[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530148":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":44,"locations":49,"responsibleParty":55,"collaborators":57,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":49,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":49,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":98,"whyStopped":49,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":49},{"fullName":5,"class":6},"Sorlandet Hospital HF","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous Immunoglobulin","EXPERIMENTAL","3 courses Intravenous immunoglobulin, Infusion solution, 100mg\u002Fml, 2g\u002Fkg over 3 days",[13],"Drug: Intravenous immunoglobulin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","3 courses Saline infusion solution 0,9%, same volume as IVIG over 3 days",[19],"Drug: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Intravenous immunoglobulin","Each patient will during the 30-week trial period get 3 IVIG courses (each total dose 2g\u002Fkg) for three consecutive days",[9],[27,28],"IVIG","Privigen",{"type":22,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"Each patient will during the 30-week trial period get 3 placebo courses (each 0.9% saline similar volume) for three consecutive days",[15],[33],"0.9% saline",[35,39,42],{"name":36,"affiliation":37,"role":38},"Jon-Marius Ørnes, Cand.med","Sorlandet Hospital HF, Department of Neurology","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":37,"role":41},"Unn Ljøstad, Cand.med PhD","STUDY_DIRECTOR",{"name":43,"affiliation":37,"role":41},"Åse Mygland, Cand.med PhD",[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Ørnes","CONTACT","+47 38125396",null,"Jon-Marius.Rognhaug.Ornes@sshf.no",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Unn Ljøstad","+47 38073908","Unn.Ljostad@sshf.no",{"type":56,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[58,61,63],{"name":59,"class":60},"Oslo University Hospital","OTHER",{"name":62,"class":60},"University Hospital of North Norway",{"name":64,"class":60},"University Hospital of Saint-Etienne","100530148","phase-4-ivig-in-painful-sensory-neuropathy-100530148",false,"NCT06183008","IVIG in Painful Sensory Neuropathy","Effect of Intravenous Immunoglobulins on Painful Sensory Neuropathy Evaluated by Aggregated N-of-one Trials","Inclusion Criteria:\n\nPainful sensory neuropathy fulfilling diagnostic criteria for idiopathic small fiber neuropathy or sensory neuronopathy\n\n* Idiopathic small fiber neuropathy (all of the following)\n\n  1. Neuropathic pain (length-dependent\u002Fnon-length dependent\u002Ffocal) and at least two of the following clinical signs\n\n     1. Hypoesthesia (tactile, pinprick, or thermal)\n     2. Allodynia (tactile, dynamic, thermal, pressure)\n     3. Hyperalgesia\n     4. Aftersensation\n  2. Normal nerve conduction studies:\n  3. Reduced intra-epidermal nerve fiber density at the distal leg (IENFD) at the distal leg or Reduced thermal threshold assessed at the foot by QST\n  4. Causal investigation according to clinical guidelines has not revealed a cause of the neuropathy\n* Sensory neuronopathy (all of the following)\n\n  1. Clinical pure sensory neuropathy\n  2. A score \\>6.5 on the following\n\n     1. Ataxia in the lower or upper limb: 3.1p\n     2. Asymmetrical distribution of sensory loss: 1.7p IVIGSeN Protocol number 1.2\n     3. Sensory loss not restricted to the lower limb at full development: 2.0 p\n     4. At least 1 sensory action potential absent or 3 sensory action potentials \\\u003C30% of the lower limit of normal in the upper limbs not explained by entrapment neuropathy: 2.8p\n     5. Less than two nerves with abnormal motor nerve conduction studies in the lower limbs: 3.1p\n  3. Causal investigation according to clinical guidelines has not revealed a cause of the neuropathy\n\nPain intensity \\> 5.0 on a pain score from 0-10, lasting at least 4 weeks\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions\n\n1. Previous allergic reaction to IVIG or other blood products)\n2. Selective IgA deficiency\n3. Cardiac insufficiency (NYHA III\u002FIV ie marked or severe limitation in activity due to symptoms, even during less-than-ordinary activity)\n4. Cardiac dysrhythmia requiring treatment\n5. Unstable or advanced ischemic heart disease\n6. Severe hypertension (diastolic \\>120 or systolic \\> 170)\n7. Known hyperviscosity\n8. Renal insufficiency (GFR \\\u003C 30 ml\u002Fmin\u002F1,73m2) or nephrotic syndrome\n9. Previous thromboembolic event\n10. Smoking\n11. Diabetes\n12. Prolonged immobilization\n13. Hypercoagulable state\n\n    Prior\u002FConcomitant Therapy\n14. Change of pain medication in the 30 days prior to inclusion (unchanged pain medication is allowed, provided dosages stay equal during the study)\n15. Treatment with IVIG the last 4 weeks or other ongoing immunomodulatory treatments\n16. Use of loop diuretics, Dinutuksimab beta, or Imlifidase Diagnostic assessments\n17. Predominant clinical or neurographic features of motor nerve fiber involvement Other Exclusions\n18. Females who are breastfeeding, pregnant or unwilling to practice contraception throughout the study\n19. Unable to give independent informed consent","ALL","18 Years","65 Years",{"count":76,"type":77},20,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","The goal of this clinical trial is to assess effect of Intravenous immunoglobulins (antibodies) as compared to Placebo, on pain intensity in patients from 18-65 years with painful sensory neuropathy without a known cause. Effect of the treatment will be recorded by the patient in a digital diary.",[83,84],"Sensory Neuropathy","Small Fiber Neuropathy",[86,87,88,89,90,91,27,23,92,93,94,95,96,97],"nervous system diseases","neuromuscular diseases","peripheral nervous system diseases","small fiber neuropathy","sensory neuronopathy","sensory neuropathy","n-of-1","Sørlandet sykehus","Sorlandet hospital","Kristiansand","polyneuropathy","Intravenous immune globulin","NOT_YET_RECRUITING","2023-12-13",{"date":101,"type":102},"2023-12-27","ACTUAL",{"date":104,"type":77},"2024-02",{"date":106,"type":77},"2028-12",{"name":5,"class":6}]