MULTIPLE SCLEROSIS MedDRA version: 15.1 Level: LLT Classification code 10028053 Term: MS System Organ Class: 100000004852
Conditions
Interventions
Trade Name: ENDOXAN BAXTER
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Cyclophosphamide
Concentration unit: mg/kg milligram(s)/kilogram
Concentration number
Sponsors
AZIENDA OSPEDALIERA DI PADOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: AGE: 12-40 YY DIAGNOSIS OF MULTIPLE SCLEROSIS ACCORDING TO INTERNATIONAL CRITERIA EDSS: 3-5.5 RAPID PROGRESSION, CLINICAL AND NEURORADIOLOGICAL, OF THE DISEASE IN THE PREVIOUS YEAR, DESPITE AT LEAST 6 MONTHS OF CONVENTIONAL THERAPIES Are the trial subjects under 18? yes Number of subjects for this age range: 0 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: PRIMARY AND SECONDARY PROGRESSIVE MS RECENT RELAPSE (WITHIN 30 DAYS) ONGOING IMMUNOMODULATORY TREATMENT IMMUNOSUPPRESSIVE THERAPY IN THE PREVIOUS 2 MONTHS OTHER SYSTEMIC OR INFECTIOUS DISEASES SEVERE MENTAL DISEASES PREGNANCY AND BREAST-FEEDING
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: SAFETY AND EFFICACY OF THE TREATMENT;Secondary Objective: NEW CLINICAL, IMAGING AND IMMUNOPATHOLOGICAL INFORMATION OF DESEASE.;Primary end point(s): SAFETY AND EFFICACY OF THE TREATMENT | — |
Countries
Italy
Outcome results
None listed