ADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSM

Conditions: Multiple Sclerosis
MedDRA version: 9.1Level: SOCClassification code 10029205Term: Nervous system disorders

Registration Number: EUCTR2008-007162-32-IT

Lead Sponsor: ISTITUTO C. MONDINO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- relapsing-remitting Multiple Sclerosis patients elegible to treatment with Interferon beta 1-a (Avonex)i.m. or Glatiramer-acetate (copaxone) s.c
. age ≥ 18 years
. EDSS < 5.5
. ability to sign informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

. use of steroids and/or symptomatic drugs for fatigue within 30 days, other immunomodulatories within 3 months, immunosuppressant within 6 months
. cranial thrauma with sequelae
. concomitant partecipation to other clinical studies

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate modifications of MRI parameters related to inflammatory mechanisms; to evaluate modifications of MRI parameters related to neurodegenrative mechanisms;Secondary Objective: to correlate MR parameters related to the primary objectives with clinical parameters;<br>to correlate MR parameters related to the primary objectives with neurophysiological parameters;<br>to evaluate the congruity of MR parameters comparing 1.5 and 3 Tesla;Primary end point(s): . evaluation of blood-brain barrier permeability<br>. evaluation of spectroscopic parameters (NAA/Cho; NAA/Cr)

Secondary Outcome Measures