MULTIPLE SCLEROSIS MedDRA version: 6.1 Level: PT Classification code 10028245
Conditions
Interventions
Trade Name: EPARMEFOLIN 30 CPR 0,1/0,5MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CALCIO FOLINATO DC.IT
CAS Number: 1492-18-8
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
AZIENDA OSPEDALIERA SAN CAMILLO FORLANINI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with RRMS according McDonald Criteria23 2. EDSS score between 0.0 and 5.5 3. Currently and for the first time treated with, and tolerating, Interferon beta subcutaneously, and having received this treatment for more than 3 but not more than 6 months. 4. Age between 18 and 50 years, included 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
Exclusion criteria: 2. Primary or secondary progressive MS 3. Pregnancy, a positive serum pregnancy test beta HCG at screen visit, a positive urine pregnancy test at baseline visit, or breast feeding 4. Uncontrolled, clinically significant heart diseases, such as dysrhythmias, angina, or uncompensated congestive heart failure 5. Uncontrolled Seizure disorder 6. Infections or any internal medical conditions that could threaten the general health of the patient in the short term. 7. Gastroresection 8. Prior diagnosis of neoplasia or mieloproliferative diseases. 9. Medical or psychiatric conditions that compromise the patient s ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of the association Cianocobalamine plus Calcium levofolinate and INFBvs. Placebo1 plus Placebo2 and INFBin patients with Relapsing-Remitting Multiple Sclerosis, evaluated by the increase of brain atrophy, measured as rate of volumetric changes of the whole-brain parenchyma on MRI scans after a treatment period of 24 months.;Secondary Objective: 1. Time to first relapse; 2. Relapse rate after 12 and 24 months of treatment versus baseline; 3. Number of patients relapse-free after 12 and 24 months of treatment; 4. Number of patients with confirmed increase of 1 point to EDSS for patients with range EDSS. 0.0 - 5.0; of 0.5 point for patients with EDSS at baseline 5.0 after 24 months of treatment; 5. Disability status evaluated by means of EDSS at baseline, 6, 12, 18 and 24 months versus screening; 6. Disability status evaluated by means of MSFC at 6, 12, 18, and 24 months versus screening; 7. Neuropsychological evaluation at screening, 12 and 24 months a. Attention digit span; Trail Making A B Stroop test ; b. Memory Rey auditory and Verbal lerning Test, Rey-Osterrieth complex figure c. Language phonemic categories d. Logic Thinking Raven Colored Progressive Matrices, e. Evaluation of Depression by means of Beck s Depression Inventory 8. Fatigue by means of the Multiple Sclerosis fatigue impact scal;Primary end point(s): Efficacy of the association Cianocobalamine plus Calcium levofolinate and INFBvs. Placebo1 plus Placebo2 and INFBin patients with Relapsing-Remitting Multiple Sclerosis, evaluated by the increase of brain atrophy, measured as rate of volumetric changes of the whole-brain parenchyma on MRI scans after a treatment period of 24 months. | — |
Countries
Italy
Outcome results
None listed