Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse

Sponsor

Germans Trias i Pujol Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00753792

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: methylprednisolone Drug: methylprednisolone Drug: Placebo	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 methylprednisolone 1.000 mg/day intravenous administration during three days + placebo of methylprednisolone orally administered	Drug: methylprednisolone methylprednisolone 1.000 mg/day intravenous administration during three days Other Names: Group A Drug: Placebo Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1) Other Names: Group A Group B
Experimental: 2 methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenous administered	Drug: methylprednisolone methylprednisolone 1.250 mg/day orally administered during three days Other Names: Group B Drug: Placebo Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1) Other Names: Group A Group B

Arm

Intervention/Treatment

Active Comparator: 1

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

Drug: methylprednisolone

methylprednisolone 1.000 mg/day intravenous administration during three days

Other Names:

Group A

Drug: Placebo

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

Other Names:

Group A

Group B

Experimental: 2

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

Drug: methylprednisolone

methylprednisolone 1.250 mg/day orally administered during three days

Other Names:

Group B

Drug: Placebo

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

Other Names:

Group A

Group B

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Germans Trias i Pujol Hospital	Badalona	Barcelona	Spain	08916
2	Hospital de Figueres	Figueres	Girona	Spain	17600
3	Hospital de Mataró	Barcelona		Spain	08034
4	Hospital Vall d'Hebron	Barcelona		Spain	08035
5	Hospital Clinic de Barcelona	Barcelona		Spain	08036
6	Hospital Dr. Trueta	Girona		Spain	17007
7	Hospital Arnau de Vilanova	Lleida		Spain	25198