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Oral Prednisone Taper Versus Placebo for the Treatment of Acute Relapses in Multiple Sclerosis

NCT01411514 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-12-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Prednisone

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

DRUG

Placebo

Placebo tablets. They will be administered during 25 days

Sponsors & Collaborators

  • Ente Ospedaliero Cantonale, Ticino, Switzerland

    collaborator OTHER

  • Claudio Gobbi

    lead OTHER_GOV

Principal Investigators

  • Claudio Gobbi, MD · Neurocenter of Southern Switzerland

  • Claudio Gobbi, MD · Neurocenter of Southern Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01411514 on ClinicalTrials.gov