Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-01-31

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.

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

methylprednisolone 1.000 mg/day intravenous administration during three days + placebo of methylprednisolone orally administered

Group Type ACTIVE_COMPARATOR

methylprednisolone

Intervention Type DRUG

methylprednisolone 1.000 mg/day intravenous administration during three days

Placebo

Intervention Type DRUG

Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)

2

methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenous administered

Group Type EXPERIMENTAL

methylprednisolone

Intervention Type DRUG

methylprednisolone 1.250 mg/day orally administered during three days

Placebo

Intervention Type DRUG

Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)

Interventions

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methylprednisolone

methylprednisolone 1.000 mg/day intravenous administration during three days

Intervention Type DRUG

methylprednisolone

methylprednisolone 1.250 mg/day orally administered during three days

Intervention Type DRUG

Placebo

Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)

Intervention Type DRUG

Other Intervention Names

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Group A Group B Group A Group B

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No