NCT00753792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_4 multiple-sclerosis

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 2, 2011

Status Verified

June 1, 2011

Enrollment Period

2 years

First QC Date

September 16, 2008

Last Update Submit

June 1, 2011

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisrelapsemethylprednisolone

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: methylprednisoloneDrug: Placebo

2

EXPERIMENTAL

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

Drug: methylprednisoloneDrug: Placebo

Interventions

methylprednisoloneDRUG

methylprednisolone 1.000 mg/day intravenous administration during three days

Also known as: Group A
1
PlaceboDRUG

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

Also known as: Group A, Group B
12

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital de Mataró

Barcelona, Barcelona, 08034, Spain

Location

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital de Figueres

Figueres, Girona, 17600, Spain

Location

Hospital Dr. Trueta

Girona, Girona, 17007, Spain

Location

Hospital Arnau de Vilanova

Lleida, Lleida, 25198, Spain

Location

Related Publications (3)

  • 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.

    PMID: 26540732DERIVED

  • 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.

    PMID: 25145693DERIVED

  • 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.

    PMID: 24144876DERIVED

MeSH Terms

Conditions

Multiple SclerosisRecurrence

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Cristina Ramo, MD

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 17, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2010

Study Completion

January 1, 2011

Last Updated

June 2, 2011

Record last verified: 2011-06

Locations

ES(7)