Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People who have been diagnosed with pure small fiber neuropathy (with or without problems affecting the autonomic nervous system, which controls things like heart rate and digestion), confirmed by both clinical assessment and a skin biopsy taken within the last 12 months
• People whose skin biopsy showed a reduced number of small nerve fibers, tested using a specific marker called PGP 9.5 (if the biopsy was not done at the trial's own laboratory, it will be repeated at three specific body sites for consistency)
• People who have had a blood test within the last 12 months showing abnormal levels of certain immune proteins (autoantibodies) called TS-HDS-IgM, FGFR3-IgG, or Plexin-D1, as measured by a specific laboratory at Washington University in St Louis
• People with a pain score of at least 4 out of 10 on a standard pain rating scale at the start of the trial
• People with a score of at least 4 out of 10 on a specific nerve assessment scale called the Utah Early Neuropathy Scale at the start of the trial
• People with a score of 11 or more out of 84 on a small fiber neuropathy symptom checklist
• Women who are not pregnant and not breastfeeding; women who could become pregnant must agree to use two forms of contraception or to completely avoid heterosexual sex throughout the treatment period

Who may not be able to join:

• People whose small fiber neuropathy has a known cause other than the specific autoantibodies listed above
• People with a serious, widespread muscle or joint condition (other than small fiber neuropathy itself) that would prevent a proper physical assessment by the doctor
• People whose nerve conduction tests show damage to the larger nerve fibers (this would be confirmed by the lead doctor of the study)
• People with serious heart, kidney, or liver disease, or HIV infection (note: if no HIV test result is on record from the past five years, a test may need to be done to confirm eligibility — confirm with trial site)
• People who have had a blood clot in a deep vein (such as in the leg) within the past year, or a blood clot in the lungs at any point in their life, or people considered to have an increased risk of developing blood clots
• People with a known significant deficiency of a specific immune protein called IgA, combined with antibodies that react against IgA
• People with a known history of a serious allergic reaction, including anaphylaxis or a severe whole-body response, to immunoglobulin treatments, blood or plasma products, or any ingredient in the study treatment (IVIG 10%)
• People with known conditions that cause the blood to be thicker than normal or that increase the tendency for blood to clot
• People who have received IgG treatment products within the six months before joining the trial
• People with a history of drug or alcohol misuse within the past five years
• People who are unable to understand the study requirements, or who are unwilling or unable to follow the study plan

Important: Always verify eligibility with the trial site directly before applying.