IVIGSe
- Conditions
- Idiopathic painful small fiber neuropathy or sensory neuronopathy.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2022-501717-31-00
- Lead Sponsor
- Sorlandet Sykehus HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
18-65 years, Painful sensory neuropathy fulfilling diagnostic criteria for idiopathic small fiber neuropathy or idiopathic sensory neuronopathy, Pain intensity at least 5.0 on Numeric Rating Scale (NRS) lasting at least 4 weeks, Signed written informed consent
Change of pain medication in the 30 days prior to inclusion, Treatment with IVIG or other immunomodulatory agents the last 4 weeks, Contraindications to IVIG ie previous stroke, myocardial infarction, or other thrombotic events, hypertension (uncorrected), smoking, diabetes, prolonged immobilization, hypercoagulable state, IgA deficiency, renal failure, ongoing heart disease, hypovolemia, previous allergic reactions to IVIG, Females who are breastfeeding, pregnant, or unwilling to practice adequate contraception throughout the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method