Study to evaluate the effects of brexanolone and lorazepam on the nervous system in healthy male participants using magnetic brain stimulation
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This study aims to evaluate the effects of brexanolone on the central nervous system, which is the complex network of nerves in the brain and spinal cord. The research compares how this substance affects brain activity compared to lorazepam and a placebo. The investigation uses transcranial magnetic stimulation, a method that uses magnetic fields to stimulate nerve cells in the brain, to observe changes in how the nervous system functions.
Participants will take part in a study involving four different periods where they will receive different treatments in a specific order. During these periods, the administration of brexanolone is given through intravenous means, which means the medicine is delivered directly into a vein. The lorazepam is taken as an oral tablet. By using a crossover design, each person receives each treatment at different times to allow for a direct comparison of the effects.
The research process
The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- You must be a healthy adult male who is able to walk on your own, which is known as being ambulatory.
- A doctor must find no significant health issues during your physical exam, which includes checking your neurologic status (how your brain and nerves work) and your mental status (your ability to think and respond clearly).
- You must have a normal 12-lead electrocardiogram (ECG), which is a test that records the electrical activity of your heart.
- Your laboratory tests, such as blood or urine tests, must show no significant health concerns.
- You must be between 18 and 65 years old at the time you agree to join the study.
- Your body weight must be at least 50 kg (about 110 pounds).
- Your body mass index (BMI), which is a calculation used to check if your weight is healthy for your height, must be between 18.0 and 33.0.
Who cannot join the trial?
6 criteria
- You have a history or current condition involving psychiatric disorders (mental health conditions) or neurologic diseases (conditions affecting the brain or nervous system), such as epilepsy (a disorder causing seizures), eating disorders, or seizures.
- You have experienced a closed head trauma, which means a head injury where the skull was not broken, that resulted in lasting health problems or sequelae (the long-term effects or consequences of a medical condition).
- You have a history of an intracranial mass lesion (a growth or tumor inside the skull), hydrocephalus (a buildup of fluid in the brain), or any serious head injury that could make using TMS (a medical technique that uses magnetic fields to stimulate the brain) unsafe.
- You have any metal objects located inside your brain or skull.
- You have a cochlear implant (a device used to help with hearing) or a deep brain stimulation device (an implanted device used to treat certain brain disorders).
- You are currently taking any psychotropic medications, which are drugs used to affect the mind, including antidepressants (medicine used to treat depression) or anxiolytics (medicine used to reduce anxiety).
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
Brexanolone
is a medication given through an IV (intravenous) line to study its effects on the central nervous system.
Lorazepam
is a medication taken by mouth used in this study to compare its effects on the central nervous system against the other treatments.
What is already known about the treatment
Lorazepam
This medication is taken as a pill that is swallowed by mouth. It is a well-established drug used to treat conditions like anxiety and sleep problems. It works by increasing the activity of a natural chemical in the brain that helps calm the nervous system, making it a type of sedative.
Brexanolone
This substance is administered through an intravenous drip, meaning it is delivered directly into a vein. It is currently being studied for its effects on the brain and is primarily used to treat certain types of severe depression. At a molecular level, it mimics a natural hormone in the brain to help balance nerve cell activity, classifying it as a neuroactive compound.
Investigated diseases
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?