Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

The sedative effects and local tolerability of nasal administration of remimazolam using a Soft Mist Nasal Administration Device

This research is investigating a nasal spray delivery method for a medicine called Byfavo, which is usually given by injection. The study wants to understand how effectively this nose spray helps people feel more relaxed and sleepy, especially if they are experiencing stress or anxiety. Researchers will also check if the spray is easy and comfortable to use, and if there are any side effects. The goal is to explore if this new way of taking the medicine could be a good option for people who need to feel calmer quickly, without having to have an injection.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Stichting Radboud universitair medisch centrum

Enrolment target

Start

22 Jan 2025

stress anxiety anxiety

What is this study about?

Imagine you're feeling really stressed or anxious, and you need something to help you calm down quickly. This study is looking at a new way to give a medicine called Byfavo, which is usually given through a drip or injection. Instead, they're trying a special nose spray that creates a fine mist. The main idea is to see if this nose spray can make you feel sleepy and relaxed, offering a gentler and quicker option than an injection.

The researchers will be carefully observing how your body reacts to the nose spray. They'll measure things like how sleepy you become and how quickly. They'll also ask you how you feel, for example, if you feel more relaxed or if it's comfortable to use the spray. This information will help them understand if this nose spray could be a helpful option for people dealing with stress or anxiety.

This is an early stage of testing, called Phase II. It means the researchers are exploring if the medicine works in this new way and if it's safe and well-tolerated. If it proves to be promising, it could eventually lead to a new treatment option that is less invasive and easier to use for people who need to calm down quickly.

Key takeaways

Tests a new nose spray for stress and anxiety.
Uses Byfavo, a medicine that helps calm you.
Aims to see how sleepy and relaxed you feel.
Investigates if the spray is comfortable to use.
For adults aged 18 and over.

Who may be eligible?

This study is open to adults aged 18 and older. Both men and women can take part.

To be considered for the study, you'll need to go through a screening process. This is to make sure the study is a good fit for you and that taking part would be safe based on your overall health.

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 feel stressed or anxious sometimes?
Are you comfortable trying a new nose spray medication?
Are you able to attend appointments for observation?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the study medicine, Byfavo, as a nose spray. There will be several measurements taken, such as how sleepy you are and how you feel, both before and at set times after taking the spray (at 5, 10, 15, 20, 30, 40, 50, 60, 90, and 180 minutes). You'll also be asked to complete some questionnaires to describe your feelings of alertness, relaxation, and any effects you notice from the spray. The precise number of visits and the total duration would be explained in more detail by the study team, but generally, studies like this involve a few visits or a single longer visit for the observation period.

Potential risks and benefits

Participating in this study might offer the benefit of gaining early access to a potential new way to manage stress and anxiety, and you'll contribute to medical knowledge that could help others. However, like any medicine, the nose spray could have side effects, and it's possible you might not experience any benefits. 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
Netherlands

Common questions

What is Byfavo?

Byfavo is a medicine that helps people feel calm and sleepy. In this study, it's being tested as a nose spray.

Why is this study important?

This study is looking for a new, potentially easier way to help people who are feeling stressed or anxious, without needing an injection.

What will I have to do if I join?

You'll be given the nose spray and researchers will take measurements and ask you questions about how you feel over a few hours.

Are there any risks?

Like all medicines, there could be side effects. The study team will explain these fully to you before you decide to take part.

Can I stop participating at any time?

Yes, you are free to leave the study at any point without it affecting your medical care.