CompletedPhase 4MS (type not specified)NCT007537922007-000888-15

What it found

Result in a paper, not read yet

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

    Relapses
  • Change in EDSS in patients who present a relapse from different type or unknown topography

    day 28

    Disability progressionRelapses
  • La 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

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Related trials

History

    1. Started

      Nov 2008

    2. Main results due

      Nov 2010

    3. Finished

      Jan 2011

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