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Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse

This study has been completed.
Sponsor:
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT00753792
First received: September 16, 2008
Last updated: June 1, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Multiple Sclerosis
 Drug: methylprednisolone
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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 ]

Enrollment: 49
Study Start Date: November 2008
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Group B
Drug: Placebo
Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)
Other Names:
  • Group A
  • Group B

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:

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

Locations
Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Hospital de Figueres
Figueres, Girona, Spain, 17600
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital de Mataró
Barcelona, Spain, 08034
Hospital Dr. Trueta
Girona, Spain, 17007
Hospital Arnau de Vilanova
Lleida, Spain, 25198
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: Cristina Ramo. MD, Germans Trias i Pujol University Hospital
ClinicalTrials.gov Identifier: NCT00753792     History of Changes
Other Study ID Numbers: CORTEM, 2007-000888-15
Study First Received: September 16, 2008
Last Updated: June 1, 2011
Health Authority: Spain: Ministry of Health

Keywords provided by Germans Trias i Pujol Hospital:
multiple sclerosis
relapse
methylprednisolone

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
 Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013