Oral Prednisone Taper Versus Placebo for the Treatment of Acute Relapses in Multiple Sclerosis
Status:
Terminated
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
Summary
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.