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New treatment option for Multiple Sclerosis
Official title Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)
ClinicalTrials.gov ID: NCT03888924
What this study is testing
What is Bacille Calmette-Guerin vaccine?
Bacille Calmette-Guerin vaccine is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for multiple sclerosis.
Also referred to as BCG 10 Anti-Tuberculosis Vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Multiple sclerosis (MS) witnessed relevant therapeutic progress in the last decade. Following the extraordinary progress in the treatment of relapsing-remitting (RR) multiple sclerosis (MS), two major unmet needs remain to be addressed by translational research in this field: progressive MS and the "dream" of a world free of MS.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female of any race and \> 18 years old.
- Diagnosis of RIS (4) within the last five years.
- Signed Informed Consent.
You likely can't join if
- Pregnancy or lactation.
- Concomitant or previous use of immunosuppressive or immunomodulating treatment (except sporadic use of corticosteroids) within the last five years.
- people with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation. Such...
- Any medical or psychiatric condition that may affect the people ability to give informed consent, or to complete the study, or if the subject is...
- people with inability to successfully undergo MRI scans.
- Concomitant radiotherapy.
See the full eligibility criteria
- Male and female of any race and \> 18 years old.
- Diagnosis of RIS (4) within the last five years.
- Signed Informed Consent.
- Pregnancy or lactation.
- Concomitant or previous use of immunosuppressive or immunomodulating treatment (except sporadic use of corticosteroids) within the last five years.
- people 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...
- Any medical or psychiatric condition that may affect the people 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...
- people with inability to successfully undergo MRI scans.
- Concomitant radiotherapy.
- Known hypersensitivity to any component of the vaccine.
- Past bone marrow stem cell transplantation and organ transplantation.
- Other vaccinations in the previous 4 weeks.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.