Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse

Study Overview
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Brief Summary
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This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate or severe attack receiving immunomodulatory therapy or not. Patients will be randomly assigned to one of the two groups.

Detailed Description
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This is a multicenter, randomized, double blind clinical trial to test whether oral methylprednisolone (MP) is not inferior to intravenous methylprednisolone for the treatment of multiple sclerosis (MS) relapse in terms of clinical and radiological efficacy. Patients will be randomly assigned to one of the following two groups. Group A: methylprednisolone 1.000 mg/day intravenous administered during three days + placebo of methylprednisolone orally administered Group B: methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenously administered. Clinical visits will be conducted at 7, 28 and 90 days after treatment starting.

Official Title
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Multicenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: methylprednisolone
* Drug: methylprednisolone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To have been diagnosed MS Remittent Recurrent according to Mc Donald 20052 criteria. To have an EDSS between 0 and 5 before the relapse. The symptoms have begun after at least one month of previous stability. The symptoms have started maximum 15 days before the inclusion. The patient is capable of having an adequate communication with the investigator and to carry out with the clinical trial requisites. To be or not to be with allowed immunomodulatory therapy (IFN-B /AG). To be capable and to be willing to ingest the medication. Exclusion Criteria: First inflammatory neurological episode (relapse). Multiple sclerosis secondary progressive or primary progressive. The symptoms have gone on for less than 24 hours. To be in treatment or have been treated with corticoids during the three months before. Patients in treatment with immunosuppressors (azathioprine, mitoxantrone, ciclofosfamide...) Pregnancy or breastfeeding or women in fertile age who don't use contraceptives measurements. Illnesses with contraindication treatment with corticoids. Antecedents of serious adverse effects or hypersensitive to related study medication. Patients who wouldn´t be able to perform periodic RMN explorations, patients who are not collaborative or who need anesthesia. Patients with intolerance to lactose. Patients with allergy to contrast used in RMN. Patients with chronic kidney disease. Patients in treatment with natalizumab.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>methylprednisolone 1.000 mg/day intravenous administration during three days + placebo of methylprednisolone orally administered | Drug: methylprednisolone<br>* methylprednisolone 1.000 mg/day intravenous administration during three days<br>* Other names: Group A;Drug: Placebo<br>* Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)<br>* Other names: Group B;|
| Experimental: 2<br>methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenous administered | Drug: methylprednisolone<br>* methylprednisolone 1.250 mg/day orally administered during three days<br>* Other names: Group B;Drug: Placebo<br>* Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)<br>* Other names: Group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis |  | day 28 | 
| Change in EDSS in patients who present a relapse from different type or unknown topography |  | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the punctuation in each group |  | between days 7 and 0 | 
| Percentage of patients who improve, get worse and keep stable |  | days 7 and 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, relapse, methylprednisolone