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

NCT01411514 | Terminated Phase 4

• 1 other identifier: EOC.NC.10.04
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Multiple Sclerosis

Keywords

Relapsing remittent multipse sclerosis; Secondary progressive multiple sclerosis; Clinically isolated syndrome; Primary progressive multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 3 months

Secondary Outcomes (28)

• Expanded Disability Status Scale (EDSS)

  baseline, 25 days (end of treatment)

• Multiple Sclerosis Functional Composite Score (MSFC)

  baseline, 25 days (end of treatment)

• Gd-enhancing lesions on T1-weighted images

  baseline, 25 days (end of treatment)

• number of new T2-hyperintense lesions

  baseline, 25 days (end of treatment)

• mental status (MUSIC)

  baseline, 25 days (end of treatment)

Study Arms (2)

Prednisone

EXPERIMENTAL

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Prednisone DRUG

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

Also known as: Prednison Axapharm

Prednisone

Placebo DRUG

Placebo tablets. They will be administered during 25 days

Also known as: Placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Claudio Gobbi: lead
• Ente Ospedaliero Cantonale, Ticino, Switzerland: collaborator

Study Sites (1)

Osepdale Civico

Lugano, Canton Ticino, 6903, Switzerland

Location

Related Publications (4)

• Sellebjerg F, Barnes D, Filippini G, Midgard R, Montalban X, Rieckmann P, Selmaj K, Visser LH, Sorensen PS; EFNS Task Force on Treatment of Multiple Sclerosis Relapses. EFNS guideline on treatment of multiple sclerosis relapses: report of an EFNS task force on treatment of multiple sclerosis relapses. Eur J Neurol. 2005 Dec;12(12):939-46. doi: 10.1111/j.1468-1331.2005.01352.x.

  PMID: 16324087 BACKGROUND

• Burton JM, O'Connor PW, Hohol M, Beyene J. Oral versus intravenous steroids for treatment of relapses in multiple sclerosis. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006921. doi: 10.1002/14651858.CD006921.pub2.

  PMID: 19588409 BACKGROUND

• Martinelli V, Rocca MA, Annovazzi P, Pulizzi A, Rodegher M, Martinelli Boneschi F, Scotti R, Falini A, Sormani MP, Comi G, Filippi M. A short-term randomized MRI study of high-dose oral vs intravenous methylprednisolone in MS. Neurology. 2009 Dec 1;73(22):1842-8. doi: 10.1212/WNL.0b013e3181c3fd5b.

  PMID: 19949030 BACKGROUND

• Perumal JS, Caon C, Hreha S, Zabad R, Tselis A, Lisak R, Khan O. Oral prednisone taper following intravenous steroids fails to improve disability or recovery from relapses in multiple sclerosis. Eur J Neurol. 2008 Jul;15(7):677-80. doi: 10.1111/j.1468-1331.2008.02146.x. Epub 2008 May 6.

  PMID: 18459972 BACKGROUND

Related Links

• Related information to the institution
• Non profit organisazion that supports multiple sclerosis patients

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Claudio Gobbi, MD

  Neurocenter of Southern Switzerland

  PRINCIPAL INVESTIGATOR

• Claudio Gobbi, MD

  Neurocenter of Southern Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: August 8, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

CH (1)