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
Prednisone
+ Placebo
Autoimmune Diseases+9
+ Chronic Disease
+ Demyelinating Diseases
Treatment Study
Summary
Study start date: August 1, 2011
Actual date on which the first participant was enrolled.The purpose of this double-blind, randomised, placebo-controlled, prospective, parallel group, single centre study is to evaluate the effect of tapering oral doses of prednisone or placebo taken during 25 days following short-term high-dose i.v. methylprednisolone on the outcome of a relapse in patients with CIS; RR-MS, PP-MS or SP-MS with superimposed relapses. The primary objective is to assess and compare the recovery status in both patient groups 3 months after baseline by means of Expanded Disability Status Scale (EDSS). Secondary objectives are the assessments of clinical parameters at the end of oral treatment, 6, 9 months after baseline, of MRI markers, of mental and cognitive status, quality of life and fatigue at the end of oral treatment, 3 and 6 months after baseline in both patient groups. After standard treatment of an acute clinical relapse with high dose, short term i.v. methyprednisolone patients will be randomised to one of the two treatment arms. Patients allocated to prednisone will be treated with tapering oral doses during 25 days. The initial dose of 60 mg will be reduced twice by 20 mg, than by 10 and 5 mg. Each dose regimen will be taken during 5±2 days. Patients randomised to placebo will receive placebo treatment during 25 days.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.27 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location