Status:
COMPLETED
Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse
Lead Sponsor:
Germans Trias i Pujol Hospital
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
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 atta...
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 (M...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00753792
Start Date
November 1 2008
End Date
January 1 2011
Last Update
June 2 2011
Active Locations (7)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
2
Hospital de Mataró
Barcelona, Barcelona, Spain, 08034
3
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
4
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain, 08036