NCT06183008

IVIG in Painful Sensory Neuropathy

Effect of Intravenous Immunoglobulins on Painful Sensory Neuropathy Evaluated by Aggregated N-of-one Trials

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sorlandet Hospital HF · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Sensory Neuropathy
• Small Fiber Neuropathy

Interventions

Type	Name	Description
DRUG	Intravenous immunoglobulin	Each patient will during the 30-week trial period get 3 IVIG courses (each total dose 2g/kg) for three consecutive days
DRUG	Placebo	Each patient will during the 30-week trial period get 3 placebo courses (each 0.9% saline similar volume) for three consecutive days

Timeline

• Start date: 2024-02-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2023-12-27
• Last updated: 2023-12-27