Neurologic clinical trials - Grifols Harvard SFN

Status:

Open (Study open and enrolling)

ClinicalTrials.gov:

NCT03401073

CONDITION(S): Small Fiber Neuropathy; IVIg - TRIAL: Grifols Harvard SFN - IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3.

A Double-Blind, Placebo Controlled Trial of Intravenous Immunoglobulin Therapy in Patient With Small Fiber Neuropathy Associated With Autoantibodies to TS-HDS and FGFR3

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.

Drug

Drug: Intravenous immunoglobulin, .9% Sodium Chloride

Trial Type

Interventional

Condition

Small Fiber Neuropathy immune globulin (IVIg)

Keywords

Idiopathic Peripheral Neuropathy | Small Fiber Neuropathy | immune globulin (IVIg)