Corticoterapia Oral en Megadosis para el Tratamiento del Brote de Esclerosis Múltiple
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Methylprednisolone
Glucocorticoid receptor agonist
Compared with
- Methylprednisolone
Glucocorticoid receptor agonist
Placebo or sham
- Placebo
What it measured
Main measures
Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis
day 28
RelapsesChange in EDSS in patients who present a relapse from different type or unknown topography
day 28
Disability progressionRelapsesLa variable principal de medida será el cambio habido, en cada grupo de tratamiento, entre los días 28 y 0:
Other measures (2)
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
Who could take part
MS (type not specified) · 18 to 59
Inclusion Criteria: 1. To have been diagnosed MS Remittent Recurrent according to Mc Donald 20052 criteria. 2. To have an EDSS between 0 and 5 before the relapse. 3. The symptoms have begun after at least one month of previous stability. 4. The symptoms have started maximum 15 days before the inclusion. 5. The patient is capable of having an adequate communication with the investigator and to carry out with the clinical trial requisites. 6. To be or not to be with allowed immunomodulatory therapy (IFN-B /AG). 7. To be capable and to be willing to ingest the medication. Exclusion Criteria: 1. First inflammatory neurological episode (relapse). 2. Multiple sclerosis secondary progressive or primary progressive. 3. The symptoms have gone on for less than 24 hours. 4. To be in treatment or have been treated with corticoids during the three months before. 5. Patients in treatment with immunosuppressors (azathioprine, mitoxantrone, ciclofosfamide...) 6. Pregnancy or breastfeeding or women in fertile age who don't use contraceptives measurements. 7. Illnesses with contraindication treatment with corticoids. 8. Antecedents of serious adverse effects or hypersensitive to related study medication. 9. Patients who wouldn´t be able to perform periodic RMN explorations, patients who are not collaborative or who need anesthesia. 10. Patients with intolerance to lactose. 11. Patients with allergy to contrast used in RMN. 12. Patients with chronic kidney disease. 13. Patients in treatment with natalizumab.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Similar biological effect of high-dose oral versus intravenous methylprednisolone in multiple sclerosis relapses.Mult Scler · 2015
Results
A randomized clinical trial of oral versus intravenous methylprednisolone for relapse of MS.Mult Scler · 2014
Results
Ramo-Tello C, Tintore M, Rovira A, Ramio-Torrenta L, Brieva L, Saiz A, Cano A, Carmona O, Hervas JV, Grau-Lopez L. Baseline clinical status as a predictor of methylprednisolone response in multiple sclerosis relapses. Mult Scler. 2016 Jan;22(1):117-21. doi: 10.1177/1352458515590648. Epub 2015 Jun 25.
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History
Started
Nov 2008
Main results due
Nov 2010
Finished
Jan 2011
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