A phase I, randomized, double-blind, placebo-controlled, two-way cross-over, multiple dose study to evaluate the pharmacodynamic effects of TRV045 on the cortical excitability in healthy male adults
This is an early-stage medical study, often called a Phase 1 trial. Researchers are investigating a new medication, TRV045, which they hope might help people with epilepsy. Instead of testing it on people with epilepsy straight away, this particular study is focused on healthy adult men aged 18 and over. The main goal is to understand how TRV045 affects brain activity. Participants will take either TRV045 or a placebo (a dummy pill with no active drug) during different periods of the study. This helps researchers compare the effects of the drug to no treatment, giving them important information before testing it in patients. This kind of study is crucial for learning about new drugs and their potential safely.
At a glance
What is this study about?
This study is an early step in developing a new medicine, TRV045, for a condition called epilepsy. Epilepsy affects the brain and can cause seizures. Before a new medicine can be given to people with a condition, doctors need to understand how it works and whether it's safe. That's what this study aims to do.
In this particular study, researchers are looking at how TRV045 changes the electrical activity in the brains of healthy men. They're using a special test to measure something called 'cortical excitability,' which is a way of seeing how easily brain cells get excited. By comparing what happens when someone takes TRV045 to when they take a placebo (a dummy pill with no active ingredient), scientists can learn if the drug has an effect on brain activity and how strong that effect might be.
This kind of research is really important because it helps scientists decide if TRV045 should be moved on to bigger studies involving people who actually have epilepsy. It's a careful and step-by-step process to make sure new medicines are safe and have a good chance of being effective.
Key takeaways
- This is an early-stage study for a new epilepsy drug (TRV045).
- It's testing how the drug affects brain activity in healthy men.
- Participants will receive both the active drug and a dummy pill at different times.
- The main goal is to check safety and how the drug works, not to treat epilepsy.
- Participation helps future development of epilepsy treatments.
- You can withdraw from the study at any point.
Who may be eligible?
This study is looking for healthy men aged 18 years and older to take part. There isn't an upper age limit mentioned, so if you're a man and over 18, you might be able to join.
To be considered for this study, you need to be in good general health. This means you don't have any major ongoing health problems or illnesses that could affect the results of the study or put you at risk.
The research team will carry out several checks and tests to make sure you meet all the specific health requirements before you can be included in the study. This is to ensure your safety throughout the trial.
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 healthy with no serious ongoing medical conditions?
- Are you willing to attend multiple clinic visits?
- Are you comfortable with the idea of taking a study drug and a placebo?
- Are you interested in contributing to medical research for epilepsy?
What does participation involve?
If you decide to take part in this study, you will likely have several visits to a clinic or research center. During these visits, you’ll be given either the study drug (TRV045) or a placebo, which looks exactly like the real drug but contains no active medicine. You won't know which one you're taking at any given time, and neither will the study team – this is called 'double-blind'.
You'll be asked to take the medication for specific periods, followed by breaks. Because it’s a 'cross-over' study, you will get both the active drug and the placebo at different times, which helps compare their effects in the same person. Throughout the study, special tests will be done to measure your brain activity, such as tests that check how your brain reacts to certain signals. These assessments might involve short procedures and will help the researchers understand how the drug is working. There will also be follow-up appointments to monitor your health after you've finished taking the medication. The total time you'll be involved in the study will be explained in detail by the research team.
Potential risks and benefits
Locations (1)
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Common questions
What is a Phase 1 study?
Phase 1 studies are the first stage of testing a new drug in humans. They mainly check if the drug is safe and how it behaves in the body, often using healthy volunteers.
What is a placebo?
A placebo is a 'dummy' pill or treatment that looks exactly like the real medication but doesn't contain any active drug. It helps researchers compare the real drug's effects.
Why are only men being studied?
Sometimes, early studies focus on one sex to simplify the research and understand the basic effects of a drug before seeing if there are differences in how it affects men and women.
What does 'cortical excitability' mean?
It refers to how easily the cells in the outer layer of your brain (the cortex) can be stimulated. Researchers are looking to see if the drug changes this brain activity.
Will I know if I'm taking the drug or the placebo?
No, in this 'double-blind' study, neither you nor the research team will know who is getting the active drug and who is getting the placebo until after the study is over. This helps keep the results unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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