AuthorisedPhase II and Phase III (Integrated)Interventional

Effect of intravenous immunoglobulins on painful sensory neuropathy evaluated by aggregated N-of-one trials

This research is looking into how a treatment called intravenous immunoglobulins (IVIG) might help people suffering from painful nerve conditions, specifically small fiber neuropathy or sensory neuronopathy. These conditions can cause ongoing pain. The study aims to see if IVIG can reduce pain intensity, using a special design that helps us understand how individual people react to the treatment. We will compare IVIG to a placebo (a treatment with no active medicine) to understand its effects. Researchers will be carefully monitoring participants' pain levels, overall well-being, and any side effects. The goal is to find out if IVIG is a safe and effective way to help manage this type of pain.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Sorlandet Sykehus HF

Enrolment target

Start

09 Dec 2022

Idiopathic painful small fiber neuropathy or sensory neuronopathy.

What is this study about?

If you're living with ongoing pain due to conditions affecting your nerves, like small fiber neuropathy or sensory neuronopathy, you know how challenging it can be. This study is exploring a potential treatment called intravenous immunoglobulins, often shortened to IVIG. Immunoglobulins are proteins found in your blood that play an important role in your immune system, which helps your body fight off illness. In some nerve conditions, your immune system might be involved, and IVIG could potentially help calm down this immune activity, leading to less pain.

The main aim of this study is to see if IVIG can reduce the intensity of your pain. We'll be comparing it to a 'placebo', which looks exactly like the IVIG but doesn't contain any active medicine. This comparison is really important because it helps us truly understand if any improvements are due to the IVIG itself, rather than other factors. Each participant will get both IVIG and the placebo at different times, which is a clever way to see how you specifically respond to each treatment.

Throughout the study, we'll ask you to regularly rate your pain using a simple scale. We'll also check how the treatment might affect your daily activities and overall quality of life. Safety is very important, so we'll also be tracking any side effects you might experience. By doing this research, we hope to discover if IVIG could be a helpful and safe treatment option for people like you who are experiencing pain from these specific nerve conditions.

Key takeaways

This study investigates if IVIG can reduce pain in specific nerve conditions.
It uses a special design comparing IVIG to a placebo to ensure accurate results.
Pain levels, quality of life, and safety will be carefully monitored.
Open to adults aged 18 and over with idiopathic painful small fiber neuropathy or sensory neuronopathy.
Participation involves receiving IVIG or placebo via drip and regular pain assessments.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old. There's no upper age limit, so older adults are welcome to participate too. This study is open to both men and women.

The key requirement is that you must have been diagnosed with a specific type of nerve condition: either idiopathic painful small fiber neuropathy or sensory neuronopathy. "Idiopathic" simply means the cause of your condition is not currently known.

There will be other specific health checks to make sure the study is a good fit for you and that taking part would be safe. These checks might include reviewing your medical history and current medications. The study team will be able to tell you all about these in detail if you are interested.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with idiopathic painful small fiber neuropathy or sensory neuronopathy?
Are you able to attend study visits and provide regular pain ratings?
Are you generally in good health apart from your nerve condition?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive treatment through a drip (intravenous infusion) into your arm. You will receive either the study medicine (Privigen) or a saline solution (saltwater), which acts as a placebo. You will have several treatment periods, receiving both the active medicine and the placebo at different times, so we can see how each affects you. The saline solution is also given via a drip, using a common solution like Natriumklorid Fresenius Kabi. This helps us ensure that any observed effects are from the active medicine.

Your pain levels will be a key part of the assessment. You'll be asked to rate your pain regularly, especially during the second week after each infusion, and then across four weeks for a longer-term view. We'll also check how the treatment might affect your everyday activities and overall quality of life, using special questionnaires. We'll also take blood samples to look for specific markers related to your condition. We'll closely monitor you for any side effects throughout the study. The exact number of visits, duration of each infusion, and follow-up will be explained fully by the study team, but generally, this type of study involves regular contact and assessments over several weeks or months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might find that the study treatment helps to reduce your pain, which would be a positive outcome. You would also be contributing valuable information that could help others with similar conditions in the future. However, there's no guarantee the treatment will work for you, and you might experience side effects from the IVIG or even from the saline placebo (though this is less likely and often mild). Potential side effects of IVIG can include headaches, fever, chills, or allergic reactions, though serious reactions are rare. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is IVIG?

IVIG stands for intravenous immunoglobulins. It's a treatment made from blood plasma that contains important proteins (antibodies) from healthy donors, used to help people with certain immune system problems.

What is a 'placebo'?

A placebo is an inactive treatment, often a salt water solution, that looks exactly like the study medicine. It helps us compare the real effects of the medicine against what happens without any active drug.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know at the time. This is called 'blinding' and it's important so that your expectations don't affect the results. After the study, if suitable, your doctor might be told what you received.

What does 'pain intensity on a scale of 0 to 10' mean?

This is a simple way of measuring your pain. 0 means no pain at all, and 10 means the worst pain imaginable. You'll choose the number that best describes your pain.

How long will I be in the study?

The study's exact length can vary for each person, but typically involves several visits and assessments over a period of weeks or a few months. The study team will give you all the specific details.