Phase IV Study of Oral Prednisone Taper vs. Placebo Following Intravenous Steroids for the Treatment of Acute Relapses in Multiple Sclerosis Within the Ticino Cohort

Fecha de inicio: 1 de agosto de 2011

Inclusion Criteria: * female or male * aged between 18 and 80 years; * with relapsing forms of multiple sclerosis diagnosed according to McDonald's criteria, including RR-MS and relapsing SP-MS, CIS, PP; * with EDSS score between 0 and 8; * experiencing an acute relapse with a documented clinical worsening of at least one point of the EDSS scale or a worsening of at least 2 points in one of the EDSS functional systems; * having agreed to have MRI and having already received at least one enhanced MRI before study procedures without major side effects; * having agreed to adhere to the study procedures; * having signed the written informed consent form. Exclusion Criteria: * secondary progressive MS without superimposing relapses; * primary progressive MS without superimposed relapses; * patients suffering from any clinical condition contraindicated for steroid, in particular * Systemic fungal infection * Severe osteoporosis * Uncontrolled hypertension or congestive heart failure. * Existing or previous history of severe affective disorders (especially previous steroid psychosis). * Diabetes mellitus * History of tuberculosis * Glaucoma * Previous corticosteroid-induced myopathy * Liver failure or cirrhosis * Renal insufficiency * Active epilepsy * Peptic ulceration * Fresh intestinal anastomoses * Predisposition to thrombophlebitis * Abscess or other pyogenic infections * Diverticulitis * Myasthenia gravis * Ocular herpes simplex * Hypothyroidism * Recent myocardial infarction * Kaposi's sarcoma; * any disease other than multiple sclerosis that would better explain the patient's signs and symptoms; * women of potential childbearing without active contraceptive methods; * pregnancy (urine pregnancy test at baseline visit) or breast feeding; * history of affective disorders; * history of attempted suicide or current suicidal ideas; * medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study; * inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study; * known hypersensitivity to prednisone or excipients of the study medications; * any contraindication for concomitant medications; * any contraindication for MRI or contrast administration; * a history of drug abuse in the 6 months prior to screening; * use of steroids during the previous 30 days (disease-modifying therapies for the treatment of MS are allowed); * treatment with drugs that might interfere with the evaluation of study drugs during the study protocol (see Section 4.2.2); * likelihood of requiring treatment during the study period with drugs not permitted by the study protocol; * participation in an other clinical trial within 30 days prior to entry in this study or current participation in another trial.