Trial Outcomes & Findings for A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD) (NCT NCT03665038)
NCT ID: NCT03665038
Last Updated: 2025-09-15
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
28 participants
Primary outcome timeframe
From first dose of study drug up to end of follow-up period (up to Day 30)
Results posted on
2025-09-15
Participant Flow
Participants took part in the study at 8 investigating sites in the United States, from 07 September 2018 to 08 January 2021.
As per Protocol Versions 1 through 3, the study was initiated as a double-blind, placebo-controlled study, in which participants received brexanolone or brexanolone-matching placebo in a blinded manner. As per Protocol Version 4, the study was transitioned to an open-label study, where all participants received brexanolone.
Participant milestones
| Measure |
Double-Blind Phase: Placebo
Participants received a 60-hour single continuous intravenous (IV) infusion of brexanolone-matching placebo, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
12
|
|
Overall Study
COMPLETED
|
8
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Double-Blind Phase: Placebo
Participants received a 60-hour single continuous intravenous (IV) infusion of brexanolone-matching placebo, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
Baseline characteristics by cohort
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
n=12 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
16.6 years
STANDARD_DEVIATION 0.52 • n=5 Participants
|
16.4 years
STANDARD_DEVIATION 0.52 • n=7 Participants
|
16.3 years
STANDARD_DEVIATION 0.78 • n=5 Participants
|
16.4 years
STANDARD_DEVIATION 0.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to end of follow-up period (up to Day 30)Population: The safety set included all participants administered study drug.
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
n=12 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
4 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)Population: The pharmacokinetic (PK) set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=11 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Area Under the Concentration-Time Curve (AUC) From Time Zero to 60 Hours (AUC0-60)
|
3694.9 hours*nanograms per milliliter(hr*ng/mL)
Standard Deviation 397.90
|
3516.0 hours*nanograms per milliliter(hr*ng/mL)
Standard Deviation 562.85
|
—
|
SECONDARY outcome
Timeframe: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)Population: The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=11 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
AUC From Time Zero to Infinity (AUCinf)
|
4125.9 hr*ng/mL
Standard Deviation 481.84
|
3982.2 hr*ng/mL
Standard Deviation 709.70
|
—
|
SECONDARY outcome
Timeframe: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)Population: The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=11 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Maximum (Peak) Plasma Concentration (Cmax)
|
85.31 nanograms per milliliter (ng/mL)
Standard Deviation 9.571
|
81.66 nanograms per milliliter (ng/mL)
Standard Deviation 13.528
|
—
|
SECONDARY outcome
Timeframe: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)Population: The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=11 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Time at Maximum (Peak) Plasma Concentration (Tmax)
|
52.20 hour (hr)
Interval 52.0 to 52.4
|
52.30 hour (hr)
Interval 52.1 to 54.9
|
—
|
SECONDARY outcome
Timeframe: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)Population: The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.
Given that brexanolone is infused to steady-state plasma concentrations, the model-predicted steady-state drug concentration in the plasma during constant-rate infusion value also represents the predicted maximum plasma concentration at the highest infused dose (90 ug/kg/h).
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=11 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Steady-State Drug Concentration in the Plasma During Constant-Rate Infusion (Css)
|
79.4 ng/mL
|
79.4 ng/mL
|
—
|
SECONDARY outcome
Timeframe: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)Population: The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.
Cavg was evaluated as the time-weighted average plasma concentrations of brexanolone over the interval.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=11 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg)
|
61.59 ng/mL
Standard Deviation 6.639
|
58.60 ng/mL
Standard Deviation 9.386
|
—
|
SECONDARY outcome
Timeframe: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)Population: The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.
Half-life is the time required for half of the drug to be eliminated from the serum.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=11 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Half-Life of First Elimination Phase of Brexanolone (Thalf)
|
12.24 hour
Standard Deviation 0.466
|
12.55 hour
Standard Deviation 1.096
|
—
|
SECONDARY outcome
Timeframe: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)Population: The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.
Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=11 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Clearance of Brexanolone (CL/F)
|
66.86 liters per hour (L/hr)
Standard Deviation 13.858
|
77.88 liters per hour (L/hr)
Standard Deviation 18.026
|
—
|
SECONDARY outcome
Timeframe: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)Population: The PK set included participants in the safety set for whom at least one evaluable post-baseline PK sample with a measurable brexanolone concentration was available.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Outcome measures
| Measure |
Double-Blind Phase: Placebo
n=8 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=11 Participants
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Steady-State of Volume of Distribution (Vss)
|
448.1 liters (L)
Standard Deviation 70.34
|
588.5 liters (L)
Standard Deviation 187.53
|
—
|
Adverse Events
Double-Blind Phase: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Double-Blind Phase: Brexanolone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Open-Label Phase: Brexanolone
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind Phase: Placebo
n=8 participants at risk
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=8 participants at risk
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
n=12 participants at risk
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
8.3%
1/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
8.3%
1/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
Other adverse events
| Measure |
Double-Blind Phase: Placebo
n=8 participants at risk
Participants received a 60-hour single continuous IV infusion of brexanolone-matching placebo, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Double-Blind Phase: Brexanolone
n=8 participants at risk
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during double-blind phase of the study.
|
Open-Label Phase: Brexanolone
n=12 participants at risk
Participants received a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during open-label phase of the study.
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
16.7%
2/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
Nervous system disorders
Sedation
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
12.5%
1/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
8.3%
1/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
8.3%
1/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
8.3%
1/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
General disorders
Infusion site pain
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
25.0%
2/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
8.3%
1/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
General disorders
Infusion site extravasation
|
12.5%
1/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
General disorders
Infusion site inflammation
|
12.5%
1/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
General disorders
Infusion site swelling
|
12.5%
1/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
12.5%
1/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
8.3%
1/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
Infections and infestations
Localized infection
|
12.5%
1/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
12.5%
1/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
|
Investigations
Weight decreased
|
12.5%
1/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/8 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
0.00%
0/12 • From first dose of study drug up to end of follow-up period (up to Day 30)
The safety set included all participants administered study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
- Publication restrictions are in place
Restriction type: OTHER