Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753792
• Other study ID #: CORTEM
• Secondary ID: 2007-000888-15
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2008
• Last updated: June 1, 2011
• Start date: November 2008
• Est. completion date: January 2011

Study information

• Verified date: June 2011
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• methylprednisolone
methylprednisolone 1.000 mg/day intravenous administration during three days
• methylprednisolone
methylprednisolone 1.250 mg/day orally administered during three days
• Placebo
Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital	Badalona	Barcelona
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de Mataró	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital de Figueres	Figueres	Girona
Spain	Hospital Dr. Trueta	Girona
Spain	Hospital Arnau de Vilanova	Lleida

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis		day 28	No
Primary	Change in EDSS in patients who present a relapse from different type or unknown topography		day 28	No
Secondary	Change in the punctuation in each group		between days 7 and 0	No
Secondary	Percentage of patients who improve, get worse and keep stable		days 7 and 28	No