Phase 2
N=10
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT05645432 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAE) — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Brexanolone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Supernus Pharmaceuticals, Inc.
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAE) |
1 | — |
| SECONDARY Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings |
-3.1; -8.1; -7.2; -11.2; -15.4; -15.7 | — |
| SECONDARY Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-L Ratings |
-3.10; -8.10; -7.20; -11.20; -15.40; -15.70 | — |
| SECONDARY Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Annoyance (VAS-A) Ratings |
-7.6; -9.8; -16.6; -16.9; -21.3; -22.0 | — |
| SECONDARY Change From Baseline (Model Based) to Hour 6 of Infusion in VAS-A Ratings |
-7.60; -9.80; -16.60; -16.90; -21.30; -22.00 | — |
| SECONDARY Change From Baseline (Observed Value) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days |
-17.56; -17.51; -15.61; -16.76; -16.96; -11.31 | — |
| SECONDARY Change From Baseline (Model Based) to Post-infusion in VAS-L Ratings Measured Via Daily Diary Over Multiple Days |
-17.56; -17.51; -15.61; -16.76; -16.96; -11.31 | — |
| SECONDARY Change From Baseline (Observed Value) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days |
-19.41; -16.01; -13.41; -15.16; -11.51; -7.61 | — |
| SECONDARY Change From Baseline (Model Based) to Post-infusion in VAS-A Ratings Measured Via Daily Diary Over Multiple Days |
-19.41; -16.01; -13.41; -15.16; -11.51; -7.61 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT05645432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.