IVIG in Painful Sensory Neuropathy

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Peripheral Nervous System Diseases
Sensory Neuropathy
Small Fiber Neuropathy

Clinical Trial Details

NCT number	NCT06183008
Study type	Interventional
Source	Sorlandet Hospital HF
Contact	Ørnes
Phone	+47 38125396
Email	Jon-Marius.Rognhaug.Ornes@sshf.no
Status	Not yet recruiting
Phase	Phase 4
Start date	February 2024
Completion date	December 2028

View Details

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