Is NCT04153422 recruiting in Glenview, IL?

Yes, NCT04153422 is currently recruiting participants at its Glenview, IL location. This small fiber neuropathy clinical trial is actively enrolling qualified participants.

How do I join the small fiber neuropathy clinical trial in Glenview?

To join this clinical trial in Glenview, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Glenview clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Small Fiber Neuropathy Clinical Trial in Glenview, IL

About This Small Fiber Neuropathy Study in Glenview

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.

Sponsor: Endeavor Health

Who Can Participate

Inclusion Criteria

Patients ≥ age 18

Patient with clinical and biopsy evidence of pure small fiber neuropathy (with or without dysautonomia) as evidenced by reduced IENFD on skin biopsy using PGP 9.5 as the immunostain. Biopsy must have been performed within 12 months of study enrollment. If biopsies were not done at CRL, they will be repeated and done at 3 sites (upper and lower thigh, lower calf), to have consistent and equivalent biopsy data with the follow up biopsy done after 6 mos of treatment

Patients must have elevated and/or abnormal titers of autoantibodies to TS-HDS-IgM, FGFR3-IgG, or Plexin-D1 measured by the Washington University Neuromuscular Laboratory (St Louis) within 12 mos of enrollment

Patients must have a baseline pain score on a visual analogue scale (VAS) of Greater or equal to 4/10

Patients must have a baseline Utah Early Neuropathy Scale (UENS) score of Greater or equal to 4/10

Small Fiber Neuropathy Screening List (SFNSL) score of 11/84 or greater

Non-pregnant, non-lactating female. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during treatment

Exclusion Criteria

Any other known cause for small fiber neuropathy other than the presence of the elevated titers of TS-HDS-IgM, FGFR3-IgG, or Plexin-D1 autoantibodies

Patients with generalized, severe musculoskeletal conditions other than SFN that prevent a sufficient assessment of the patient by the physician

Electromyography/nerve conduction study (EMG/NCS) evidence of large fiber polyneuropathy, to be confirmed by study PI

Underlying severe heart, kidney, liver disease, or HIV infection, (Note: If there is no previous HIV test result documented within the last 5 years, a test may be performed in order to confirm eligibility)

Patients with a history of deep vein thrombosis within the last year prior to baseline visit or pulmonary embolism ever; patients with susceptibility to embolism or deep vein thrombosis

Known significant IgA deficiency with antibodies to IgA

History of hypersensitivity, anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products, or any component of IVIG 10%

Known blood hyperviscosity, or other hypercoagulable states

Use of IgG products within six months prior to enrollment

Patients with a history of drug or alcohol abuse within the past five years prior to enrollment

Patients unable to understand or unwilling or unable to comply with the study protocol

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Glenview?

Yes, this clinical trial (NCT04153422) has an active research site in Glenview, IL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Small Fiber Neuropathy Treatment Options in Glenview, IL

If you're searching for small fiber neuropathy treatment options in Glenview, IL, this clinical trial (NCT04153422) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Glenview research site is actively enrolling participants for this clinical trial. You'll receive care from experienced small fiber neuropathy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all small fiber neuropathy clinical trials near you to find additional studies recruiting in your area.

Small Fiber Neuropathy Clinical Trial in Glenview, IL

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