Just added this one to Phase II.
Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis
This study is currently recruiting patients.
Verified by S. Andrea Hospital July 2005
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.
Condition: Multiple Sclerosis
Intervention Drug: Bacille of Calmette-Guerin
Phase: Phase II/Phase III
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.
Further Study Details:
Primary Outcomes: number of gad-enhancing lesions in T1 at 1,2,3,4,5,6 months; number of lesions in T1 and new lesions in T2 at 1,2,3,4,5,6 months
Secondary Outcomes: volume of T2 lesions at 0 and 6 months; volume of T1 lesions (black holes) at 0 and 6 months
Expected Total Enrollment: 100
Study start: November 2001
Last follow-up: September 2006
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-sympotmatic attack in the 6 months preceding the study, MR picture compatible with MS.
Study design 100 randomized patients (i.e. 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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
* Patients with an initial disease (diagnosis supported by paraclinical criteria): single clinical poly or mono-sympotmatic attack in the 6 months preceding the study, MR picture compatible with MS
* Therapy with corticosteroids in the last month
* Plasmaspheresis, administration of gamma globulins in the last three months
* Serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams
* Evidence of infections
* Evidence of tubercolar disease
Italy, Roma - Department of Neurology - University of Rome La Sapienza, Rome, Roma, 00100, Italy; Recruiting
Giovanni Ristori, MD, Principal Investigator
Stefania Cannoni, MD, Sub-Investigator
Silvia Romano, MD, Sub-Investigator
http://www.clinicaltrials.gov/ct/show/N ... 0?order=51