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Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986998
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Cristina Ramo, Germans Trias i Pujol Hospital

Study Description
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Brief Summary:
The investigators plan to carry out a multicenter randomized clinical trial and MRI study of high-dose oMP (1250mg/day for 3 days) versus lower-high dose oMP (625mg/day for 3 days) and demonstrated that lower-high dose of oMP is as effective as a higher-high dose of oMP in acute relapse of multiple sclerosis (MS). If it is shown, our purpose is to promote this therapeutic regimen because it is safer for the patient (less adverse effects) and less costly to the healthcare system.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Methylprednisolone 1250 mg/24h x3 days Drug: Oral Methylprednisolone 625 mg/24h x3 days Phase 4

Detailed Description:

DESIGN: Phase IV clinical trial, multicentre, randomized and double blind, active drug controlled and parallel groups. Patients will be randomised to a high dose of oMP vs a lower-high dose of oral Methylprednisolone (oMP).

SETTING: 9 MS Units from 9 hospitals of the public health system with extensive experience in treating patients with MS and design and participation in clinical trials.

PROCEDURES:

After signing the informed consent, the inclusion and exclusion criteria specific to the study will be checked. The diagnostic test will take place prior to administration of study medication and will include medical history, neurological examination (EDSS measurement) taking of vital signs (blood pressure, heart rate and body temperature) and MRI. Concomitant medication will be checked. Patients will be instructed about the requirements during the study.

The trial medication will be provided to the patient in the medical office (day 1 of the study), where the patient will remain until the intake. This action will be repeated the following 2 days. The latency period from the beginning of the relapse until the start of treatment will be registered. The questionnaires of tolerance will be completed.

Day 1 will be defined as the first day on which first dose of oMP is administered.

Once given the treatment under study, the adverse events reported spontaneously or after question will be collected.

There will be follow-up visits at 7 and 28 days, and 3 months after initiation of treatment. At baseline, prior to drug administration, and on days 7 and 28 after initiation of treatment, a brain MRI with and without contrast will be performed. In case of adverse events or laboratory abnormalities, the patients could have an accessory follow-up visits until resolution.

Randomization will be performed on the day of administration (day 1)

The treatments are:

Group A: Methylprednisolone 1250 mg / day orally for 3 days Group B: Methylprednisolone 625 mg / day orally for 3 days

Study Design
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Study Type : Interventional  (Clinical Trial)
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 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse.
Study Start Date : October 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: oMP 1250 mg: Group A
Methylprednisolone 1250 mg/24h x3 days
 Drug: Methylprednisolone 1250 mg/24h x3 days
Oral Methylprednisolone 1.250 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (12 capsules of 100 mg and 1 capsule of 50 mg)
Other Name: Group A
Active Comparator: oMP 625 mg: Group B
Methylprednisolone oral 625 mg/24h x3 days
 Drug: Oral Methylprednisolone 625 mg/24h x3 days
Oral Methylprednisolone 625 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (6 capsules of 100 mg, 1 capsule of 25 mg and 6 capsules of placebo with the same appearance of capsules of 100 mg)
Other Name: Group B


Outcome Measures
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Primary Outcome Measures :
  1. Disability scale of Kurtzke EDSS score [ Time Frame: up to day 91 ]

Secondary Outcome Measures :
  1. Adverse events / tolerability [ Time Frame: Baseline and day 29 ]
  2. Disability scale of Kurtzke EDSS score [ Time Frame: Baseline and day 8 ]
  3. The number and volume of active lesions (measured by the T2 or gadolinium enhancement), the number of new active lesions and the percentage of active lesions at baseline that becomes black holes [ Time Frame: day -1 and day 29 ]
  4. Adverse events / tolerability [ Time Frame: Baseline and day 8 ]
  5. Questionnaire MSQOL-54 [ Time Frame: Baseline and day 8 ]
  6. Questionnaire MSQOL-54 [ Time Frame: Baseline and day 29 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Relapsing-remitting MS (Mc Donald criteria 2010) regardless being under immunomodulatory treatment
  2. EDSS (previous to relapse) between 0 and 5

  3. MS relapse of moderate intensity (EDSS increase from 1 to 2.5 points) or severe intensity (EDSS increase > 3 points)

    • If EDSS previous relapse is available:

      • optic neuritis, myelitis or brainstem relapse: the EDSS should increase of 1 point in visual, pyramidal or brainstem system function
      • relapse in other location or uncertain location: the EDSS should increase at least 1 point

    • If EDSS previous relapse is not available:

      • optic neuritis, myelitis or brainstem relapse: the visual, pyramidal or brainstem system function should be > 2 points.
      • relapse in other location or uncertain location: EDSS should be > 2 points
  4. Recent clinical relapse onset (<15 days) without fever
  5. One month of clinical stability prior to relapse
  6. Signed informed consent
  7. Capacity to ingest the medication.

Exclusion Criteria:

  1. Doubts about the diagnosis of multiple sclerosis
  2. First episode of inflammatory neurological disease
  3. Secondary progressive MS or primary progressive MS
  4. Symptoms with lasted less than 24 hours of evolution
  5. Any degree of subjective or objective remission
  6. Treatment with corticosteroids during the previous 30 days
  7. Patients with immunosuppressive treatment (azathioprine, mitoxantrone, cyclophosphamide) or Natalizumab or Fingolimod
  8. Pregnancy or breastfeeding women or women of childbearing potential not using contraceptive measures
  9. Diseases with a contraindication of treatment with corticosteroids
  10. History of serious adverse reaction or hypersensitivity to drugs related to study medication
  11. Patients who could not be regular MRI, not collaborators or who requires anesthesia.
  12. Lactose intolerance
  13. Patients with allergies to contrast used in MRI
  14. Patients with renal impairment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986998


Locations
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Spain
Hospital Universitari Germans Trias I Pujol de
Badalona, Barcelona, Spain, 08916
Hospital Del Mar
Barcelona, Spain, 08003
Hospital de Mataró
Barcelona, Spain, 08034
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Hospital de Sant Joan Despí Moisés Broggi
Barcelona, Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Spain, 17007
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Spain, 25198
Hospital de Sant Pau I Santa Tecla
Tarragona, Spain
Sponsors and Collaborators
Germans Trias i Pujol Hospital
Investigators
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Principal Investigator: Cristina Ramo, MD Germans Trias i Pujol Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cristina Ramo, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT01986998    
Other Study ID Numbers: oral-CORTEM
2012-001965-34 ( EudraCT Number )
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Keywords provided by Cristina Ramo, Germans Trias i Pujol Hospital:
Multiple sclerosis relapse
oral methylprednisolone
EDSS
gadolinium
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Recurrence
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
 Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal