Oral Prednisone Taper Versus Placebo for the Treatment of Acute Relapses in Multiple Sclerosis
NCT ID: NCT01411514
Last Updated: 2015-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
27 participants
INTERVENTIONAL
2011-08-31
2015-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prednisone
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
Placebo
Placebo
Placebo tablets. They will be administered during 25 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Placebo
Placebo tablets. They will be administered during 25 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ente Ospedaliero Cantonale, Ticino, Switzerland
OTHER
Claudio Gobbi
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Claudio Gobbi
Dr. med.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claudio Gobbi, MD
Role: PRINCIPAL_INVESTIGATOR
Neurocenter of Southern Switzerland
Claudio Gobbi, MD
Role: STUDY_DIRECTOR
Neurocenter of Southern Switzerland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Osepdale Civico
Lugano, Canton Ticino, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related information to the institution
Non profit organisazion that supports multiple sclerosis patients
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EOC.NC.10.04
Identifier Type: -
Identifier Source: org_study_id