In short
Currently, there is 1 ongoing clinical trial investigating potential treatments for small fibre neuropathy. This trial is exploring the use of intravenous immunoglobulin (IVIG) therapy to reduce pain in patients with idiopathic painful sensory neuropathy, a condition affecting small nerve fibres that transmit pain and temperature sensations.
Clinical trial locations
Study on the Effect of Human Normal Immunoglobulin and Sodium Chloride on Pain Relief in Patients with Idiopathic Painful Sensory Neuropathy
This trial is investigating whether Privigen, a solution containing human normal immunoglobulin, can help reduce pain in patients with idiopathic painful small fibre neuropathy or sensory neuronopathy. These conditions cause chronic pain due to damage to small nerve fibres responsible for sensing pain and temperature.
Main inclusion criteria:
- Adults aged between 18 and 65 years
- Diagnosed with painful sensory neuropathy meeting criteria for either idiopathic small fibre neuropathy or idiopathic sensory neuronopathy
- Pain intensity of at least 5 out of 10 on a numeric rating scale
- Pain lasting for at least 4 weeks
- Able to provide signed written consent
Main exclusion criteria:
- Any other known cause of neuropathy
- Received treatment for neuropathy within the last 3 months
- History of severe allergic reactions to blood products
- Uncontrolled medical conditions that could interfere with the study
- Pregnant or breastfeeding women
- Currently participating in another clinical trial
- History of drug or alcohol abuse within the past year
- Known HIV, hepatitis B, or hepatitis C infection
Focus and goals: The primary goal of this study is to determine whether intravenous immunoglobulin therapy can effectively reduce pain in patients with these nerve conditions. Participants will receive the treatment through an intravenous infusion directly into a vein. Throughout the study period, researchers will monitor pain levels at multiple time points, particularly during the second week after treatment begins and continuing for 4 weeks after each infusion. The study will also assess how the treatment affects participants' disability levels and overall quality of life. Researchers will carefully track any side effects or adverse events that may occur during treatment.
Investigational drug: The trial uses Privigen, which contains human normal immunoglobulin administered intravenously. Immunoglobulins are proteins naturally found in blood that help the immune system fight infections. In this context, IVIG is being tested for its potential to modulate the immune system, reduce inflammation, and ultimately alleviate pain associated with these nerve conditions. A saline solution (saltwater) will be used as a placebo for comparison purposes.
Summary
Currently, research into treatments for small fibre neuropathy is limited, with only one ongoing clinical trial identified. This trial is being conducted in Norway and focuses specifically on testing whether intravenous immunoglobulin therapy can provide pain relief for patients with idiopathic painful sensory neuropathy. The study represents an important investigation into potential treatment options for patients experiencing chronic nerve pain without a known underlying cause. The trial's approach of using immunoglobulin therapy suggests researchers are exploring immune system modulation as a potential mechanism for pain reduction in these challenging conditions.
