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.
Patients suffering from idiopathic sensory neuropathies often report excruciating pain that interferes with daily function and leads to impaired quality of life. Current neuropathic pain treatment options are in general insufficient. Autoimmunity may play a role in some patients, and treatment with intravenous immunoglobulins (IVIG) may have a potential beneficial effect. Available scientific documentation on this topic is limited and disparate. The main purpose of this trial is to assess effect of IVIG as compared to placebo on pain intensity in patients \>18 years with idiopathic painful small fiber neuropathy or sensory neuronopathy. Each patient will during the 30-week trial period get 3 IVIG courses and 3 placebo courses in a randomized order, given every 5 week on an outpatient basis for three consecutive days. Outcome measures will be recorded by the patient in a digital diary
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Each patient will during the 30-week trial period get 3 IVIG courses (each total dose 2g/kg) for three consecutive days
Each patient will during the 30-week trial period get 3 placebo courses (each 0.9% saline similar volume) for three consecutive days
Pain intensity the second week
Pain intensity after IVIG/Placebo infusions scored on a numeric rating scale (NRS) ranging from 0 to 10
Time frame: The second week after start of IVIG/Placebo infusions (mean of days 8, 10 and 13)
Pain intensity across 4 weeks
Pain intensity across 4 weeks after start of each infusion (mean of scoring three times per week from)
Time frame: Day 8 to 34 after start of each infusion
Disability and quality of life
Scored on: Polyneuropathy Patient-reported Index (CAPPRI)
Time frame: At the end of the third week after infusion
Anti-FGF3 antibodies
Blood samples will be tested for anti-FGF3 antibodies to evaluate their association with the observed clinical response in terms of pain relief to IVIG.
Time frame: Before start of infusion of IVIG/Placebo week 1, 5, 11, 16, 21 and 26
Adverse events
Recording adverse events
Time frame: From start to end of interventions week 1 - 30
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