Ignite Creation Date:
2024-05-06 @ 1:54 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04153422
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2019-11-04
Brief Title:
IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS FGFR-3 or Plexin D1 Antibodies
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Intravenous Immunoglobulin IVIG in the Treatment of Small Fiber Neuropathy Due to TS-HDS FGFR-3 or Plexin D1 Antibodies a Double Blinded Placebo-controlled Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will enroll patients with small fiber neuropathy SFN The study will look at an intravenous immunoglobulin IVIG called Panzyga Panzyga is approved by the FDA as a therapy for Primary humoral immunodeficiency PI in patients 2 years of age and older Chronic immune thrombocytopenia ITP in adults and Chronic inflammatory demyelinating polyneuropathy CIDP in adults It has not been approved by the FDA for use in SFN
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
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
Detailed Description:
Small fiber neuropathy SFN is an increasingly prevalent diagnosis in neurology and neuromuscular centers Modern diagnostic techniques including skin biopsies and autonomic nervous testing are helping to find SFN in many patients with undiagnosed pain syndromes including fibromyalgia The prevalence is rising for SFN and an immune etiology may underlie 19-34 of cases While there is no standard of care treatment current treatment strategies for SFN include long-term steroid therapy which come with a host of side effects 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 as well as improving validated questionnaire scores monitoring symptom burden and disability However neither IVIG nor any other immunosuppressant has been studied in a sufficiently powered and adequately dosed controlled randomized clinical trial to demonstrate efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None