Intravenous immunoglobulin therapy for small fiber neuropathy: a randomized, double-blind, placebo-controlled study on efficacy and safety.
- Conditions
- small fiber neuropathy10034606
- Registration Number
- NL-OMON47574
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
* 18 years or older.
* Skin-biopsy proven idiopathic SFN or idiopathic painful neuropathy with predominantly SFN pattern
* Pain intensity rated * 5 on the PI-NRS (maximum pain) or on the neuropathic pain scale question number 1 for at least 12 weeks before the study as declared by each patient to the best of their knowledge; if available, medical records of each patient will be consulted on the reported pain intensity.
* Each subject will receive an information leaflet and an informed consent form. Subjects must give informed consent by signing and dating prior to study entry.
* Eligible patients must be willing to complete all study-related activities and examination required by the protocol.
Patients will be excluded if they:
* Are unable or unwilling to provide written informed consent.
* Have predominant clinical picture of large nerve fiber involvement (i.e., weakness, loss of vibration sense, hypo-/areflexia).
* Had treatment with IVIg or any other immunomodulatory/immunosuppressive agents (e.g., steroids) within the last 12 weeks prior to the date of informed consent.
* Have an underlying cause of SFN (diabetes, SCN9A/10A/11A mutations, hypothyroidism, renal failure, vitamin B12 deficiency, monoclonal gammopathy, alcohol abuse (more than 5 IU/day), malignancies, drugs that cause neuropathy (e.g. chemotherapy, amiodarone, propafenone)).
* Have a history of anaphylaxis or severe systemic response to immunoglobulin or with a blood product.
* Have cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, or history of congestive heart failure, severe hypertension (diastolic blood pressure >120 mmHg or systolic >170 mmHg).
* Are females who are pregnant, breast-feeding, or if of childbearing potential, or unwilling to practice adequate contraception throughout the study.
* Have known hyperviscosity.
* Have a history of renal insufficiency or high serum creatinine levels .
* Have known selective IgA deficiency.
* Have conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome).
* Have a known hypercoagulable state.
* Are mentally challenged adult subjects unable to give independent informed consent.
* The use of pain (analgesic/anti-neuropathic) medication is allowed, but only if dosages are remained unchanged for at least 30 days prior to randomization. A change in dosage of these drugs will not be allowed throughout the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the comparison of the percentage of responder subjects<br /><br>between the two treatment groups from the first randomization during 12 weeks<br /><br>treatment. A responder is defined as * 2 points PI-NRS improvement on the mean<br /><br>weekly peak pain relative to baseline.</p><br>
- Secondary Outcome Measures
Name Time Method