TinnitusPhase 2NCT05645432
An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
A Phase 2 study testing Brexanolone in people with Tinnitus, run by Supernus Pharmaceuticals, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Brexanolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2023to 21 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sage Investigational Site
Atlanta, Georgia, 30331
Sage Investigational Site
Iowa City, Iowa, 52242
About this study
Official title: 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.
- Conditions
- Tinnitus
- Being tested
- Brexanolone
- Keywords
- Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexanoloneDrug
Also called Allopregnanolone, ZULRESSO®, SAGE-547
Brexanolone IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Brexanolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 15
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start10 May 2023
- Primary completion21 Nov 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645432
- Sponsor's protocol ID
- 547-TRM-201
- Status last verified
- Nov 2024
- First submitted
- 1 Dec 2022
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Publications
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.
PubMed 41341514
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Brexanolone in the Treatment of Adult Participants With Tinnitus
- ClinicalTrials.gov ID
- NCT05645432
- Acronym / sponsor ID
- 547-TRM-201
- Conditions
- Tinnitus
- Keywords
- Tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brexanolone | Experimental | Drug: BrexanoloneParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrexanoloneAlso: Allopregnanolone, ZULRESSO®, SAGE-547Brexanolone IV infusion | Drug | Brexanolone |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Time frame: 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.
8 secondary outcomes
Change From Baseline (Observed Value) to Hour 6 of Infusion in Visual Analog Scale-Loudness (VAS-L) Ratings
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline; Days 2, 3, 4, 5, 6, and 7 after brexanolone infusion given on Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41341514Watson 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.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brexanolone in people with Tinnitus, run by Supernus Pharmaceuticals, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAE) (time frame: Up to Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.