Bacille-Calmette-Guerin (BCG) vaccine for multifocal motor neuropathy (MMN) and multifocal acquired demyelinating sensory and motor neuropathy (MADSAM).

Not Applicable

• Conditions: Multifocal motor neuropathy; Multifocal acquired demyelinating sensory and motor neuropathy (sometimes called asymmetric chronic inflammatory demyelinating polyradiculoneuropathy or Lewis Sumner syndrome); Neurological - Other neurological disorders; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12618001936213
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-28
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Fulfill EFNS criteria for definite or probable MMN or definite or probable atypical CIDP - MADSAM not benefitting from corticosteroids (no change or worsening)
2. Untreated or treatment with intravenous immunoglobulin and/or plasma exchange (MADSAM) acceptable

Exclusion Criteria

-Hyperergic on Mantoux reaction (induration greater than or equal to 5mm)
-Active or previously treated tuberculosis
-Current antituberculous therapy
-Active serious infection as determined by the treating clinician. If in doubt discuss with the safety committee. A patient can also be reconsidered at a later date.
-Previous serious adverse event to BCG
-Concurrent BCG use for other purpose (including intravesical use)
-Significant leukopaenia i.e. lymphocytes < 1.0, neutrophils < 1.0
-HIV infection (serology within the last 12 months)
-Known congenital or other immunodeficiency
-Recent immunosuppressive medication including oral corticosteroids in the previous 2 months or rituximab or cyclophosphamide in the previous 12 months, or other antiproliferative agent in the previous 6 months, or other immunosuppressive agent used in combination or separately that is deemed by the treating physician to contribute to a significant immunocompromised state
-Any other condition in the opinion of the local investigator that could increase patient risk by participation in the study
-Serious comorbidity with a life expectancy of < 2 years
-Pregnant (check pregnancy test in people capable of conception in the month before BCG injection)
-Inability to provide consent or undertake assessments

Study & Design

• Study Type: Interventional
• Study Design: Not specified