Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Effects of promethazine and altered gravity on bimanual coordination

This research is investigating how a medicine called promethazine (also known as Phenergan, often used for allergies, sickness, or as a calming aid) and different gravity conditions might influence how effectively people use both hands at the same time. This is important for understanding coordination in daily life and in specific situations, like space travel. We're inviting healthy adult volunteers to take part. Participants will receive either promethazine or a dummy pill (placebo) and their coordination will be carefully measured. The study aims to gather more information on a medicine already in use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Novespace

Enrolment target

Start

02 Jun 2023

Healthy volunteers

What is this study about?

This study is exploring something called 'bimanual coordination.' This simply means how well you can use both of your hands together to do a task, like tying shoelaces or playing an instrument. We want to see how this coordination might be affected by a medicine called promethazine, which you might know as Phenergan. This medicine is often used to treat allergies, sickness, or to help people feel calmer.

We're also looking at how changes in 'gravity' might play a role. While you won't actually be going into space, researchers have ways to safely simulate some effects of altered gravity here on Earth. Understanding how these factors – the medicine and gravity changes – impact coordination is really important. It can help us learn more about how our bodies work, not just in everyday life, but also in special situations, like for astronauts or people in environments where gravity might feel different.

Because promethazine is a medicine that's already been used for a long time, this study, called a Phase IV trial, aims to gather even more detailed information about its effects, especially in these specific conditions. By taking part, you'd be helping scientists gain valuable insights that could benefit many people.

Key takeaways

The study explores how promethazine and changes in gravity affect using both hands.
It's open to healthy adults aged 18 and over, both men and women.
Participants will receive either promethazine or a dummy pill.
Coordination will be measured through specific tasks and tests.
It's a Phase IV study, gathering more information on an existing medicine.
Your involvement helps improve understanding of how our bodies work.

Who may be eligible?

To take part in this study, you need to be a healthy adult. This means you generally don't have any major ongoing health problems that could affect the results of the study or make it unsafe for you.

Anyone aged 18 years or older is welcome to consider joining. There is no upper age limit, meaning older adults can also participate if they are healthy enough.

Both men and women are invited to take part in this research. The study aims to include a wide range of healthy individuals to get the most complete picture.

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 consider yourself generally healthy?
Are you comfortable potentially taking a study medicine or a dummy pill?
Are you able to attend study appointments as required?
Are you willing to have your hand coordination measured?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your involvement would include several steps. You would be given either the study medicine, promethazine, or a dummy pill (placebo) which looks the same but has no active ingredients. You won't know which one you're receiving, and neither will the study team, until after the study is complete. You would attend appointments where your ability to use both hands together (bimanual coordination) would be measured using specific tests. These tests might involve tasks that assess your rhythm and timing when using both hands. The total duration of your participation, including all visits and follow-up, would be fully explained to you before you agree to take part.

Potential risks and benefits

Taking part in a study like this helps advance medical understanding, which could benefit others in the future. You might also receive careful health monitoring during your participation. However, there are potential risks, such as side effects from the medicine (promethazine can cause drowsiness, dizziness, or dry mouth) or discomfort from the tests. You will be given full information about all known risks. Remember, your participation is completely voluntary; you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
France

Common questions

What is 'bimanual coordination'?

It's simply how well you can use both of your hands together at the same time to do a task, like clapping or using cutlery.

What is promethazine?

It's a common medicine, sometimes known as Phenergan, often used for allergies, to stop sickness, or to help you feel calm.

Will I go into space for the 'altered gravity' part?

No, you won't. Researchers have safe ways to simulate some effects of altered gravity here on Earth for the study.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers compare effects.

Do I have to be sick to join?

No, quite the opposite! This study is specifically looking for healthy volunteers, meaning people who don't have existing major health problems.