Status:
COMPLETED
Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis
Lead Sponsor:
S. Andrea Hospital
Collaborating Sponsors:
Italian Multiple Sclerosis Foundation
Istituto Superiore di Sanità
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ...
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 demons...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Therapy with corticosteroids in the last month
- Plasmapheresis, 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 tubercular disease
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00202410
Start Date
November 1 2001
End Date
April 1 2008
Last Update
May 19 2011
Active Locations (1)
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1
Department of Neurology - University of Rome La Sapienza
Rome, Roma, Italy, 00100