A parallel-group treatment, proof-of-concept Phase 2, multicenter, double-blind, randomized 2 arm clinical trial to investigate the efficacy and safety of subcutaneous NT 201 injections compared with placebo injections in decreasing pain intensity in male and female participants aged 18 years and older with moderate or severe chronic neuropathic pain due to postherpetic neuralgia or peripheral nerve injury.
This research study is testing a new injectable medicine called NT 201 for people aged 18 and over who suffer from ongoing, moderate to severe nerve pain. This type of pain might be caused by shingles (postherpetic neuralgia) or other nerve injuries. We want to find out if NT 201 injections can help reduce pain better than a dummy injection (placebo), and if it's safe to use. You won't know if you're getting the actual medicine or the dummy injection, and neither will your study doctor. The study will mainly look at how your pain levels change over several weeks. It's a way for us to explore a new potential treatment for this difficult type of pain.
At a glance
What is this study about?
This study is about finding new ways to help people living with chronic neuropathic pain. This is a type of long-lasting pain that comes from damaged nerves. Specifically, we are focusing on nerve pain caused by shingles, also known as postherpetic neuralgia, or pain resulting from other nerve injuries. We know that this kind of pain can be very difficult to live with, and current treatments don't always work for everyone.
The main goal of this study is to test a new medicine called NT 201. This medicine is given as an injection under the skin. We want to see if these NT 201 injections can make your pain less intense compared to a 'dummy' injection (called a placebo), which contains no active medicine. It's really important to find out if NT 201 is effective and safe before it can be considered for wider use.
To make sure our results are fair and unbiased, some people in the study will receive the NT 201 injections, and others will receive the dummy injections. Neither you nor your study doctor will know which one you are getting. This helps us get clearer results about how well the new medicine works. We will be carefully monitoring your pain levels and any side effects over several weeks to understand the full impact of the treatment.
Key takeaways
- This study is testing a new injection (NT 201) for specific types of chronic nerve pain.
- It's for adults (18+) with moderate or severe nerve pain from shingles or nerve injury.
- The study compares NT 201 to a dummy injection (placebo) to see if it helps reduce pain and is safe.
- Neither you nor the doctor will know if you're getting the active medicine or the placebo.
- Participation involves regular clinic visits, injections, and pain assessments over several weeks.
- You can stop participating at any time.
Who may be eligible?
This study is looking for both men and women aged 18 or older.
To be considered for this study, you must have ongoing moderate to severe nerve pain. This pain needs to be specifically caused by either shingles (postherpetic neuralgia) or an injury to a peripheral nerve (nerves outside of your brain and spinal cord).
There will also be other specific health requirements and medical checks to make sure the study is right for you and safe for everyone involved. Your study doctor or nurse will discuss all of these with you in detail.
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?
- Do you have ongoing nerve pain that is moderate or severe?
- Is your nerve pain caused by previous shingles (postherpetic neuralgia) or a documented nerve injury?
- Are you comfortable with receiving regular injections under the skin?
- Are you willing and able to attend all required study appointments?
- Have you discussed your current medications and health conditions with the study team?
What does participation involve?
If you join this study, it will involve several visits to a clinic over a period of weeks. You will receive regular injections under the skin, either of the study medicine (NT 201) or a dummy injection (placebo). You will have various tests and assessments, including answering questions about your pain and general health. You might also have blood tests. We will keep a close eye on any side effects you might experience. The total duration of your participation, including follow-up, will be determined by the study plan, but the main pain assessments will take place between weeks 2 and 12.
Potential risks and benefits
Locations (6)
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What is 'nerve pain'?
Nerve pain, or neuropathic pain, is a type of ongoing pain caused by damage to your nerves. It can feel like burning, shooting, or prickling sensations.
What is 'postherpetic neuralgia'?
This is a complication of shingles, where nerve pain continues in the area affected by the shingles rash, even after the rash has healed.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active ingredients. It helps us fairly compare the real medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, you and your study doctor will not know. This is called 'double-blind' and helps ensure the study results are as accurate as possible.
Can I take my usual pain relief during the study?
The study mentions 'Paracetamol' as a possible intervention. Your study doctor will provide clear guidance on what pain relief, if any, you can take during the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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