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Transcranial Magnetic Stimulation (TMS) Evaluation of Central Nervous System (CNS) Pharmacodynamic (PD) Activity of Brexanolone in Healthy Male Participants
EU CTIS ID: 2022-503019-40-00
What this study is testing
To evaluate the CNS PD response to brexanolone using TMS-induced MEPs compared to the responses of placebo and lorazepam.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant is a healthy ambulatory male adult and has no clinically significant findings, as determined by the investigator, on physical examination, including neurologic and mental status examinations, 12-lead electrocardiogram (ECG), or laboratory tests.
- Participant is ≥18 and ≤65 years of age at the time informed consent is obtained.
- Participant has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤33.0 kg/m2 at screening.
You likely can't join if
- Participant has a significant history or presence of psychiatric or neurologic disease or condition (including, but not limited to, epilepsy, closed head trauma with clinically significant sequelae, partial onset seizures, eating disorders, etc.).
- Participant has a history of intracranial mass lesion, hydrocephalus, and/or clinically significant head injury or trauma that could increase the risk of applying TMS.
- Participant has metal objects in the brain or skull or has a cochlear implant/deep brain stimulation device.
- Participant currently takes any psychotropic medications, including antidepressants and anxiolytics.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.