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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 28
Awards & highlights
Study Summary
This trial will enroll patients with small fiber neuropathy (SFN) to study the effects of an IVIG called Panzyga. Panzyga is approved by the FDA as a therapy for Primary humoral immunodeficiency (PI), Chronic immune thrombocytopenia (ITP), and Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults, but it has not been approved by the FDA for use in SFN.
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.Check my eligibility
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.See study design
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 belowSelect...
My lab tests show abnormal levels of specific autoantibodies.
Select...
I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
quantified change in intraepidermal nerve fiber density (IENFD)
Secondary outcome measures
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 moreTrial 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).
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Who is running the clinical trial?
Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,914 Total Patients Enrolled
Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,862 Total Patients Enrolled
Octapharma USA, Inc.UNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's requirements.My lab tests show abnormal levels of specific autoantibodies.I have not used IgG products in the last 6 months.I am not pregnant or breastfeeding.My small fiber neuropathy is not caused by anything other than novel auto-antibodies.I am 18 years old or older.Your Small Fiber Neuropathy Screening List score is 11 or higher.I have a confirmed diagnosis of small fiber neuropathy from a recent biopsy.Participants must have a Utah Early Neuropathy Scale (UENS) score of 4 out of 10 or higher before starting the study.You have a major IgA deficiency with antibodies to IgA.You have struggled with drug or alcohol abuse in the last five years.You have had a severe allergic reaction to blood products or IVIG 10%.I have had a deep vein thrombosis in the past year or a pulmonary embolism at any time.You must have a pain score of 4/10 or higher on a pain scale.I do not have severe musculoskeletal conditions that would interfere with my assessment.Tests show that you have nerve problems called polyneuropathy, as confirmed by the study doctor.You have a condition where your blood is too thick or prone to clotting.I do not have severe heart, kidney, liver disease, or HIV.I have a confirmed diagnosis of small fiber neuropathy from a biopsy taken within the last year.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Small Fiber Neuropathy Patient Testimony for trial: Trial Name: NCT04153422 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please provide insight into the possible risks of Panzyga IVIG?
"Panzyga IVIG is classified as a Phase 2 drug, meaning that while there is some evidence supporting its safety, there is none yet for its efficacy."
Answered by AI
Is there still room for people to participate in this research project?
"At present, this clinical trial is not recruiting patients. The original posting was on October 1st, 2022 and the most recent update was on August 22nd, 2022. There are 37 other trials looking for participants with Panzyga IVIG and 199 studies enrolling patients with small fiber neuropathy if you wish to explore other options."
Answered by AI
What conditions does Panzyga IVIG help ameliorate?
"The most common treatment for bruton's agammaglobulinemia is Panzyga IVIG. Additionally, this immunoglobulin can also ameliorate primary immunodeficiencies (pid), agammaglobulinemia, and chronic inflammatory demyelinating polyradiculoneuropathy."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Oregon
Illinois
Other
How old are they?
18 - 65
What site did they apply to?
Northwest Community Healthcare
Henry Ford Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
Why did patients apply to this trial?
I receive emails inviting me for some studies, from your company, but never have.
PatientReceived 1 prior treatment
Extremely difficult to find care for small fiber neuropathy and the pain is excruciating and debilitating.
PatientReceived 2+ prior treatments
I’ve been misdiagnosed for 13 years and have been dismissed by doctor after doctor and I have don’t nothing but suffer and I’ve taken more medications and failed them all. Not to say the significant and high risk adverse reactions. This is my last option available to get any kind of possibly relief.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
- Henry Ford Health: < 48 hours
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