IVIG for Small Fiber Neuropathy
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Loyola University
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot have used IgG products within six months prior to enrollment.
What data supports the idea that the drug for Small Fiber Neuropathy is an effective treatment?
The available research shows that intravenous immunoglobulin (IVIG) has been effective in treating various nerve-related conditions. For example, in patients with autoimmune small fiber polyneuropathy, IVIG has shown significant benefits. Additionally, in studies involving other conditions like chronic inflammatory demyelinating polyneuropathy (CIDP), IVIG improved grip strength and overall muscle function. While these studies focus on different conditions, they suggest that IVIG can be effective for nerve-related issues, which supports its potential use for Small Fiber Neuropathy.
12345What safety data exists for IVIG treatment in small fiber neuropathy?
IVIG is generally considered a safe treatment for neuropathies, including small fiber neuropathy, but it can have complications. Common mild reactions include infusion-related issues, which can often be managed by adjusting the infusion rate or using symptomatic medications. Serious adverse effects are rare but can include thromboembolic events, renal failure, anaphylaxis, or aseptic meningitis. Patients with IgA deficiency, preexisting renal insufficiency, or those using sucrose-containing IVIG preparations are at higher risk for certain complications. Screening for risk factors can help reduce these risks. In patients with autonomic dysfunction, aseptic meningitis or severe headaches are more common when IVIG is dosed traditionally.
15678Is the drug Gammagard IVIG, Panzyga IVIG, or Placebo a promising treatment for Small Fiber Neuropathy?
Yes, the drug Gammagard IVIG and Panzyga IVIG are promising treatments for Small Fiber Neuropathy. Research shows that intravenous immunoglobulin (IVIG) therapy has been effective in treating autoimmune forms of neuropathy, including small fiber neuropathy, by improving nerve function and reducing pain.
134910Eligibility Criteria
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.Inclusion Criteria
My lab tests show abnormal levels of specific autoantibodies.
I am not pregnant or breastfeeding.
I am 18 years old or older.
+5 more
Exclusion Criteria
I am willing and able to follow the study's requirements.
I have not used IgG products in the last 6 months.
My small fiber neuropathy is not caused by anything other than novel auto-antibodies.
+8 more
Participant Groups
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.
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).
Gammagard IVIG is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Gammagard for:
- Primary humoral immunodeficiency (PI)
- Chronic immune thrombocytopenia (ITP)
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Multifocal motor neuropathy
- Kawasaki disease
🇪🇺 Approved in European Union as Gammagard for:
- Primary immunodeficiency syndromes
- Chronic immune thrombocytopenia (ITP)
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Multifocal motor neuropathy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwest Community HealthcareArlington Heights, IL
Henry Ford HealthDetroit, MI
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Who Is Running the Clinical Trial?
Loyola UniversityLead Sponsor
Henry Ford Health SystemLead Sponsor
Octapharma USA, Inc.Collaborator
References
How We Treat Autoimmune Small Fiber Polyneuropathy with Immunoglobulin Therapy. [2019]Intravenous immunoglobulin therapy is FDA approved for the immune-mediated peripheral nerve disorders Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy. Immunoglobulin therapy has been used increasingly with significant efficacy in the treatment of patients with disabling autoimmune forms of dysautonomia, which are most often small fiber (autonomic and/or sensory) polyneuropathies. It is recognized by most who treat these disorders, however, that patients with autonomic dysfunction treated with intravenous immunoglobulin therapy develop aseptic meningitis or severe lingering headache more frequently than other patient populations when this therapy is dosed in the traditional fashion. We discuss our combined 27 years of experience with the use of immunoglobulin and other immune modulatory therapy in patients with autoimmune small fiber polyneuropathy.
Randomized, controlled crossover study of IVIg for demyelinating polyneuropathy and diabetes. [2020]To determine whether IV immunoglobulin (IVIg) is more effective than placebo at reducing disability in patients with diabetes and demyelinating polyneuropathy features.
Human immunoglobulin treatment of multifocal motor neuropathy and polyneuropathy associated with monoclonal gammopathy. [2019]Intravenous human immune globulin (IVIg) has been proposed for the treatment of various peripheral neuropathies that are considered to be immunemediated. The results are reported of an open trial conducted in multifocal motor neuropathy and polyneuropathy associated with monoclonal gammopathy. Six cases with multifocal motor neuropathy, selected on clinical and electrophysiological criteria (four of six patients also had significantly high anti-GM1 titres), received IVIg monthly, at doses varying from 1.6 to 2.5 mg/kg, over three to 13 months. The initial response to treatment was dramatic in 3/6 cases (with improvement of at least two grades on the MRC scale in the five more severely affected muscles). The final evaluation showed a good result in 4/6 cases, but the conduction blocks were not significantly reduced. In 13 other cases with polyneuropathy associated with IgM monoclonal gammopathy of unknown significance, IVIg was of benefit, with improvement of at least one grade on the Prineas score, in 4/7 cases previously treated with immunosuppression and 2/3 cases not treated before IVIg. In the last group of four patients with polyneuropathy and IgG monoclonal gammopathy, IVIg was followed by clinical improvement in the two cases with a chronic demyelinating polyneuropathy.
Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy. [2022]This is the first double-blind randomized controlled trial evaluating the efficacy and safety of IV immunoglobulin (IVIG) vs placebo in patients with idiopathic small fiber neuropathy (I-SFN).
Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies. [2021]Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].
Safety and Tolerability of Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy: Results of the ProCID Study. [2023]Label="BACKGROUND AND AIMS">The ProCID study evaluated the efficacy and safety of three doses of a 10% liquid intravenous immunoglobulin (IVIg) preparation (panzyga®) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). This report describes the safety findings.
Complications of Immunoglobulin Therapy and Implications for Treatment of Inflammatory Neuropathy: A Review. [2019]Intravenous Immunoglobulin (IVIg) forms a cornerstone of effective treatment for acute and chronic inflammatory neuropathies, with a class I evidence base in Guillain-Barré Syndrome (GBS), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and multifocal motor neuropathy (MMN). It is generally considered to be a safe therapy however there are several recognised complications which are reviewed in this article.
Intravenous gammaglobulin (IVIg) for treatment of CIDP and related immune-mediated neuropathies. [2019]Intravenous immune globulin (IVIg) is considered an effective and safe treatment for autoimmune neuropathies, especially in comparison to the alternative treatments such as corticosteroids, chemotherapy, and plasmapheresis. Patients are frequently given a standard induction dose of 2 g/kg, which may be followed by maintenance therapy as needed. Mild infusion-related reactions are frequent but these can often be controlled by slowing the infusion rate or by symptomatic medications. Serious adverse effects are rare and can include thromboembolic events, renal failure, anaphylaxis, or septic meningitis. Patients with IgA deficiency are at risk for anaphylaxis. Immobility, increased serum viscosity, and preexisting vascular disease can increase the risk for thromboembolic events. Preexisting renal insufficiency or the use of sucrose-containing IVIg preparations can increase the risk for renal failure, and patients with migraine are at risk for development of aseptic meningitis. Screening patients for risk factors that predispose to development of adverse events may reduce the incidence of complications.
Improvement of hemoglobin levels after a switch from intravenous to subcutaneous administration of immunoglobulin in chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy. [2017]Intravenous immunoglobulin (IVIG) is recommended treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) and multifocal motor neuropathy (MMN). Recent studies have demonstrated that subcutaneous immunoglobulin (SCIG) is feasible, safe, and effective in both disorders. IVIG leads to transient hemolysis and, consequently, we hypothesized that frequent small doses of SCIG exerts less hemolytic activity than a few larger doses of IVIG.
A double-blind placebo-controlled pilot study of immunoglobulin for small fiber neuropathy associated with TS-HDS and FGFR-3 autoantibodies. [2023]Small fiber neuropathies (SFN) have been associated with two autoantibodies, trisulfated heparin disaccharide (TS-HDS) and fibroblast growth factor receptor 3 (FGFR-3), and intravenous immune globulin (IVIG) has been suggested as a potential therapy. The study objective is to determine the efficacy of IVIG on nerve density, pain and neurologic examinations in patients with SFN associated with TS-HDS and FGFR-3 autoantibodies.