Back to results

Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

methylprednisolone

Placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, relapse, methylprednisolone

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Germans Trias i Pujol Hospital
Hospital de Figueres
Hospital de Mataró
Hospital Vall d'Hebron
Hospital Clinic de Barcelona
Hospital Dr. Trueta
Hospital Arnau de Vilanova

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis

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

Secondary Outcome Measures

Change in the punctuation in each group

Percentage of patients who improve, get worse and keep stable

Full Information

NCT ID

NCT00753792

First Posted

September 16, 2008

Last Updated

June 1, 2011

Sponsor

Germans Trias i Pujol Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00753792

Brief Title

Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse

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 Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Germans Trias i Pujol Hospital

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

multiple sclerosis, relapse, methylprednisolone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

methylprednisolone

Other Intervention Name(s)

Group A

Intervention Description

methylprednisolone 1.000 mg/day intravenous administration during three days

Intervention Type

Drug

Intervention Name(s)

methylprednisolone

Other Intervention Name(s)

Group B

Intervention Description

methylprednisolone 1.250 mg/day orally administered during three days

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Group A, Group B

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis

Time Frame

day 28

Title

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

Time Frame

day 28

Secondary Outcome Measure Information:

Title

Change in the punctuation in each group

Time Frame

between days 7 and 0

Title

Percentage of patients who improve, get worse and keep stable

Time Frame

days 7 and 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cristina Ramo, MD

Organizational Affiliation

Germans Trias i Pujol Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Germans Trias i Pujol Hospital

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital de Figueres

City

Figueres

State/Province

Girona

ZIP/Postal Code

17600

Country

Spain

Facility Name

Hospital de Mataró

City

Barcelona

ZIP/Postal Code

08034

Country

Spain

Facility Name

Hospital Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Clinic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Dr. Trueta

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Hospital Arnau de Vilanova

City

Lleida

ZIP/Postal Code

25198

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

26540732

Citation

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.

Results Reference

derived

PubMed Identifier

25145693

Citation

Grau-Lopez L, Teniente-Serra A, Tintore M, Rovira A, Ramio-Torrenta L, Brieva L, Saiz A, Cano A, Carmona O, Hervas JV, Martinez-Caceres EM, Ramo-Tello C. Similar biological effect of high-dose oral versus intravenous methylprednisolone in multiple sclerosis relapses. Mult Scler. 2015 Apr;21(5):646-50. doi: 10.1177/1352458514546786. Epub 2014 Aug 21.

Results Reference

derived

PubMed Identifier

24144876

Citation

Ramo-Tello C, Grau-Lopez L, Tintore M, Rovira A, Ramio i Torrenta L, Brieva L, Cano A, Carmona O, Saiz A, Torres F, Giner P, Nos C, Massuet A, Montalban X, Martinez-Caceres E, Costa J. A randomized clinical trial of oral versus intravenous methylprednisolone for relapse of MS. Mult Scler. 2014 May;20(6):717-25. doi: 10.1177/1352458513508835. Epub 2013 Oct 21.

Results Reference

derived

Learn more about this trial

Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse

We'll reach out to this number within 24 hrs