Plain-English translation of NCT04153422 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing intravenous immunoglobulin (IVIG)—a treatment made from donated antibodies—to see if it can reduce pain and improve nerve fiber health in people with autoimmune small fiber neuropathy. Small fiber neuropathy is a condition where the smallest nerves in your body become damaged, causing burning pain and other symptoms. The medication works by helping your immune system calm down and stop attacking your own nerves.
Right now, there's no proven standard treatment for autoimmune small fiber neuropathy, and doctors often turn to long-term steroids that come with serious side effects. Early evidence suggests this treatment may reduce pain and actually help nerve fibers heal, but it has never been properly tested in a controlled study to prove it really works.
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If you join this trial, you will receive intravenous infusions every 4 weeks for 24 weeks (6 doses total), given over 2 days each time. Half of participants will receive the active treatment (IVIG) and half will receive a placebo saline infusion—neither you nor your doctor will know which one you're getting. You'll have skin biopsies and other tests at the start and after 6 months to measure whether your nerve fibers are improving and your pain is decreasing.
AI-generated summary from trial data · Jun 13, 2026 · Not medical advice
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