The management of MS-patients requires treatment with immune-modifying or immune-suppressive agents to prevent new relapses and progression of disability. Several studies have evaluated the effect of steroid treatment on clinical recovery after an acute relapse. An important unanswered clinical question is, whether or not an oral tapering dose of corticosteroids offers any additional advantage over intravenous methylprednisolone alone in improving neurologic recovery as well as safety and tolerability after a relapse. This study aims to compare the efficacy, tolerability and safety of tapering doses of oral prednisone and placebo after short-term high-dose i.v. methylprednisolone on the recovery from an acute relapse in patients with clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RR-MS) and primary (PP-MS) or secondary progressive multiple sclerosis (SP-MS) with superimposed relapses. Patients will be treated during 25 days with de-escaling doses of prednisone or placebo. The primary analysis will test whether placebo is equivalent to oral prednisone taper on the recovery status as measured by EDSS change from baseline to 3 months after baseline.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
Tablets, 60 mg od p.o. for 5 days, followed by 40 mg o.d. p.o. for 5 days, 20 mg o.d. p.o. for 5 days, 10 mg o.d. p.o. for 5 days, 5 mg o.d. p.o. for 5 days
Placebo tablets. They will be administered during 25 days
Osepdale Civico
Lugano, Canton Ticino, Switzerland
Expanded Disability Status Scale (EDSS)
The scores of the Expanded Disability Status Scale (EDSS) will be assessed at baseline, defined as start of oral treatment with prednisone or placebo (Day 1), and 3 months after baseline.
Time frame: baseline, 3 months
Expanded Disability Status Scale (EDSS)
the scores of the Expanded Disability Status Scale (EDSS) will be assessed at baseline, at end of treatment, 6, and 9 months after baseline;
Time frame: baseline, 25 days (end of treatment)
Multiple Sclerosis Functional Composite Score (MSFC)
the Multiple Sclerosis Functional Composite Score (MSFC) includes the Timed 25 foot-walk-test, the 9 Hole Peg test and Paced Auditorial Addition Test (PASAT)
Time frame: baseline, 25 days (end of treatment)
Gd-enhancing lesions on T1-weighted images
the evolution of the number of Gd-enhancing lesions on T1-weighted images will be assessed
Time frame: baseline, 25 days (end of treatment)
number of new T2-hyperintense lesions
the evolution of the number of new T2-hyperintense lesions will be assessed
Time frame: baseline, 25 days (end of treatment)
mental status (MUSIC)
investigator administered questionnaire
Time frame: baseline, 25 days (end of treatment)
Euroqol-5D (EQ-5D
patient reported quality of life
Time frame: baseline, 25 days (end of treatment)
Functional Assessment Multiple Sclerosis (FAMS)
Patient reported outcome
Time frame: at baseline, 25 days (end of treatment)
Beck Depression Inventory Second edition (BDI-II)
Investigator administered questionnaire
Time frame: baseline, 25 days (end of treatment)
Fatigue Scale for Motor and Cognitive functions (FSMC)
Investigator administered questionnaire
Time frame: baseline, 25 days (end of treatment)
Expanded Disability Status Scale (EDSS)
The scores of the Expanded Disability Status Scale (EDSS) will be assessed at baseline, defined as start of oral treatment with prednisone or placebo (Day 1), and 6 months after baseline.
Time frame: baseline, 6 months
Expanded Disability Status Scale (EDSS)
The scores of the Expanded Disability Status Scale (EDSS) will be assessed at baseline, defined as start of oral treatment with prednisone or placebo (Day 1), and 9 months after baseline.
Time frame: baseline, 9 months
Multiple Sclerosis Functional Composite Score (MSFC)
the Multiple Sclerosis Functional Composite Score (MSFC) includes the Timed 25 foot-walk-test, the 9 Hole Peg test and Paced Auditorial Addition Test (PASAT)
Time frame: baseline, 3 months
Multiple Sclerosis Functional Composite Score (MSFC)
the Multiple Sclerosis Functional Composite Score (MSFC) includes the Timed 25 foot-walk-test, the 9 Hole Peg test and Paced Auditorial Addition Test (PASAT)
Time frame: baseline, 6 months
Multiple Sclerosis Functional Composite Score (MSFC)
the Multiple Sclerosis Functional Composite Score (MSFC) includes the Timed 25 foot-walk-test, the 9 Hole Peg test and Paced Auditorial Addition Test (PASAT)
Time frame: baseline, 9 months
Gd-enhancing lesions on T1-weighted images
the evolution of the number of Gd-enhancing lesions on T1-weighted images will be assessed
Time frame: baseline, 3 months
Gd-enhancing lesions on T1-weighted images
the evolution of the number of Gd-enhancing lesions on T1-weighted images will be assessed
Time frame: baseline, 6 months
number of new T2-hyperintense lesions
the evolution of the number of new T2-hyperintense lesions will be assessed
Time frame: baseline, 3 months
number of new T2-hyperintense lesions
the evolution of the number of new T2-hyperintense lesions will be assessed
Time frame: baseline, 6 months
mental status (MUSIC)
investigator administered questionnaire
Time frame: baseline, 3 months
mental status (MUSIC)
investigator administered questionnaire
Time frame: baseline, 6 months
Euroqol-5D (EQ-5D
patient reported quality of life
Time frame: baseline, 3 months
Euroqol-5D (EQ-5D
patient reported quality of life
Time frame: baseline, 6 months
Functional Assessment Multiple Sclerosis (FAMS)
Patient reported outcome
Time frame: at baseline, 3 months
Functional Assessment Multiple Sclerosis (FAMS)
Patient reported outcome
Time frame: at baseline, 6 months
Beck Depression Inventory Second edition (BDI-II)
Investigator administered questionnaire
Time frame: baseline, 3 months
Beck Depression Inventory Second edition (BDI-II)
Investigator administered questionnaire
Time frame: baseline, 6 months
Fatigue Scale for Motor and Cognitive functions (FSMC)
Investigator administered questionnaire
Time frame: baseline, 3 months
Fatigue Scale for Motor and Cognitive functions (FSMC)
Investigator administered questionnaire
Time frame: baseline, 6 months
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