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Study on the Effect of Human Normal Immunoglobulin and Sodium Chloride on Pain Relief in Patients with Idiopathic Painful Sensory Neuropathy

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for a condition known as idiopathic painful small fiber neuropathy or sensory neuronopathy. These are conditions that cause pain due to damage to the small nerve fibers, which can affect sensation. The treatment being tested is called Privigen, which is a solution containing human normal immunoglobulin. This is a type of protein that is usually found in the blood and helps the immune system fight infections. The study will also use a placebo for comparison purposes.

The purpose of the study is to investigate whether Privigen can help reduce pain in patients with these nerve conditions. Participants in the study will receive the treatment through an intravenous infusion, which means the solution is given directly into a vein. The study will last for several weeks, during which participants will receive the treatment and have their pain levels monitored. The goal is to see if there is a noticeable reduction in pain after receiving the treatment compared to the placebo.

Throughout the study, participants will be asked to report their pain levels and any changes in their quality of life. This information will help researchers understand the effectiveness of Privigen in managing pain associated with these nerve conditions. The study will also monitor for any side effects or adverse events that may occur during the treatment period. By the end of the study, researchers hope to gather enough data to determine if Privigen is a beneficial treatment option for patients with idiopathic painful small fiber neuropathy or sensory neuronopathy.

1 joining the study

Upon joining the study, you will be asked to confirm your eligibility. This includes being between 18 and 65 years old, having a painful sensory neuropathy with a pain intensity of at least 5.0 on a numeric rating scale, and having experienced this pain for at least 4 weeks. You will also need to provide signed written consent.

2 initial assessment

An initial assessment will be conducted to evaluate your current health status and pain levels. This will help establish a baseline for the study.

3 treatment phase

You will receive an infusion of Privigen 100 mg/ml solution for infusion, which contains human normal immunoglobulin, administered intravenously. The frequency and duration of the infusion will be determined by the study protocol.

In addition to the main treatment, you may also receive a saline solution, which is a simple saltwater solution, as part of the study procedures.

4 pain assessment

Your pain intensity will be assessed during the second week after the start of the infusions. This will involve scoring your pain on a numeric rating scale on days 8, 10, and 13.

5 ongoing monitoring

Throughout the study, your pain intensity will be monitored over a period of 4 weeks after each infusion. This will involve scoring your pain three times per week from day 8 to day 34.

Your disability and quality of life will also be evaluated at the end of the third week after the infusion using a specific index designed for patients with polyneuropathy.

6 final assessment

At the end of the study period, a final assessment will be conducted to evaluate the overall effects of the treatment on your pain, disability, and quality of life.

The presence of any adverse events or side effects will also be recorded.

Who Can Join the Study?

  • Age between 18 and 65 years old.
  • Have a condition called painful sensory neuropathy, which meets the criteria for either idiopathic small fiber neuropathy or idiopathic sensory neuronopathy. This means you have nerve pain without a known cause.
  • Experience pain with an intensity of at least 5.0 on a scale from 0 to 10, where 0 means no pain and 10 means the worst pain possible. This pain should have lasted for at least 4 weeks.
  • Provide a signed written consent form, indicating that you understand the study and agree to participate.

Who Cannot Join the Study?

  • Patients with any other known cause of neuropathy cannot participate. Neuropathy means nerve damage that causes pain, tingling, or numbness.
  • Patients who have received any other treatment for neuropathy in the last 3 months are not eligible.
  • Patients with a history of severe allergic reactions to blood products cannot join. Blood products are components derived from blood, like plasma.
  • Patients with uncontrolled medical conditions that could interfere with the study are excluded. Uncontrolled medical conditions are health issues that are not being managed well with treatment.
  • Pregnant or breastfeeding women cannot participate.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients with a history of drug or alcohol abuse in the past year are excluded.
  • Patients with a known history of HIV, hepatitis B, or hepatitis C infections cannot join. These are viral infections that affect the immune system and liver.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Sørlandet sykehus Kristiansand Kristiansand Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not yet recruiting
01.04.2025

Trial locations

Investigated drugs:

Intravenous Immunoglobulins (IVIG) are a therapy made from a mixture of antibodies that are given through a vein. Antibodies are proteins in your blood that help your body fight infections. In this trial, IVIG is being used to see if it can help reduce pain in people who have a specific type of nerve pain called idiopathic sensory neuropathy. This condition causes pain without a known cause, and the study is looking to see if IVIG can make the pain better.

Investigated diseases:

Idiopathic painful small fiber neuropathy – This condition involves damage to the small nerve fibers, which are responsible for transmitting pain and temperature sensations. It is characterized by chronic pain, often described as burning or tingling, primarily affecting the feet and hands. The disease progresses with persistent pain that can vary in intensity and may spread to other areas over time. Patients may also experience sensory disturbances, such as numbness or heightened sensitivity to touch. The exact cause of this neuropathy is unknown, which is why it is termed “idiopathic.” As the disease advances, it can lead to significant discomfort and impact daily activities.

Trial ID:
2022-501717-31-00
Trial Phase:
Therapeutic use (Phase IV)

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