Clinical trial NCT00753792: Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
relapse
methylprednisolone
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2008-09-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis
timeFrame: day 28
measure: Change in EDSS in patients who present a relapse from different type or unknown topography
timeFrame: day 28
Secondary outcomes:
measure: Change in the punctuation in each group
timeFrame: between days 7 and 0
measure: Percentage of patients who improve, get worse and keep stable
timeFrame: days 7 and 28
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias i Pujol Hospital
state: Barcelona
city: Figueres
country: Spain
facility: Hospital de Figueres
state: Girona
city: Barcelona
country: Spain
facility: Hospital de Mataró
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Girona
country: Spain
facility: Hospital Dr. Trueta
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Cristina Ramo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.