IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3 (NCT03401073) | Clinical Trial Compass
CompletedPhase 2
IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3
United States20 participantsStarted 2018-09-01
Plain-language summary
The objective of this study is to develop a rationale for the selective treatment of small fiber neuropathy with immune globulin (IVIG) in the appropriate patients.
The investigators hypothesize that individuals with auto-antibodies targeting neuronal antigens (TS-HDS and FGFR3) and confirmed evidence of small fiber neuropathy (by skin biopsy analysis of intra-epidermal nerve fiber density) will have an improvement in both nerve fiber density and pain after treatment with immune globulin.
The co-primary endpoints will be a change in neuropathic pain (by VAS pain score) and a change in intra-epidermal nerve fiber density (by punch skin biopsy).
The data gained from this pilot study will establish a rationale, with an appropriate screening test, for the use of immune globulin for the treatment of small fiber neuropathy.
Who can participate
SexALL
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Inclusion criteria
✓. Patient with clinically evident and biopsy proven pure small fiber neuropathy as evidenced by reduced intra-epidermal nerve fiber density seen on skin biopsy using PGP 9.5 as the immunostain.
✓. Patients must have a baseline pain score on a VAS scale of Greater or equal to 4/10
✓. Patients must have elevated titers of autoantibodies to TS-HDS or FFR3 as measured in Dr Alan Pestronk's lab at Washington University in St Louis.
Exclusion criteria
✕. Any other known cause for small fiber neuropathy other than the presence of the elevated titers of auto-antibodies. For example patients with diabetes, HIV, Sjogrens, Vitamin deficiency etc.
✕. Patients with generalized, severe musculoskeletal conditions other than SFN that prevent a sufficient assessment of the patient by the physician
✕. Cardiac insufficiency (New York Heart Association III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease).
✕. Severe liver disease (ALAT 3x \> normal value).
✕. Severe kidney disease (creatinine 1.5x \> normal value).
✕
What they're measuring
1
The Change in Nerve Fiber Density Between Visits 1 and 8.
Timeframe: Visit 1 (time zero) and visit 8 (range of visit time 22-27 weeks after visit 1), thus a total of 22-27 weeks for the study (the range is provided to ensure final follow up is completed despite any conflicts with travel or holidays).
. Known hepatitis B, hepatitis C or HIV infection.
✕. Patients with a history of deep vein thrombosis (DVT) within the last year prior to baseline visit or pulmonary embolism ever; patients with susceptibility to embolism or deep vein thrombosis.