadolinium-DTPA, Contraindication to both ibuprofen and paracetamol, Participation in any clinical trial within the past 30 days, Pregnancy or lacatation, Alcohol or drug abuse, Previous randomization during this study, Condition that compromise the patient's ability to understand the patient information, Pretreatment with certain therapies (wash-out periods given), Lack of biological response as measured by MxA PCR at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare a Betaferon 2x250 microgram dose to the 250 microgram dose, given subcutaneously every other day, with regard to efficacy, safety and tolerability in patients with early SPMS.;Secondary Objective: See above;Primary end point(s): Cumulative number of new or enlarging T2-lesions up to week 104 | — |
Countries
Denmark, Sweden
Outcome results
None listed