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Study to evaluate the effects of brexanolone and lorazepam on the nervous system in healthy male participants using magnetic brain stimulation

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Centre for Human Drug Research Leiden The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
06.05.2023

Trial locations

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.

The provided source data indicates that the study is being conducted in healthy volunteers and does not list a specific disease or medical condition. Therefore, no disease descriptions can be provided.

Trial ID:
2022-503019-40-00
Protocol code:
547-TRM-101
Trial Phase:
Human Pharmacology (Phase I) – Other

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