Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Randomized, Double-blind, Double Placebo-controlled, 4-Period Crossover Study to Evaluate the Central Nervous System Pharmacodynamic Activity of Brexanolone Using Transcranial Magnetic Stimulation in Healthy Male Participants

This research study is investigating the effects of a new medicine called brexanolone on the brain's activity in healthy male volunteers. To do this, we're using a special, non-invasive brain scanning technique called Transcranial Magnetic Stimulation (TMS). TMS allows us to gently stimulate the brain and measure how nerve cells respond. Participants in the study will receive brexanolone, a common calming medicine called lorazepam, and placebo (dummy) pills over different periods. This allows us to compare the effects of brexanolone directly. Our main goal is to understand how brexanolone changes brain signals, which could help us learn more about how it works and if it might be helpful for certain brain conditions in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sage Therapeutics Inc.

Enrolment target

Start

28 Apr 2023

PD study in Healthy Volunteers

What is this study about?

This research study, called a clinical trial, is designed for healthy men to help us understand how a new medicine called brexanolone affects the brain. We use a special, gentle brain scanning method called Transcranial Magnetic Stimulation (TMS). TMS creates a magnetic field near the head that can briefly and painlessly stimulate specific parts of the brain. By doing this, we can measure how the brain's nerve cells respond.

The main aim of this study is to see how brexanolone changes these brain signals compared to a well-known calming medicine called lorazepam, and also compared to a "dummy" pill (placebo) that has no active medicine. Participants will take each of these over different periods, which helps us to get a very clear picture of brexanolone's specific effects. We're interested in how the medicine affects the strength of signals sent by brain cells.

Understanding how brexanolone affects brain activity in healthy people is an important first step. This kind of early research, often called human pharmacology or Phase I, helps scientists learn more about how a new medicine works in the body and brain. This knowledge can then be used to help design future studies for people with specific health conditions, to see if the medicine could be a safe and effective treatment for them.

Key takeaways

A study for healthy men aged 18 and over.
Investigates a new medicine, brexanolone, and its effects on brain activity.
Uses safe, non-invasive TMS brain scans.
Compares brexanolone to a calming medicine and dummy pills.
Aims to understand how brexanolone works in the brain.
Participation is voluntary, and your safety is a priority.

Who may be eligible?

This study is specifically looking for healthy male volunteers. To be considered, you need to be at least 18 years old. There isn't an upper age limit mentioned, so older men might also be able to take part if they meet other health criteria.

Being 'healthy' means you shouldn't have any major ongoing medical conditions or take regular medications that could interfere with the study medicines or the TMS brain scans. The research team will do a thorough health check to make sure it's safe for you to participate.

Before you decide, the study team will go through all the requirements with you in detail. This ensures that the study is right for you and that your participation will be safe and provide useful information for the research.

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 a man?
Are you 18 years old or older?
Are you generally healthy, without major ongoing medical conditions?
Are you *not* currently taking regular medicines that could interfere with study drugs (this will be checked by the team)?
Are you comfortable having regular health checks and brain scans?
Are you able to attend multiple study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will go through several stages. You will visit the study clinic multiple times. During these visits, you will receive different treatments: brexanolone (the new medicine), lorazepam (a common calming medicine), and placebo (dummy pills).

Because this is a 'crossover' study, you will try each of these treatments at different times, with breaks in between. Neither you nor the study team will know which treatment you are receiving at any given time – this is called 'double-blind' and helps ensure the results are unbiased. At each stage, you will have TMS brain scans to measure your brain activity. There will also be other health checks and observations to see how you are responding. The total duration of your participation, including all visits and follow-up, will be explained by the study team, likely spanning several weeks or months.

Potential risks and benefits

Taking part in any research study involves potential benefits and risks. For this study, potential benefits include receiving careful medical attention and contributing valuable information that could help develop new treatments in the future. As for risks, TMS is generally considered safe, but some people might experience mild discomfort, headache, or temporary changes in sensation. The medicines, brexanolone and lorazepam, can cause side effects like drowsiness or dizziness. All possible risks will be fully explained to you before you agree to participate, and your safety will be closely monitored. Remember, you can choose 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 TMS?

TMS, or Transcranial Magnetic Stimulation, is a way to gently stimulate parts of the brain using a magnetic field near your head. It helps us see how brain cells are working.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps us compare the true effects of the medicine.

Why are only men included?

Sometimes, early studies focus on one sex to understand how a medicine works without potential differences in how men and women's bodies process it. Future studies might include women.

Will I know which medicine I'm getting?

No, neither you nor the doctors will know which medicine you're taking at any given time. This is called 'double-blind' and helps keep the study fair and unbiased.

Do I have to take part?

No, taking part is completely voluntary. You can decide not to participate, or withdraw at any time, without it affecting your medical care in any way.