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

NCT01986998 | Completed Phase 4

• 2 other identifiers: oral-CORTEM2012-001965-34
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 8

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis relapse; oral methylprednisolone; EDSS; gadolinium

Outcome Measures

Primary Outcomes (1)

• Disability scale of Kurtzke EDSS score

  up to day 91

Secondary Outcomes (6)

• Adverse events / tolerability

  Baseline and day 29

• Disability scale of Kurtzke EDSS score

  Baseline and day 8

• 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

  day -1 and day 29

• Adverse events / tolerability

  Baseline and day 8

• Questionnaire MSQOL-54

  Baseline and day 8

Study Arms (2)

oMP 1250 mg: Group A

ACTIVE COMPARATOR

Methylprednisolone 1250 mg/24h x3 days

Drug: Methylprednisolone 1250 mg/24h x3 days

oMP 625 mg: Group B

ACTIVE COMPARATOR

Methylprednisolone oral 625 mg/24h x3 days

Drug: Oral Methylprednisolone 625 mg/24h x3 days

Interventions

Methylprednisolone 1250 mg/24h x3 days DRUG

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)

Also known as: Group A

oMP 1250 mg: Group A

Oral Methylprednisolone 625 mg/24h x3 days DRUG

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)

Also known as: Group B

oMP 625 mg: Group B

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Relapsing-remitting MS (Mc Donald criteria 2010) regardless being under immunomodulatory treatment
• EDSS (previous to relapse) between 0 and 5
• 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
• Recent clinical relapse onset (\<15 days) without fever
• One month of clinical stability prior to relapse
• Signed informed consent
• Capacity to ingest the medication.

You may not qualify if:

• Doubts about the diagnosis of multiple sclerosis
• First episode of inflammatory neurological disease
• Secondary progressive MS or primary progressive MS
• Symptoms with lasted less than 24 hours of evolution
• Any degree of subjective or objective remission
• Treatment with corticosteroids during the previous 30 days
• Patients with immunosuppressive treatment (azathioprine, mitoxantrone, cyclophosphamide) or Natalizumab or Fingolimod
• Pregnancy or breastfeeding women or women of childbearing potential not using contraceptive measures
• Diseases with a contraindication of treatment with corticosteroids
• History of serious adverse reaction or hypersensitivity to drugs related to study medication
• Patients who could not be regular MRI, not collaborators or who requires anesthesia.
• Lactose intolerance
• Patients with allergies to contrast used in MRI
• Patients with renal impairment

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (8)

Hospital Universitari Germans Trias I Pujol de

Badalona, Barcelona, 08916, Spain

Location

Hospital Del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de Mataró

Barcelona, Barcelona, 08034, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital de Sant Joan Despí Moisés Broggi

Barcelona, Barcelona, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta

Girona, Girona, 17007, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, Lleida, 25198, Spain

Location

Hospital de Sant Pau I Santa Tecla

Tarragona, Tarragona, Spain

Location

Related Publications (1)

• Hervas-Garcia JV, Ramio-Torrenta L, Brieva-Ruiz L, Batlle-Nadal J, Moral E, Blanco Y, Cano-Orgaz A, Presas-Rodriguez S, Torres F, Capellades J, Ramo-Tello C. Comparison of two high doses of oral methylprednisolone for multiple sclerosis relapses: a pilot, multicentre, randomized, double-blind, non-inferiority trial. Eur J Neurol. 2019 Mar;26(3):525-532. doi: 10.1111/ene.13851. Epub 2018 Nov 16.

  PMID: 30351511 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic 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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cristina Ramo

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: November 19, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 3, 2016

Record last verified: 2016-06

Locations

ES (8)