Multiple Sclerosis MedDRA version: 9.1 Level: SOC Classification code 10029205 Term: Nervous system disorders
Conditions
Interventions
Trade Name: COPAXONE
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Glatiramer acetate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade
Sponsors
ISTITUTO C. MONDINO
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; to correlate MR parameters related to the primary objectives with neurophysiological parameters; to evaluate the congruity of MR parameters comparing 1.5 and 3 Tesla;Primary end point(s): . evaluation of blood-brain barrier permeability . evaluation of spectroscopic parameters (NAA/Cho; NAA/Cr) | — |
Countries
Italy
Outcome results
None listed