Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse - Full Text View

Sponsored by:	Germans Trias i Pujol Hospital
Information provided by:	Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:	NCT00753792

Purpose

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	Intervention	Phase
Multiple Sclerosis	Drug: methylprednisolone Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Methylprednisolone

U.S. FDA Resources

Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Change in EDSS in patients who present a relapse from different type or unknown topography [ Time Frame: day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in the punctuation in each group [ Time Frame: between days 7 and 0 ] [ Designated as safety issue: No ]
Percentage of patients who improve, get worse and keep stable [ Time Frame: days 7 and 28 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	November 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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 Drug: Placebo Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)
2: Experimental 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 Drug: Placebo Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)

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.

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753792

Contacts

Contact: Cristina Ramo, MD

93 497 88 62

cramot.germanstrias@gencat.cat

Locations

Spain
Hospital Vall d'Hebron	Recruiting
Barcelona, Spain, 08035
Contact: Yolanda Pérez, MD 934286034 yoperez@vhebron.net
Principal Investigator: Mar Tintoré, MD
Sub-Investigator: Yolanda Pérez, MD
Sub-Investigator: Àlex Rovira, MD
Sub-Investigator: Marta Sallen, MD
Sub-Investigator: Carlos Nos, MD
Sub-Investigator: Xavier Aymerich, MD
Sub-Investigator: Mª Carmen Edo, MD
Hospital Clinic de Barcelona	Recruiting
Barcelona, Spain, 08036
Contact: Teresa Pujol, MD 932275412 tpujol@clinic.ub.es
Sub-Investigator: Yolanda Blanco, MD
Sub-Investigator: Teresa Pujol, MD
Hospital de Mataró	Recruiting
Barcelona, Spain, 08034
Contact: Antonio Cano, MD
Sub-Investigator: Jordi Bartrina, MD
Hospital Dr. Trueta	Recruiting
Girona, Spain, 17007
Contact: Lluís Ramió, MD
Sub-Investigator: Gemma Laguillo, MD
Sub-Investigator: Salvador Pedraza, MD
Hospital Arnau de Vilanova	Recruiting
Lleida, Spain, 25198
Contact: Luís Brieva, MD
Sub-Investigator: Mabel Gil, MD
Spain, Barcelona
Germans Trias i Pujol Hospital	Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Cristina Ramo, MD 93 497 88 62 cramot.germanstrias@gencat.cat
Principal Investigator: Cristina Ramo, MD
Sub-Investigator: Joan Costa, MD
Sub-Investigator: Pilar Giner, MD
Sub-Investigator: : Laia Grau, MD
Sub-Investigator: Eva Montané, MD
Sub-Investigator: Jaume Capellades, MD
Spain, Girona
Hospital de Figueres	Recruiting
Figueres, Girona, Spain, 17600
Contact: Olga Carmona, MD
Sub-Investigator: Raúl Martínez, MD
Sub-Investigator: Joan Carles Vilanova, MD
Sub-Investigator: Joaquim Barceló, MD

Sponsors and Collaborators

Germans Trias i Pujol Hospital

Investigators

Principal Investigator:

Cristina Ramo, MD

Germans Trias i Pujol Hospital

More Information

No publications provided

Responsible Party:	Germans Trias i Pujol University Hospital ( Cristina Ramo. MD )
Study ID Numbers:	CORTEM, 2007-000888-15
Study First Received:	September 16, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00753792 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:

multiple sclerosis
relapse
methylprednisolone

Study placed in the following topic categories:

Anti-Inflammatory Agents
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Demyelinating Diseases
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Methylprednisolone acetate
Sclerosis
Prednisolone acetate

Hormones
Glucocorticoids
Neuroprotective Agents
Recurrence
Multiple Sclerosis
Prednisolone
Demyelinating Autoimmune Diseases, CNS
Peripheral Nervous System Agents
Autoimmune Diseases of the Nervous System
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Disease Attributes
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Pathologic Processes
Multiple Sclerosis
Therapeutic Uses
Autoimmune Diseases of the Nervous System
Methylprednisolone Hemisuccinate

Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Sclerosis
Glucocorticoids
Protective Agents
Recurrence
Pharmacologic Actions
Autonomic Agents
Prednisolone
Demyelinating Autoimmune Diseases, CNS

ClinicalTrials.gov processed this record on September 02, 2009