Trial · NCT05645432
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
NCT05645432, Phase 2, Completed, Supernus Pharmaceuticals, Inc.; results first posted 2024-12-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus. Trials, record NCT05645432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05645432
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
- NCT number
- NCT05645432
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Conditions
- Tinnitus
- Interventions
- Brexanolone
- First posted
- 2022-12-09
- Last updated
- 2025-09-15
- Results first posted
- 2024-12-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Up to Day 15 | 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. |
| Secondary | Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 | 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. |
| Secondary | Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 | 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. |
| Secondary | Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 | 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. |
| Secondary | Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 | 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. |
| Secondary | Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 | 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. |
| Secondary | Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 | 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. |
| Secondary | Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 | 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. |
| Secondary | Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Up to Day 15 | Safety set included all participants who received any amount of brexanolone. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | score on a scale | MEAN |
| SECONDARY | Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | score on a scale | MEAN |
| SECONDARY | Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | score on a scale | MEAN |
| SECONDARY | Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | score on a scale | MEAN |
| SECONDARY | Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group53
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) | Brexanolone | 1 | Participants | ||
| Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | Brexanolone | Change at Day 1, Hour 0.5 | -3.1 | Standard Deviation 8.33 | score on a scale |
| Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | Brexanolone | Change at Day 1, Hour 1 | -8.1 | Standard Deviation 14.13 | score on a scale |
| Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | Brexanolone | Change at Day 1, Hour 2 | -7.2 | Standard Deviation 14.41 | score on a scale |
| Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | Brexanolone | Change at Day 1, Hour 3 | -11.2 | Standard Deviation 14.54 | score on a scale |
| Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | Brexanolone | Change at Day 1, Hour 4 | -15.4 | Standard Deviation 16.26 | score on a scale |
| Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | Brexanolone | Change at Day 1, Hour 5 | -15.7 | Standard Deviation 15.72 | score on a scale |
| Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | Brexanolone | Change at Day 1, Hour 6 | -12.8 | Standard Deviation 9.32 | score on a scale |
| Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings | Brexanolone | Change at Day 1, Hour 0.5 | -3.10 | Standard Error 2.486 | score on a scale |
| Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings | Brexanolone | Change at Day 1, Hour 1 | -8.10 | Standard Error 4.441 | score on a scale |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brexanolone | 10 | |
| Overall Study | COMPLETED | Brexanolone | 9 | |
| Overall Study | NOT COMPLETED | Brexanolone | 1 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tinnitus | Ear and labyrinth disorders | Brexanolone | 1 | 10 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brexanolone | 0 | 10 |
| Total, other adverse events | Brexanolone | 1 | 10 |
| Total, serious adverse events | Brexanolone | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41341514 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05645432
GET https://conductscience.org/api/trials/v1/NCT05645432/results?page=2