Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202410
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-12
Brief Title:
Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis
Sponsor:
S Andrea Hospital
Organization:
S Andrea Hospital
Study Overview
Official Title:
Phase 2-3 Use of Bacille Calmette-Guèrin BCG Vaccine in Patients With a First Clinical Demyelinating Episode a Multicenter Randomized Single Blind Study
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The frequency of auto-immune diseases including multiple sclerosis is increasing in industrialised countries
According to an hypothesis which is receiving a wide international credit this may be due to the fact that the populations of these countries are increasingly less exposed to microbes further to the improvement of hygienic conditions and to the use of antibiotics
If exposure to microbes is lacking also their regulatory function is missed with a consequent possible onset of auto-immune symptoms
For this reason it is deemed that by exposing the immune system of a patient to an ancient microbe being complex and important in man evolution like the Tuberculosis Mycobacterium it is possible to rebalance the immune system
According to an hypothesis which is receiving a wide international credit this may be due to the fact that the populations of these countries are increasingly less exposed to microbes further to the improvement of hygienic conditions and to the use of antibiotics
If exposure to microbes is lacking also their regulatory function is missed with a consequent possible onset of auto-immune symptoms
For this reason it is deemed that by exposing the immune system of a patient to an ancient microbe being complex and important in man evolution like the Tuberculosis Mycobacterium it is possible to rebalance the immune system
Detailed Description:
Vaccination with the Tuberculosis Mycobacterium has proved to be effective in the animal model of multiple sclerosis experimental allergic encephalitis
In a study of phase I-II our group has demonstrated the safety of this therapy together with preliminary evidence
The study includes patients with an initial disease diagnosis supported by paraclinical criteria single clinical poly or mono-symptomatic attack in the 6 months preceding the study MR picture compatible with MS
Study design 100 randomized patients ie randomly assigned to be included either in a group of 50 patients undergoing therapy or to a group of 50 patients receiving placebo
Patients are followed up with monthly contrast MRI for 6 months At the end of the six months the disease activity in the group of treated patients is benchmarked with the disease activity of the group of patients receiving placebo
Safety is granted by the extremely wide diffusion of this kind of vaccination worldwide and by the previous study in patients affected by multiple sclerosis
In a study of phase I-II our group has demonstrated the safety of this therapy together with preliminary evidence
The study includes patients with an initial disease diagnosis supported by paraclinical criteria single clinical poly or mono-symptomatic attack in the 6 months preceding the study MR picture compatible with MS
Study design 100 randomized patients ie randomly assigned to be included either in a group of 50 patients undergoing therapy or to a group of 50 patients receiving placebo
Patients are followed up with monthly contrast MRI for 6 months At the end of the six months the disease activity in the group of treated patients is benchmarked with the disease activity of the group of patients receiving placebo
Safety is granted by the extremely wide diffusion of this kind of vaccination worldwide and by the previous study in patients affected by multiple sclerosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None