[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100374281":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Endeavor Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (IVIG)","EXPERIMENTAL","Patients in the treatment arm will receive 2g\u002Fkg IVIG every 4 weeks (over 2 days, 1g\u002Fkg dose on Day 1 and 1g\u002Fkg dose on Day 2) for 24 weeks (6 doses total).",[13],"Drug: Panzyga IVIG",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","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).",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Panzyga IVIG","Immune Globulin Infusion 10% (Human)",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"0.9% NaCl prepared as the calculated dose equivalent volume to IVIG.",[15],[31],{"name":32,"affiliation":5,"role":33},"Lawrence Zeidman, MD, FAAN","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Anna Pham","CONTACT","8475034344","anna.pham@endeavorhealth.org",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":26},"May Aunaetitrakul","8475702570",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Glenview","Illinois","60026","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-87.78784,42.06975,{"lat":55,"lon":54},[58],{"name":36,"role":37,"phone":26,"phoneExt":26,"email":39},{"type":33,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Lawrence Zeidman","Director, Neuromuscular and Autonomic Division, Endeavor Health",[63],{"name":64,"class":65},"Octapharma USA, Inc.","UNKNOWN","100374281","phase-2-ivig-in-the-treatment-of-autoimmune-small-fiber-neuropathy-with-ts-hds-fgfr-3-or-plexin-d1-antibodies-100374281",false,"NCT04153422","IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies","Intravenous Immunoglobulin (IVIG) in the Treatment of Small Fiber Neuropathy Due to TS-HDS, FGFR-3, or Plexin D1 Antibodies: a Double Blinded Placebo-controlled Phase II Trial","Inclusion Criteria:\n\n1. Patients ≥ age 18\n2. Patient with clinical and biopsy evidence of pure small fiber neuropathy (with or without dysautonomia) as evidenced by reduced IENFD on skin biopsy using PGP 9.5 as the immunostain. Biopsy must have been performed within 12 months of study enrollment. If biopsies were not done at CRL, they will be repeated and done at 3 sites (upper and lower thigh, lower calf), to have consistent and equivalent biopsy data with the follow up biopsy done after 6 mos of treatment\n3. Patients must have elevated and\u002For abnormal titers of autoantibodies to TS-HDS-IgM, FGFR3-IgG, or Plexin-D1 measured by the Washington University Neuromuscular Laboratory (St Louis) within 12 mos of enrollment\n4. Patients must have a baseline pain score on a visual analogue scale (VAS) of Greater or equal to 4\u002F10\n5. Patients must have a baseline Utah Early Neuropathy Scale (UENS) score of Greater or equal to 4\u002F10\n6. Small Fiber Neuropathy Screening List (SFNSL) score of 11\u002F84 or greater\n7. Non-pregnant, non-lactating female. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during treatment\n\nExclusion Criteria:\n\n1. Any other known cause for small fiber neuropathy other than the presence of the elevated titers of TS-HDS-IgM, FGFR3-IgG, or Plexin-D1 autoantibodies\n2. Patients with generalized, severe musculoskeletal conditions other than SFN that prevent a sufficient assessment of the patient by the physician\n3. Electromyography\u002Fnerve conduction study (EMG\u002FNCS) evidence of large fiber polyneuropathy, to be confirmed by study PI\n4. Underlying severe heart, kidney, liver disease, or HIV infection, (Note: If there is no previous HIV test result documented within the last 5 years, a test may be performed in order to confirm eligibility)\n5. Patients with a history of deep vein thrombosis within the last year prior to baseline visit or pulmonary embolism ever; patients with susceptibility to embolism or deep vein thrombosis\n6. Known significant IgA deficiency with antibodies to IgA\n7. History of hypersensitivity, anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products, or any component of IVIG 10%\n8. Known blood hyperviscosity, or other hypercoagulable states\n9. Use of IgG products within six months prior to enrollment\n10. Patients with a history of drug or alcohol abuse within the past five years prior to enrollment\n11. Patients unable to understand or unwilling or unable to comply with the study protocol","ALL","18 Years",{"count":76,"type":77},20,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This study will enroll patients with small fiber neuropathy (SFN). The study will look at an intravenous immunoglobulin (IVIG) called Panzyga. Panzyga is approved by the FDA as a therapy for Primary humoral immunodeficiency (PI) in patients 2 years of age and older; Chronic immune thrombocytopenia (ITP) in adults and Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. It has not been approved by the FDA for use in SFN.\n\nThere is mounting evidence that Intravenous Immunoglobulin (IVIG) can cause pain reduction and improve objective nerve fiber densities on skin biopsies in great numbers in SFN patients. The primary outcome is quantified improvement in intraepidermal nerve fiber density (IENFD) on repeat skin punch biopsy after 6 months of IVIG treatment.",[83,84,85,86],"Small Fiber Neuropathy","Autoimmune Small Fiber Neuropathy","Inflammatory Polyneuropathy","Immune-Mediated Neuropathy",[83,88,89,90,91,92,93,94,95,96],"Neuropathy","Intravenous Immunoglobulin","IVIG","TS-HDS antibody","FGFR-3 antibody","FGFR3 antibody","Immune mediated small fiber neuropathy","Panzyga","Plexin D1 antibody","2026-01-07",{"date":99,"type":100},"2026-01-09","ACTUAL",{"date":102,"type":100},"2023-12-15",{"date":104,"type":77},"2028-02-28",{"name":5,"class":6},1]