Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether cyclic oral methylprednisolone once every month has an effect on the intrathecal inflammation in patients suffering from progressive multiple sclerosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Age between 18 and 65 years old

• Progressive form of MS (Eg. primary or secondary progressive MS)

• Duration of progressive phase at least 1 year

• Progression of at least 1 EDSS point for the last 2 years or at least ½ EDSS point in patients with EDSS > 5,5

• Progressin in 2 FS point

• EDSS
• Signed informed consent and written authority

Exclusion Criteria:

• Pregnancy and breast feeding

• Lack of secure contraception for women of child-bearing age (hormonal or intrauterine device)

• Attack in the last month previous to inclusion

• Treatment with methylprednisolone or cyclic methylprednisolone the 3 previous month before inclusion

• Treatment with interferon-beta, Glatiramer acetate, immunglobulin G or other immunomodulating treatment the 3 previous month before inclusion

• Treatment with Mitoxantrone, ciclofosfamide, Azathioprin or other immunosuppressive treatment the 6 previous month before inclusion

• Previous treatment with drugs which the treating physician finds could have influence on the study results

• Diseases associated with immune defects

• Treatment with other anticoagulant than acetyl salicyl acid

• Malignancy

• Diabetes Mellitus

• Renal insufficiency or S-Creatinine > 150 mmol/l

• Acute or chronic infections with hepatitis B og C virus, HIV or other infections which the treating physician finds relevant

• Psychiatric illness or other conditions which can impair the collaboration of the patient participating in the study

• Contra-indication to MRI

• Hypersensitivity to methylprednisolone

• Osteoporosis