A Randomized, double-blind, placebo-controlled, three-way cross-over study to assess the pharmacodynamic effects of an authorised and a new compound on nerve excitability threshold tracking in healthy male subjects.
This research study is for healthy men aged 18 and over. It's designed to understand how a new investigational medicine affects the way nerves send signals, compared to a medicine already approved for use and a placebo (a dummy pill with no medicine). The study wants to see if this new medicine could potentially help people who suffer from neuropathic pain, which is pain caused by nerve damage. By carefully studying how the medicines change nerve activity, researchers hope to learn more about how they work in the body. Participants will receive each of the three treatments at different times to help scientists compare their effects accurately.
At a glance
What is this study about?
Imagine your nerves are like tiny electrical wires sending messages all over your body. Sometimes, these wires can get damaged, causing a type of pain called neuropathic pain. This study is trying to find new ways to help people with this kind of pain.
Researchers are testing a new medicine to see how it affects these nerve messages. They will compare it to a medicine that's already approved for use and a placebo, which is a pill that looks the same but contains no medicine. The aim is to understand exactly how the new medicine works in the body, specifically how it changes the 'excitability' of your nerves – basically, how easily they send their signals.
This is a very early stage study, meaning it's one of the first times this new medicine is being tested in people. By carefully observing its effects in healthy volunteers, scientists can learn important information that might lead to a new treatment option for neuropathic pain in the future.
Key takeaways
- This study is testing a new medicine for potential nerve pain treatment.
- It involves healthy men aged 18 and over.
- Participants will try the new medicine, an existing medicine, and a dummy pill.
- The main aim is to understand how the new medicine affects nerve signals.
- It's an early-stage study to gather important information for future treatments.
Who may be eligible?
This study is specifically looking for healthy male volunteers. To be able to take part, you need to be at least 18 years old – there's no upper age limit, meaning older men can also join.
Because this is an early study, researchers carefully check everyone to make sure they are healthy and that taking part would be safe for them. You wouldn't be able to join if you have any serious health conditions or are taking certain medications.
The study is designed in a special way where all participants will try each of the three treatments (the new medicine, the approved medicine, and the dummy pill) at different times. This helps researchers compare the effects very clearly.
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 male?
- Are you 18 years old or older?
- Are you generally in good health?
- Are you willing to attend multiple clinic visits?
- Are you able to follow study instructions carefully?
What does participation involve?
If you decide to take part, you'll visit the study clinic several times. During these visits, the medical team will carry out health checks, like taking your blood pressure and heart rate, and collect some blood samples. You will be given one of the study treatments (either the new medicine, the approved medicine, or the dummy pill) and then undergo tests to measure how your nerves are responding. These tests are not painful and involve special equipment to track nerve signals.
Because it's a 'cross-over' study, you'll receive each of the three treatments over different periods, with 'wash-out' times in between. This means you'll have a break from any medication before starting the next one. This helps make sure that the effects of one treatment don't interfere with the next. The total duration of your participation, including all treatment periods and follow-up, will be explained in full detail by the study staff.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is 'nerve excitability'?
Nerve excitability refers to how easily your nerves can send electrical signals. This study is looking at how the medicines affect this process.
What is a 'placebo'?
A placebo is a 'dummy pill' that looks exactly like the real medicine but contains no active ingredients. It helps researchers understand the true effects of the study medicines.
Why are only men included in this study?
Early-stage studies sometimes focus on one sex to simplify the research and get a clearer picture of how a medicine works before expanding to a wider group.
Will I know which treatment I am receiving?
No, this is a 'double-blind' study, meaning neither you nor the study staff will know which treatment you are getting at any particular time. This helps ensure fair results.
What is 'neuropathic pain'?
Neuropathic pain is a type of long-lasting pain caused by damage to the nerves themselves, rather than due to an injury to tissues like muscles or bones.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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