What side effects are associated with this type of intervention?

Intravenous immunoglobulin (IVIG) treatments, such as Panzyga, are commonly used to modulate the immune system in conditions like Small Fiber Neuropathy (SFN). Known side effects of IVIG include headache, elevated liver enzymes, diarrhea, flu-like symptoms, sinusitis, back pain, abdominal pain, and pain in the arms or legs. More serious but less common side effects can include bradyarrhythmia, macular edema, liver injury, diminished respiratory function, and increased risk of infections. Patients should discuss these potential side effects with their healthcare provider to weigh the benefits and risks of IVIG therapy.

What prior FDA approvals exist?

Panzyga, an intravenous immunoglobulin (IVIG), is FDA-approved for treating Primary humoral immunodeficiency, Chronic immune thrombocytopenia, and Chronic inflammatory demyelinating polyneuropathy (CIDP). While it is not specifically approved for Small Fiber Neuropathy (SFN), there is mounting evidence suggesting that IVIG can reduce pain and improve nerve fiber densities in SFN patients. Other FDA-approved treatments for SFN are not mentioned in the provided context.

What other types of research exist?

Promising novel alternatives to Panzyga (IVIG) for Small Fiber Neuropathy patients include: 1) Rituximab, which targets B-cells and has shown potential in autoimmune conditions; 2) Cyclophosphamide, an immunosuppressant that may be used in severe cases; 3) Emerging biologics targeting specific immune pathways, such as those inhibiting cytokines involved in inflammation. Patients should discuss these options with their healthcare provider to determine the best course of treatment.

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Monoclonal Antibodies

IVIG for Small Fiber Neuropathy

Phase 2

Recruiting

Led By Lawrence Zeidman, MD, FAAN

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Non-pregnant, non-lactating female

Must not have

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

Any other known cause for small fiber neuropathy other than the presence of the elevated titers of the novel auto-antibodies.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 28

Summary

This trial will test a treatment called Panzyga on patients with small fiber neuropathy (SFN). SFN patients often suffer from undiagnosed pain, and current treatments have many side effects. Panzyga may help by reducing inflammation and improving nerve function, potentially reducing pain and increasing nerve density in the skin. Panzyga has been shown to be effective in treating various autoimmune neurological disorders and has potential benefits for managing neuropathic pain.

Who is the study for?

This trial is for adults over 18 with small fiber neuropathy (SFN) confirmed by skin biopsy and specific autoantibodies (TS-HDS-IgM, FGFR3-IgG, Plexin-D1). Participants must have moderate pain and no history of severe reactions to immunoglobulin or blood products, significant heart, kidney, liver disease, HIV infection or recent deep vein thrombosis.

What is being tested?

The study tests Panzyga IVIG's effectiveness in SFN patients. It compares the change in nerve fiber density after six months between those receiving Panzyga and a placebo. The goal is to see if Panzyga can reduce pain and improve nerve function.

What are the potential side effects?

IVIG treatments like Panzyga may cause side effects such as mild allergic reactions, headache, fatigue, muscle aches or more rarely severe ones like blood clots or anaphylaxis especially in individuals with known allergies to immune globulins.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lab tests show abnormal levels of specific autoantibodies.

Select...

I am not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am willing and able to follow the study's requirements.

Select...

My small fiber neuropathy is not caused by anything other than novel auto-antibodies.

Select...

I do not have severe musculoskeletal conditions that would interfere with my assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

quantified change in intraepidermal nerve fiber density (IENFD)

Secondary study objectives

Change in Small Fiber Neuropathy-Rasch Overall Disability Scale (SFN-RODS) score

Change in Small Fiber Neuropathy-Symptom Inventory Questionnaire (SFN-SIQ) score

Change in Utah Early Neuropathy Scale (UENS) examination scores

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment (IVIG)Experimental Treatment1 Intervention

Patients in the treatment arm will receive 2g/kg IVIG every 4 weeks (over 2 days, 1g/kg dose on Day 1 and 1g/kg dose on Day 2) for 24 weeks (6 doses total).

Group II: PlaceboPlacebo Group1 Intervention

Patients in the placebo arm will receive 0.9% NaCl infusions on the same schedule as the active treatment group (Day 1 and Day 2 every 4 weeks for 24 weeks total, (6 doses).

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intravenous immunoglobulin (IVIG) is a common treatment for Small Fiber Neuropathy (SFN) that works by modulating the immune system to reduce inflammation and improve nerve function. This is crucial for SFN patients as the condition often involves immune-mediated damage to small nerve fibers, resulting in pain and sensory disturbances. By reducing inflammation and modulating the immune response, IVIG can help alleviate symptoms and potentially improve nerve fiber density, offering relief and improved quality of life for patients.

Immunosuppressant and immunomodulatory treatments for multifocal motor neuropathy.Immunosuppressive treatment for multifocal motor neuropathy.Efficacy of intravenous immunoglobulin in patients with IgG monoclonal gammopathy and polyneuropathy.