Multiple Sclerosis, with primary and secondary progressive courses. MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Trade Name: NeoRecormon
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Solu-Medrol
CAS Number: 2375033
Current Sponsor code: Pfizer
Other descriptive name: METHYLPREDNISOLONE SODIUM S
Sponsors
Danish Multiple Sclerosis Research Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 19 and 55 years inclusive. Multiple Sclerosis (MS) according to the revised McDonald criteria: either primary progressive MS or secondary progressive MS without relapses during the last one year. MS disease duration of at least two years from onset of disease. Progression of more than 1 point on the EDSS scale during the last 2 years. EDSS (Expanded Disability Status Score) of more than or equal to 4 and less than or equal to 6.5. MRI scan of the brain that fulfills the Barkhof criteria for MS. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy or period of breastfeeding; missing adequate contraceptive protection for female patients with childbearing potential. Acceptable methods of birth control in this study include: sexually inactive, surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, longacting injectable contraceptive or a double-barrier method (condom or diaphragm with spermicide). Treatment with steroids in the last 30 days Previous treatment with EPO Treatment with interferons, glatiramer acetate or IVIG in the 3 months prior to enrolment Treatment with azathioprin, mitoxantrone or any other immuno-suppressive in the 6 months prior to enrolment Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension (systolic > 180, diastolic > 110) History of any haematological disorder History of renal insufficiency Any medical psychiatric or other circumstances which impede or restrict the subjects participation in the study in the manner intended Contraindication for MRI (e.g. pace maker, aortic clip or any metal implant)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to evaluate the effect on the clinical outcome measures of treatment with NeoRecomorn compared with placebo in patients with progressive Multiple Sclerosis. The primary outcome measure is a composite of maximum gait distance, 9-hole peg test, TRAIL making B. ;Secondary Objective: Secondary outcome measures include maximum gait distance, 9-hole peg test, TRAIL making B, MS Functional Composite, Expanded Disability Status Score, MR skanning measures of the brain, and safety measures.;Primary end point(s): The primary end point is the change from baseline to 24 weeks in a composite score of maximum gait distance, 9-hole peg test and TRAIL making B test, comparing the placebo treated group with the NeoRecomorn group. | — |
Countries
Denmark
Outcome results
None listed