Trial Outcomes & Findings for An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus (NCT NCT05645432)
NCT ID: NCT05645432
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 after the start of brexanolone, or any worsening of a pre-existing medical condition/adverse event with onset after the start of brexanolone and throughout the study.
COMPLETED
PHASE2
10 participants
Up to Day 15
2025-09-15
Participant Flow
Participants were enrolled at one active clinical site in the United States from 10 May 2023 to 21 November 2023.
A total of 29 participants were screened, of which 10 were enrolled and treated.
Participant milestones
| Measure |
Brexanolone
Participants received a 6-hour single continuous intravenous (IV) infusion of brexanolone at 30 micrograms per kilogram per hour (mcg/kg/hour) for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
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|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Brexanolone
Participants received a 6-hour single continuous intravenous (IV) infusion of brexanolone at 30 micrograms per kilogram per hour (mcg/kg/hour) for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
Baseline characteristics by cohort
| Measure |
Brexanolone
n=10 Participants
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
|
|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 15Population: Safety set included all participants who received any amount of brexanolone.
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 after the start of brexanolone, or any worsening of a pre-existing medical condition/adverse event with onset after the start of brexanolone and throughout the study.
Outcome measures
| Measure |
Brexanolone
n=10 Participants
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
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|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1Population: Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation.
VAS-L is a subject-rated scale used to assess the perceived loudness of tinnitus. Participants answered the question "How loud is your tinnitus now?" on a horizontal scale anchored on left by "not audible" (score of 0) and on right by "extremely loud" (score of 100). Higher scores represent greater severity. Negative change from baseline represents better outcome of the treatment. For the treatment period (Day 1), baseline was defined as the most recent value immediately prior to the start of brexanolone infusion, or predose.
Outcome measures
| Measure |
Brexanolone
n=10 Participants
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
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|---|---|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings
Change at Day 1, Hour 0.5
|
-3.1 score on a scale
Standard Deviation 8.33
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings
Change at Day 1, Hour 1
|
-8.1 score on a scale
Standard Deviation 14.13
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings
Change at Day 1, Hour 2
|
-7.2 score on a scale
Standard Deviation 14.41
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings
Change at Day 1, Hour 3
|
-11.2 score on a scale
Standard Deviation 14.54
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings
Change at Day 1, Hour 4
|
-15.4 score on a scale
Standard Deviation 16.26
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings
Change at Day 1, Hour 5
|
-15.7 score on a scale
Standard Deviation 15.72
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings
Change at Day 1, Hour 6
|
-12.8 score on a scale
Standard Deviation 9.32
|
SECONDARY outcome
Timeframe: Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1Population: Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation.
VAS-L is a subject-rated scale used to assess the perceived loudness of tinnitus. Participants answered the question "How loud is your tinnitus now?" on a horizontal scale anchored on left by "not audible" (score of 0) and on right by "extremely loud" (score of 100). Higher scores represent greater severity. Negative change from baseline represents better outcome of the treatment. A Mixed Model Repeated Measures (MMRM) with fixed effects for baseline VAS component value and change from baseline scores as the dependent variable is used. For the treatment period (Day 1), baseline was defined as the most recent value immediately prior to the start of brexanolone infusion, or predose.
Outcome measures
| Measure |
Brexanolone
n=10 Participants
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
|
|---|---|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings
Change at Day 1, Hour 0.5
|
-3.10 score on a scale
Standard Error 2.486
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings
Change at Day 1, Hour 1
|
-8.10 score on a scale
Standard Error 4.441
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings
Change at Day 1, Hour 2
|
-7.20 score on a scale
Standard Error 4.472
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings
Change at Day 1, Hour 3
|
-11.20 score on a scale
Standard Error 4.474
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings
Change at Day 1, Hour 4
|
-15.40 score on a scale
Standard Error 5.043
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings
Change at Day 1, Hour 5
|
-15.70 score on a scale
Standard Error 4.826
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings
Change at Day 1, Hour 6
|
-12.80 score on a scale
Standard Error 3.013
|
SECONDARY outcome
Timeframe: Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1Population: Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation.
VAS-A is a subject-rated scale used to assess the tinnitus. Participants answered the question "How much is your tinnitus annoying you now?" on a horizontal scale anchored on the left by "not annoying" (score of 0) and on the right by "extremely annoying" (score of 100). Higher scores represent greater severity. Negative change from baseline represents better outcome of the treatment. For the treatment period (Day 1), baseline was defined as the most recent value immediately prior to the start of brexanolone infusion, or predose.
Outcome measures
| Measure |
Brexanolone
n=10 Participants
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
|
|---|---|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings
Change at Day 1, Hour 0.5
|
-7.6 score on a scale
Standard Deviation 13.45
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings
Change at Day 1, Hour 1
|
-9.8 score on a scale
Standard Deviation 18.74
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings
Change at Day 1, Hour 2
|
-16.6 score on a scale
Standard Deviation 28.68
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings
Change at Day 1, Hour 3
|
-16.9 score on a scale
Standard Deviation 20.00
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings
Change at Day 1, Hour 4
|
-21.3 score on a scale
Standard Deviation 28.07
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings
Change at Day 1, Hour 5
|
-22.0 score on a scale
Standard Deviation 27.71
|
|
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings
Change at Day 1, Hour 6
|
-22.3 score on a scale
Standard Deviation 20.92
|
SECONDARY outcome
Timeframe: Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1Population: Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation.
VAS-A is a subject-rated scale used to assess the tinnitus. Participants answered the question "How much is your tinnitus annoying you now?" on a horizontal scale anchored on the left by "not annoying" (score of 0) and on the right by "extremely annoying" (score of 100). Higher scores represent greater severity. Negative change from baseline represents better outcome of the treatment. A MMRM with fixed effects for baseline VAS component value and change from baseline scores as the dependent variable is used. For the treatment period (Day 1), baseline was defined as the most recent value immediately prior to the start of brexanolone infusion, or predose.
Outcome measures
| Measure |
Brexanolone
n=10 Participants
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
|
|---|---|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings
Change at Day 1, Hour 0.5
|
-7.60 score on a scale
Standard Error 4.088
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings
Change at Day 1, Hour 1
|
-9.80 score on a scale
Standard Error 5.193
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings
Change at Day 1, Hour 2
|
-16.60 score on a scale
Standard Error 8.108
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings
Change at Day 1, Hour 3
|
-16.90 score on a scale
Standard Error 5.790
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings
Change at Day 1, Hour 4
|
-21.30 score on a scale
Standard Error 7.980
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings
Change at Day 1, Hour 5
|
-22.00 score on a scale
Standard Error 7.882
|
|
Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings
Change at Day 1, Hour 6
|
-22.30 score on a scale
Standard Error 5.167
|
SECONDARY outcome
Timeframe: Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1Population: Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation.
VAS-L is subject-rated scale used to assess perceived loudness of tinnitus. Participants answered question "How loud is your tinnitus now?" on horizontal scale anchored on left by "not audible" (score of 0) and on right by "extremely loud" (score of 100) via daily diary over multiple days. Higher scores= greater severity. Negative change from baseline= better outcome of treatment. For remote assessments (Day 2 through 7), ratings were obtained twice daily (morning and evening). Daily arithmetic mean was calculated by averaging morning and evening scores. If a participant was missing either a morning or evening score, then single available score was used as the mean for that day. Baseline is defined as the average value of Day -7 to Day -1 measurements. This was calculated by summing daily arithmetic means and dividing by total number of non-missing days.
Outcome measures
| Measure |
Brexanolone
n=10 Participants
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
|
|---|---|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 2
|
-17.56 score on a scale
Standard Deviation 19.125
|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 3
|
-17.51 score on a scale
Standard Deviation 22.231
|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 4
|
-15.61 score on a scale
Standard Deviation 20.084
|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 5
|
-16.76 score on a scale
Standard Deviation 22.388
|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 6
|
-16.96 score on a scale
Standard Deviation 22.235
|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 7
|
-11.31 score on a scale
Standard Deviation 19.509
|
SECONDARY outcome
Timeframe: Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1Population: Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation.
VAS-L is subject-rated scale used to assess perceived loudness of tinnitus. Participants answered question "How loud is your tinnitus now?" on horizontal scale anchored on left by "not audible" (score of 0) and on right by "extremely loud" (score of 100) via daily diary over multiple days. Higher scores= greater severity. Negative change from baseline= better outcome of treatment. For remote assessments (Day 2 through 7), ratings were obtained twice daily (morning and evening). Daily arithmetic mean was calculated by averaging morning and evening scores. If a participant was missing either a morning or evening score, then single available score was used as the mean for that day. A MMRM with fixed effects for baseline VAS component value and change from baseline scores as the dependent variable is used. Baseline is defined as the average value of Day -7 to Day -1 measurements. This was calculated by summing daily arithmetic means and dividing by total number of non-missing days.
Outcome measures
| Measure |
Brexanolone
n=10 Participants
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
|
|---|---|
|
Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 2
|
-17.56 score on a scale
Standard Error 6.769
|
|
Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 3
|
-17.51 score on a scale
Standard Error 8.035
|
|
Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 4
|
-15.61 score on a scale
Standard Error 6.805
|
|
Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 5
|
-16.76 score on a scale
Standard Error 8.064
|
|
Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 6
|
-16.96 score on a scale
Standard Error 7.721
|
|
Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 7
|
-11.31 score on a scale
Standard Error 7.330
|
SECONDARY outcome
Timeframe: Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1Population: Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation.
VAS-A is subject-rated scale used to assess the tinnitus. Participants answered the question "How much is your tinnitus annoying you now?" on horizontal scale anchored on left by "not annoying" (score of 0) and on right by "extremely annoying" (score of 100) via daily diary over multiple days. Higher scores=greater severity. Negative change from baseline=better outcome of treatment. For remote assessments (Day 2 through 7), ratings were obtained twice daily (morning and evening). Daily arithmetic mean was calculated by averaging morning and evening scores. If a participant was missing either a morning or evening score, then single available score was used as the mean for that day. Baseline is defined as the average value of Day -7 to Day -1 measurements. This was calculated by summing daily arithmetic means and dividing by total number of non-missing days.
Outcome measures
| Measure |
Brexanolone
n=10 Participants
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
|
|---|---|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 2
|
-19.41 score on a scale
Standard Deviation 19.492
|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 3
|
-16.01 score on a scale
Standard Deviation 21.161
|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 4
|
-13.41 score on a scale
Standard Deviation 23.037
|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 5
|
-15.16 score on a scale
Standard Deviation 26.075
|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 6
|
-11.51 score on a scale
Standard Deviation 27.493
|
|
Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 7
|
-7.61 score on a scale
Standard Deviation 23.659
|
SECONDARY outcome
Timeframe: Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1Population: Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation.
VAS-A is subject-rated scale used to assess the tinnitus. Participants answered the question "How much is your tinnitus annoying you now?" on horizontal scale anchored on left by "not annoying" (score of 0) and on right by "extremely annoying" (score of 100) via daily diary over multiple days. Higher scores=greater severity. Negative change from baseline=better outcome of treatment. For remote assessments (Day 2 through 7), ratings were obtained twice daily (morning and evening). Daily arithmetic mean was calculated by averaging morning and evening scores. If a participant was missing either a morning or evening score, then single available score was used as the mean for that day. A MMRM with fixed effects for baseline VAS component value and change from baseline scores as the dependent variable is used. Baseline is defined as the average value of Day -7 to Day -1 measurements. This was calculated by summing daily arithmetic means and dividing by total number of non-missing days.
Outcome measures
| Measure |
Brexanolone
n=10 Participants
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
|
|---|---|
|
Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 2
|
-19.41 score on a scale
Standard Error 7.266
|
|
Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 3
|
-16.01 score on a scale
Standard Error 8.111
|
|
Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 4
|
-13.41 score on a scale
Standard Error 8.288
|
|
Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 5
|
-15.16 score on a scale
Standard Error 8.716
|
|
Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 6
|
-11.51 score on a scale
Standard Error 9.523
|
|
Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days
Change at Day 7
|
-7.61 score on a scale
Standard Error 8.078
|
Adverse Events
Brexanolone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brexanolone
n=10 participants at risk
Participants received a 6-hour single continuous IV infusion of brexanolone at 30 mcg/kg/hour for 0 to 0.5 hours, at 60 mcg/kg/hour for 0.5 to 1 hour, and at 90 mcg/kg/hour for 1 to 6 hours, on Day 1 of the Treatment Period.
|
|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • Up to Day 15
Safety set included all participants who received any amount of brexanolone.
|
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