Status:
TERMINATED
Oral Prednisone Taper Versus Placebo for the Treatment of Acute Relapses in Multiple Sclerosis
Lead Sponsor:
Claudio Gobbi
Collaborating Sponsors:
Ente Ospedaliero Cantonale, Ticino, Switzerland
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 ...
Detailed Description
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 durin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01411514
Start Date
August 1 2011
End Date
January 1 2015
Last Update
December 18 2015
Active Locations (1)
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1
Osepdale Civico
Lugano, Canton Ticino, Switzerland, 6903