- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05645432
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
December 21, 2023 updated by: Sage Therapeutics
An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Brexanolone in the Treatment of Adult Participants With Tinnitus
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30331
- Sage Investigational Site
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Iowa
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Iowa City, Iowa, United States, 52242
- Sage Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participant has a designated companion for the Clinic Treatment Visit who will drive them when they leave the clinic
- Participant is in good physical health and has no clinically significant findings (excluding tinnitus), as determined by the investigator on medical history and physical examination, including neurologic and mental status examinations, 12-lead electrocardiogram (ECG), or clinical laboratory tests
- Participant has a diagnosis of subjective, idiopathic, unilateral or bilateral, non-pulsatile tinnitus (e.g., not due to medical disease) of ≥6 months and <10 years duration
- Participant has mild to severe tinnitus distress according to Tinnitus Handicap Inventory (THI) score of 24 to 68 at Screening
- Participant is willing and able to safely discontinue the use of central nervous system (CNS) depressants (e.g., opioids and benzodiazepines), antidepressants, anticonvulsants, CNS stimulants (with the exception of caffeine), aspirin, other nonsteroidal anti inflammatory drugs, and aminoglycosides at least 14 days or 5 half-lives (whichever is longer) prior to receiving IP and through completion of the study
Exclusion Criteria:
- Participant has history or presence of any neurologic disease or condition, including, but not limited to, unexplained loss of consciousness, seizure disorder including a prior nonfebrile seizure, and closed head trauma with clinically significant sequelae
- Participant has a history of sleep apnea or any clinically significant respiratory conditions that may predispose the participant to hypoxia during the infusion
- Participant intends to start or discontinue a pharmacological or nonpharmacological therapy (e.g., psychotherapy, sound therapy, masking, transcranial magnetic stimulation [TMS]) for tinnitus during the course of the study
- Participant has currently active and medically significant or uncontrolled hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, immunologic, metabolic disease (hypothyroidism with stable thyroid replacement is acceptable)
- Participant's tinnitus can be modulated by maneuvers of the temporomandibular joint, head and neck, eyes, or limbs, or otherwise attributed to somatosensory cause or has had prior otoscopic surgeries or cholesteatoma
- Participants has current unilateral or bilateral hearing loss of 30 decibel (dB) or greater (mild hearing loss) in one or more tested frequencies (500 Hertz [Hz], 1000 Hz, 2000 Hz, and 4000 Hz), 60 dB or greater at 6000 Hz and 8000 Hz, asymmetry of 30 dB or greater in two or more tested frequencies, or uses a cochlear implant or hearing aid
- Participant has history of chronic otitis media (>3 per year during past 5 years)
- Participant has a total score of 15 or greater (i.e., moderately severe) on the Patient Health Questionnaire-9 (PHQ-9) at Screening
- Participant has diagnosis of moderate or severe substance use disorder (excluding nicotine dependence) within 12 months of Screening, has a positive screen for drugs of abuse including tetrahydrocannabinol (THC) on Day 1 prior to dosing, or has a positive screen for alcohol on Day 1 prior to dosing
- Participant has a known allergy to progesterone, allopregnanolone, or any IP excipient
- Participant has had exposure to another investigational drug or device within 30 days or 5 half-lives of the investigational drug, whichever is longer, prior to the Day 1 visit
- Participant has a history of suicidal behavior within 2 years or answers "YES" to Questions 3, 4, or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or at Day 1 or is currently at risk of suicide in the opinion of the investigator
- Participant has donated 1 or more units (1 unit = 450 milliliter [mL]) of blood or experienced acute loss of an equivalent amount of blood within 60 days prior to Day 1
- Participant has any condition, comorbidity, or lifestyle consideration that in the opinion of the investigator would limit or interfere with the participant's ability to complete or partake in the study
- Participant is unwilling or unable to comply with study procedures and the required training during the Baseline Period. The participant must complete 10 VAS assessments remotely prior to Day 1
- Participant is unable to complete participation in the study, e.g., due to preplanned event including elective surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Brexanolone
Participants will receive a continuous, 6-hour IV infusion of Brexanolone on Day 1 of the Treatment Period.
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Brexanolone IV infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Time Frame: Up to approximately 7 days
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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.
A TEAE is defined as an AE with onset after the start of investigational product (IP), or any worsening of a pre-existing medical condition/adverse event with onset after the start of IP and throughout the study.
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Up to approximately 7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings
Time Frame: Baseline, up to 6 hours of IP Infusion on Day 1
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VAS-L is a subject-rated scale for evaluating tinnitus.
Participants will answer the question "How loud is your tinnitus now?" on a horizontal scale anchored on left by "not audible" and on right by "extremely loud".
Scoring for it will be assessed in a linear vertical scale, with the left side being not audible (score of 0) and the right side being extremely loud (score of 100).
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Baseline, up to 6 hours of IP Infusion on Day 1
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Change From Baseline to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings
Time Frame: Baseline, up to 6 hours of IP Infusion on Day 1
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VAS-A is a subject-rated scale for evaluating tinnitus.
Participants will answer the question "How much is your tinnitus annoying you now?" on a horizontal scale anchored on left by "not annoying" and on right by "extremely annoying".
Scoring for it will be assessed in a linear vertical scale, with the left side being not annoying (score of 0) and the right side being extremely annoying (score of 100).
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Baseline, up to 6 hours of IP Infusion on Day 1
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Change From Baseline to Post-infusion in VAS-L Ratings Measured via Daily Diary Over Multiple Days
Time Frame: Baseline, up to approximately 6 days from Day 2 to Day 7 after IP infusion given on Day 1
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VAS-L is a subject-rated scale for evaluating tinnitus.
Participants will answer the question "How loud is your tinnitus now?" on a horizontal scale anchored on left by "not audible" and on right by "extremely loud" via daily diary over multiple days.
Scoring for it will be assessed in a linear vertical scale, with the left side being not audible (score of 0) and the right side being extremely loud (score of 100).
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Baseline, up to approximately 6 days from Day 2 to Day 7 after IP infusion given on Day 1
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Change From Baseline to Post-infusion in VAS-A Ratings Measured via Daily Diary Over Multiple Days
Time Frame: Baseline, up to approximately 6 days from Day 2 to Day 7 after IP infusion given on Day 1
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VAS-A is a subject-rated scale for evaluating tinnitus.
Participants will answer the question "How much is your tinnitus annoying you now?" on a horizontal scale anchored on left by "not annoying" and on right by "extremely annoying" via daily diary over multiple days.
Scoring for it will be assessed in a linear vertical scale, with the left side being not annoying (score of 0) and the right side being extremely annoying (score of 100).
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Baseline, up to approximately 6 days from Day 2 to Day 7 after IP infusion given on Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2023
Primary Completion (Actual)
November 21, 2023
Study Completion (Actual)
November 21, 2023
Study Registration Dates
First Submitted
December 1, 2022
First Submitted That Met QC Criteria
December 1, 2022
First Posted (Actual)
December 9, 2022
Study Record Updates
Last Update Posted (Actual)
December 22, 2023
Last Update Submitted That Met QC Criteria
December 21, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Ear Diseases
- Sensation Disorders
- Hearing Disorders
- Tinnitus
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Anesthetics
- GABA Modulators
- GABA Agents
- Neurosteroids
- Brexanolone
- Pregnanolone
Other Study ID Numbers
- 547-TRM-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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