NCT00753792

Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Germans Trias i Pujol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	methylprednisolone	methylprednisolone 1.000 mg/day intravenous administration during three days
DRUG	methylprednisolone	methylprednisolone 1.250 mg/day orally administered during three days
DRUG	Placebo	Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-11-01
• Completion: 2011-01-01
• First posted: 2008-09-17
• Last updated: 2011-06-02

Locations

7 sites across 1 country: Spain