Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brexanolone · 1 trial · 2 indications
The number and proportion of individuals experiencing any adverse event, any SAE, and any related adverse event overall will be summarized using frequency tables. No formal statistical tests will be conducted, rather the safety will be evaluated from a risk/benefit perspective. Any p-values reported will be for descriptive purposes only.
The change in heart rate a physiological safety/stress measure are continuous and obtained multiple times after study drug administration which occurs on day 1. This measure will be analyzed using descriptive statistics and graphical summaries including time-specific summary statistics (e.g., box and whisker plots).
The change in blood pressure a physiological safety/stress measure are continuous and obtained multiple times after study drug administration which occurs on day 2. This measure will be analyzed using descriptive statistics and graphical summaries including time-specific summary statistics (e.g., box and whisker plots).
The change in Cortisol a physiological safety/stress measure are continuous and obtained multiple times after study drug administration which occurs on day 2. This measure will be analyzed using descriptive statistics and graphical summaries including time-specific summary statistics (e.g., box and whisker plots).
A set of dose-response models will be tested response using the Multiple Comparisons Procedure Modifications (MCP-Mod) methodology including change in percentage of milliliters consumed during the 2-hour ad-libitum drinking paradigm within laboratory sessions (stress and neutral) as dependent variable, the treatment as factor (90, 60, 30 and 0 mcg/kg/h), and baseline dependent value. These dose-response models with repeated measures will be used to test the effects of the regimens of 90, 60, and 30 mcg/kg/h doses of brexanolone on alcohol consumption in self-administration.
Another set of dose-response models will test Multiple Comparisons Procedure Modifications (MCP-Mod) methodology for the 30-day follow-up in PCL-5 score as dependent variable, the treatment as factor (90, 60, 30 and 0 mcg/kg/h), and baseline dependent value. These dose-response models will be used to test the effects of the regimens of 90, 60, 30 and 0 mcg/kg/h doses of brexanolone on PTSD symptoms. Scale PCL-5 is 0-4 with 0 being not at all and 4 being extreme; the higher score is worse outcome
Another set of dose-response models will test Multiple Comparisons Procedure Modifications (MCP-Mod) methodology including change from intake to end of dosing in PCL-5 score as dependent variable, the treatment as factor (90, 60, 30 and 0 mcg/kg/h), and baseline dependent value. The same modeling will be repeated for the 30-day follow-up timepoint. These dose-response models will be used to test the effects of the regimens of 90, 60, 30 and 0 mcg/kg/h doses of brexanolone on PTSD symptoms. Scale PCL-5 is 0-4 with 0 being not at all and 4 being extreme; the higher score is worse outcome
| Arm | Type | Description |
|---|---|---|
| Placebo | NO_INTERVENTION | A 0.9% bag of sodium chloride will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking. |
| 90mcg/kg/h dose of Brexanolone | ACTIVE_COMPARATOR | Brexanolone will be diluted with sterile water and 0.9% sodium chloride and will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking. |
| 60mcg/kg/h dose of Brexanolone | ACTIVE_COMPARATOR | Brexanolone will be diluted with sterile water and 0.9% sodium chloride and will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking. |
| 30mcg/kg/h dose of Brexanolone | ACTIVE_COMPARATOR | Brexanolone will be diluted with sterile water and 0.9% sodium chloride and will be administered intravenously. Participant will be given a self-administered alcoholic drink of their choice that is individually calculated, and they will receive money up to $15 for every minute they resist drinking. |
| Name | Type | Description |
|---|---|---|
| Brexanolone | DRUG | The participant will receive either a placebo, or 90, 60, or 30 mcg/kg/hr of Brexanolone over a 20-hour period intravenous infusion. |
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged 21-70 years old, either active duty or with a history of US military service. 4. Current DSM-...
Brexanolone is an investigational small molecule being studied for Alcohol Use Disorder (AUD), specifically in patients with concurrent post-traumatic stress disorder (PTSD). It is being evaluated in a Phase 2 dose-finding study targeting stress-induced alcohol use in veterans. The drug is not yet approved for this indication.
Brexanolone is a small molecule that modulates the GABA-A receptor, a key target in the central nervous system involved in inhibitory neurotransmission. By acting on this receptor, it aims to address stress-induced alcohol use in patients with AUD and PTSD. This mechanism is being studied in a Phase 2 clinical trial.
Brexanolone is being developed by United Therapeutics Corporation, a biopharmaceutical company listed on NASDAQ under the ticker UTHR. The company is conducting a Phase 2 study of brexanolone for Alcohol Use Disorder and PTSD in veterans.
Brexanolone is in Phase 2 clinical development for Alcohol Use Disorder (AUD) with concurrent PTSD. It is currently being studied in a dose-finding trial that is not yet recruiting participants. The drug is investigational and has not been approved for this use.
Brexanolone is being studied in a Phase 2 clinical trial with the identifier NCT06580444. This randomized, double-blind, active-controlled study aims to evaluate brexanolone for targeting concurrent PTSD and stress-induced alcohol use in veterans. The trial plans to enroll 40 participants aged 21 years and older.
Brexanolone is the same drug as Zulresso, which is the brand name for brexanolone. Zulresso is approved for postpartum depression, while brexanolone is now being investigated for Alcohol Use Disorder and PTSD. The drug is being developed by United Therapeutics for this new indication.