IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS or FGFR-3 Antibodies
Status:
Suspended
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
This study will enroll patients with small fiber neuropathy (SFN). The study will look at an
intravenous immunoglobulin (IVIG) called Gammagard. Gammagard is approved by the FDA as a
therapy for certain diseases that result from an impaired immune system and as a maintenance
therapy to improve sensation and strength in patients with Chronic Immune Demyelinating
Polyneuropathy (CIDP) and muscle strength in adults with Multifocal Motor Neuropathy (MMN).
It has not been approved by the FDA for use in this condition.
There is mounting evidence that Intravenous Immunoglobulin (IVIG) can cause pain reduction
and improve objective nerve fiber densities on skin biopsies in great numbers in SFN
patients. The primary outcome is quantified improvement in intraepidermal nerve fiber density
(IENFD) on repeat skin punch biopsy after 6 months of IVIG treatment.