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The primary objective of this study is to evaluate the safety and tolerability of brexanolone in participants with tinnitus following a single 6-hour continuous intravenous (IV) infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brexanolone | Experimental | Participants will receive 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexanolone | Drug | Brexanolone IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) | 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. | Up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sage Investigational Site | Atlanta | Georgia | 30331 | United States | ||
| Sage Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41341514 | Derived | Watson LS, O'Donnell P, Bankole K, Toubouti Y, Tyler RS, Johannesen JK. An open-label, proof-of-mechanism trial evaluating a neuroactive steroid GABA modulator in tinnitus. Front Neurol. 2025 Nov 18;16:1662226. doi: 10.3389/fneur.2025.1662226. eCollection 2025. |
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Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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A total of 29 participants were screened, of which 10 were enrolled and treated.
Participants were enrolled at one active clinical site in the United States from 10 May 2023 to 21 November 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Safety set included all participants who received any amount of brexanolone.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brexanolone | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAE) | 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. | Safety set included all participants who received any amount of brexanolone. | Posted | Count of Participants | Participants | Up to Day 15 |
|
Up to Day 15
Safety set included all participants who received any amount of brexanolone.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brexanolone | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA (25.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Monitor | Sage Therapeutics | (617) 299-8380 | info@sagerx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 17, 2023 | Nov 18, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2024 | Nov 18, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| C000625635 | brexanolone |
| D011280 | Pregnanolone |
| ID | Term |
|---|---|
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 |
| Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings | 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. | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 |
| Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings | 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. | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 |
| Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings | 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. | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 |
| Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days | 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. | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 |
| Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days | 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. | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 |
| Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days | 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. | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 |
| Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days | 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. | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | 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.
|
|
| Secondary | Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings | 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. | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 |
|
|
|
| Secondary | Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings | 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. | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 |
|
|
|
| Secondary | Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings | 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. | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 |
|
|
|
| Secondary | Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings | 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. | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline; 0.5, 1, 2, 3, 4, 5, and 6 hours during brexanolone infusion on Day 1 |
|
|
|
| Secondary | Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days | 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. | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 |
|
|
|
| Secondary | Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days | 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. | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 |
|
|
|
| Secondary | Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days | 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. | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | score on a scale | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 |
|
|
|
| Secondary | Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days | 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. | Efficacy set included all participants who received any amount of brexanolone and had at least one post-baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1 |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
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).
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Change at Day 1, Hour 3 |
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| Change at Day 1, Hour 4 |
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| Change at Day 1, Hour 5 |
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| Change at Day 1, Hour 6 |
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| Title | Measurements |
|---|---|
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| Change at Day 1, Hour 3 |
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| Change at Day 1, Hour 4 |
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| Change at Day 1, Hour 5 |
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| Change at Day 1, Hour 6 |
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| Title | Measurements |
|---|---|
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| Change at Day 1, Hour 3 |
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| Change at Day 1, Hour 4 |
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| Change at Day 1, Hour 5 |
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| Change at Day 1, Hour 6 |
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| Title | Measurements |
|---|---|
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| Change at Day 1, Hour 3 |
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| Change at Day 1, Hour 4 |
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| Change at Day 1, Hour 5 |
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| Change at Day 1, Hour 6 |
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| Title | Measurements |
|---|---|
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| Change at Day 5 |
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| Change at Day 6 |
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| Change at Day 7 |
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| Title | Measurements |
|---|---|
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| Change at Day 5 |
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| Change at Day 6 |
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| Change at Day 7 |
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| Title | Measurements |
|---|---|
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| Change at Day 5 |
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| Change at Day 6 |
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| Change at Day 7 |
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| Title | Measurements |
|---|---|
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| Change at Day 5 |
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| Change at Day 6 |
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| Change at Day 7 |
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