Radiologically Isolated Syndrome (Ris) MedDRA version: 20.0 Level: PT Classification code 10079292 Term: Radiologically isolated syndrome System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: BCG 10 Anti-Tuberculosis Vaccine
Product Name: BCG 10 Anti-Tuberculosis Vaccine
Product Code: [Non Disponibile]
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or
Sponsors
FONDAZIONE ITALIANA SCLEROSI MULTIPLA ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female of any race and > 18 years old. 2. Diagnosis of RIS (4) within the last five years. 3. Signed 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation. 2. Concomitant or previous use of immunosuppressive or immunomodulating treatment (except sporadic use of corticosteroids) within the last five years. 3. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, severe systemic mycotic infections, metabolic diseases or malignancies, primary or secondary immunodeficiencies as determined by medical history, physical exam, laboratory tests, chest X-ray, electrocardiogram (ECG), and Mantoux reaction or quantiferon test. 4. Any medical or psychiatric condition that may affect the subjects ability to give informed consent, or to complete the study, or if the subject is considered by the treating neurologist to be, for any other reason, an unsuitable candidate for this study. 5. Subjects with inability to successfully undergo MRI scans. 6. Concomitant radiotherapy. 7. Known hypersensitivity to any component of the vaccine. 8. Past bone marrow stem cell transplantation and organ transplantation. 9. Other vaccinations in the previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the cumulative number of new combined unique active lesions (CUAL; defined as new gadolinium T1-weighted lesions and non-enhancing new and newly enlarging T2-weighted lesions) on magnetic resonance imaging (MRI) scans over 1 year.;Secondary Objective: Secondary objectives: To evaluate the time to the first clinical event over the 3 years period. Exploratory secondary objectives -to evaluate the number of cortical lesions at 6 months, as well as at 1, 2 and 3 years; -to evaluate the Percentage of Brain Volume Changes (PBVC) at 6 months, as well as at 1, 2 and 3 years; -to evaluate the Cortical and white matter Volume Changes at 6 months, as well as at 1, 2 and 3 years; -to evaluate the Magnetization Transfer ratio (MTr) in lesions at 6 months, as well as at 1, 2 and 3 years; -to evaluate the Magnetization Transfer ratio (MTr) in normal-appearing brain at 6 months, as well as at 1, 2 and 3 years; -to evaluate the immune-metabolic profile at 6 months, as well as at 1, 2 and 3 years. Safety objectives To evaluate the overall safety and tolerability profile of BCG 10 Anti-Tuberculosis Vaccine administered intradermally in subjects with RIS diagnosis.;Primary end point(s): The primary endpoint of the study will be the cumulative number of CUAL on MRI scans over 1 year.;Timepoint(s) of evaluation of this end point: Over 1 year (12 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The time to the first clinical event over the 3 years period.; Exploratory endpoints: - Number of cortical lesions - Percentage of Brain Volume Changes (PBVC) - Cortical and white matter Volume Changes - Magnetization Transfer ratio (MTr) in lesions - MTr in normal-appearing brain - The immune-metabolic profile; Safety / tolerability endpoints: Adverse events occurring during the study and laboratory tests;Timepoint(s) of evaluation of this end point: Over the 3 years period.; The exploratory endpoints will be analyzed at 6 months, as well as at 1, 2 and 3 years; Any time during the whole study | — |
Countries
Italy
Contacts
Public ContactCentro Neurologico Terapie Sperimen
Azienda Ospedaliera S. Andrea di Roma
Outcome results
None listed