Agitation,PsychomotorPhase 3NCT05658510
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
A Phase 3 study testing BXCL501 in people with Agitation,Psychomotor and Bipolar I Disorder, run by BioXcel Therapeutics Inc at 24 sites in United States.
Trial summary
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder
- What is being tested?
- BXCL501
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 452 participants
- Where
- 24 sitesUnited States
- Study dates
- 21 Nov 2022to 15 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between the ages of 18 to 75 years, inclusive
- Patients who can read, understand and provide written informed consent.
- Patients who have met Diagnostic and Statistical Manual5/5-Text Revision criteria for bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder.
- Patients who, in the opinion of the Principal Investigator, are in good general health before study participation based on a detailed medical history, a physical examination, a 12-lead ECG, a blood chemistry profile, hematology, and urinalysis.
- Participants who agree to use a medically acceptable and effective birth control method
- Part 1 only
Show all 12Show fewer
- Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PEC.
- Patients with a score of ≥4 on at least 1 of the 5 items on the PEC at Baseline.
- Part 2 only
- Patients have had at least three clinical presentations of agitation requiring an intervention (e.g., receipt of as needed [PRN] medication for the episode, clinic visit, emergency room visit, emergency medical services intervention, law enforcement intervention) in the past three months prior to Screening
- Patients who are receiving stable psychotropic treatment for 30 days prior to Screening for the underlying primary diagnosis and who are expected to remain on stable treatment for the duration of the study.
- The patient can understand and follow the study procedures, including completing the Agitation Episode Diary.
Who cannot join
- Patients with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, or hematologic disease.
- A history of agitation episodes due to substance use.
- A diagnosis of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder that predated the diagnosis of schizophrenia or bipolar disorder
- Patients who are judged to be at significant risk of suicide
- Female patients who have a positive pregnancy test at Screening or Baseline, or are breastfeeding.
- Patients currently treated with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin), alpha-2 adrenergic agonists, or other prohibited medications.
Show all 28Show fewer
- Patients with hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease, or focal neurological findings.
- History of syncope or other syncopal attacks, current evidence of hypovolemia, or orthostatic hypotension
- Patients with laboratory or ECG abnormalities considered clinically significant by the Investigator
- Patients who have received an investigational drug within 30 days before the study start
- Patients who have previously received BXCL501 via prescription (under the trade name IGALMI™) or received BXCL501 in clinical trial
- Patients considered by the Investigator to be unsuitable candidates for receiving dexmedetomidine or considered to be unsuitable for participating in the study for any reason.
- Part 1 only
- Patients with agitation caused by acute intoxication, including identification of alcohol by breathalyzer or drugs of abuse (except for THC) during urine screening.
- Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 4 hours before study treatment.
- Part 2 only
- Psychiatric comorbidities are generally allowed; however, moderate or severe substance use disorders (SUD) (within the past 6 months) are exclusionary if the substance involved is other than nicotine or caffeine. Cannabis use is not exclusionary if it is not the focus of treatment in the last 6 months before Screening.
- Self-injurious behavior that is active.
- Patients with known personal or family history of genetic long QT syndrome.
- Informant Inclusion Criteria:
- At least 18 years of age at the time of screening.
- Is a spouse, significant other, family member, friend, or home health aide, residence manager of an adult patient who is determined to be eligible for the study per the patient inclusion/exclusion criteria.
- Has known the patient for at least 3 months cumulatively.
- Currently living with or routinely contacting the patient at least five days a week.
- Does not plan to discontinue contact with the patient during the study period.
- Willing and able to provide written informed consent.
- Willing and able to follow the study procedures, including completing the Agitation Episode Diary and other study procedures during the study.
- Willing and able to accompany patient and remain present at the clinical site during the clinic visits and be interviewed by the Investigator.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
BioXcel Clinical Research Site 136
Austin, Texas, 78754
BioXcel Clinical Research Site 122
Beachwood, Ohio, 44122
BioXcel Clinical Research Site 113
Bellflower, California, 90706
BioXcel Clinical Research Site 105
Berlin, New Jersey, 08009
BioXcel Clinical Research Site 128
Cerritos, California, 90703
BioXcel Clinical Research Site 110
Culver City, California, 90230
BioXcel Clinical Research Site 129
Denver, Colorado, 80209
BioXcel Clinical Research Site 102
DeSoto, Texas, 75115
BioXcel Clinical Research Site 130
Elgin, Illinois, 60123
BioXcel Clinical Research Site 126
Everett, Washington, 98201
BioXcel Clinical Research Site 103
Gaithersburg, Maryland, 20877
BioXcel Clinical Research Site 108
Garden Grove, California, 92845
BioXcel Clinical Research Site 125
Irving, Texas, 75062
BioXcel Clinical Research Site 118
Las Vegas, Nevada, 89102
BioXcel Clinical Research Site 137
Las Vegas, Nevada, 89119
BioXcel Clinical Research Site 117
Lemon Grove, California, 91945
BioXcel Clinical Research Site 121
Los Angeles, California, 90015
BioXcel Clinical Research Site 131
Miami, Florida, 33122
BioXcel Clinical Research Site 124
Miami, Florida, 33186
BioXcel Clinical Research Site 123
Oceanside, California, 92056
BioXcel Clinical Research Site 104
Orange, California, 92868
BioXcel Clinical Research Site 127
Plano, Texas, 75093
BioXcel Clinical Research Site 133
Rancho Cucamonga, California, 91730
BioXcel Clinical Research Site 114
Riverside, California, 92506
About this study
Official title: Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar Disorder
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, 2-Part, Phase III study to assess the efficacy, safety, and tolerability of BXCL501 in adult (18-75 years old) males and females with agitation episodes associated with a primary diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder. Part 1 of the study is a one-day, in-clinic treatment of 60 mcg dose, and post-treatment observation period with patients experiencing an acute episode of agitation. Part 1 is now complete. Part 2 of the study is a 12-week study to determine the safety of a BXCL501 120 mcg dose when used as needed for episodes of agitation at home.
- Conditions
- Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- Being tested
- BXCL501, Matching Placebo
- Medical subject headings
- Psychomotor Agitation, Bipolar Disorder, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXCL501Drug
Also called Dexmedetomidine
Sublingual Film
Matching PlaceboDrug
Also called Placebo
Sublingual Placebo Film
| Study group | Role | What they receive |
|---|---|---|
| Part 1: 60 mcg of BXCL501 | Experimental | Sublingual film containing 60 Micrograms Dexmedetomidine Receives: Drug: BXCL501 |
| Part 1: Matching Placebo | Placebo comparator | Sublingual Placebo film Receives: Drug: Matching Placebo |
| Part 2: 120 mcg of BXCL501 | Experimental | Sublingual film containing 120 Micrograms Dexmedetomidine Receives: Drug: BXCL501 |
| Part 2: Matching Placebo | Placebo comparator | Sublingual Placebo film Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total score
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Measured: 2 hours
Part 2: The incidence of SAEs and TEAEs compared with placebo.
To assess the safety of 120 mcg BXCL501 when used in an at-home environment based on serious adverse events (SAE) and treatment emergent adverse events (TEAEs).
Measured: Through study completion, an average of 12 weeks
Secondary outcomes (13)
Part 1: Clinical Global Impression - Improvement (CGI-I)
The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention. The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse.
Measured: 2 hours
Part 1: Change in Modified Clinical Global Impression - Severity (mCGI-S) scores from Baseline
The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation. For this study, the mCGI-S is a 4-point scale where a score of 0 represents no agitation, and scores of 1-3 describe increasing severities of agitation (mild, moderate, severe).
Measured: 2 hours
Part 1:The number of responders based on the Modified Clinical Global Impression - Severity (mCGI-S) score
The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation. A responder is characterized as a participant with a score of 0 (represents no agitation) or 1 (mild agitation)
Measured: 2 hours
Part 1:Change from baseline in Agitation-Calmness Evaluation Scale (ACES)
The Agitation-Calmness Evaluation Scale (ACES) is a single item scale that measures overall agitation and sedation, where a score of 1 indicates marked agitation; 2 - moderate agitation; 3 - mild agitation; 4 - normal behavior; 5 - mild calmness; 6 - moderate calmness; 7 - marked calmness; 8 - deep sleep; and 9 - unarousable.
Measured: 2 hours
Part 1: Incidence of treatment-emergent adverse events (TEAEs)
To assess the safety of BXCL501 based on treatment-emergent adverse events (TEAEs)
Measured: Through study completion, an average of 8 hours
Part 1: Change from baseline in heart rate (HR) at rest
The effect of BXCL501 on heart rate at rest
Measured: Baseline, and 2, 4, 6, and 8 hours postdose
Part 1: Change from baseline in heart rate (HR) under orthostatic stress
The effect of BXCL501 on heart rate under orthostatic stress
Measured: Baseline, and 2, 4, 6, and 8 hours postdose
Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at rest
The effect of BXCL501 on systolic and diastolic blood pressure at rest
Measured: Baseline, and 2, 4, 6, and 8 hours postdose
Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) under orthostatic stress
The effect of BXCL501 on systolic and diastolic blood pressure under orthostatic stress
Measured: Baseline, and 2, 4, 6, and 8 hours postdose
Part 1: Incidence of abnormal electrocardiograms (ECG) reported as an adverse event (AE)
Any abnormal ECG value that is reported as an adverse event (AE)
Measured: Through study completion, an average of 8 hours
Part 1: Incidence of abnormal clinical laboratory values reported as an adverse event (AE)
Any abnormal clinical laboratory value that is reported as an adverse event (AE)
Measured: Through study completion, an average of 8 hours
Part 2: Incidence of interactions with emergency services related to agitation
Evaluate the impact of BXCL501 on the use of healthcare and emergency service resources because of agitation episodes
Measured: Through study completion, an average of 12 weeks
Part 2: Incidence of overall adverse events and AEs leading to discontinuation
To evaluate the safety and tolerability profile of 120 mcg BXCL501
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start21 Nov 2022
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation,PsychomotorStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: Patients randomized to receive 60 mcg of BXCL501 or a matching placebo. Part 2: Patients randomized to receive 120 mcg of BXCL501 or a matching placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioXcel Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Responsible party
- Sponsor
- Investigators
- BioXcel MM, Study chair, BioXcel Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658510
- Sponsor's protocol ID
- BXCL501-401
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar Disorder
- ClinicalTrials.gov ID
- NCT05658510
- Acronym / sponsor ID
- BXCL501-401
- Conditions
- Agitation,Psychomotor, Bipolar I Disorder, Bipolar II Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- BioXcel Therapeutics IncIndustry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.
Detailed description
This is a randomized, double-blind, placebo-controlled, 2-Part, Phase III study to assess the efficacy, safety, and tolerability of BXCL501 in adult (18-75 years old) males and females with agitation episodes associated with a primary diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder. Part 1 of the study is a one-day, in-clinic treatment of 60 mcg dose, and post-treatment observation period with patients experiencing an acute episode of agitation. Part 1 is now complete. Part 2 of the study is a 12-week study to determine the safety of a BXCL501 120 mcg dose when used as needed for episodes of agitation at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Part 1: Patients randomized to receive 60 mcg of BXCL501 or a matching placebo. Part 2: Patients randomized to receive 120 mcg of BXCL501 or a matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Part 1: 60 mcg of BXCL501 | Experimental | Drug: BXCL501Sublingual film containing 60 Micrograms Dexmedetomidine |
| Part 1: Matching Placebo | Placebo comparator | Drug: Matching PlaceboSublingual Placebo film |
| Part 2: 120 mcg of BXCL501 | Experimental | Drug: BXCL501Sublingual film containing 120 Micrograms Dexmedetomidine |
| Part 2: Matching Placebo | Placebo comparator | Drug: Matching PlaceboSublingual Placebo film |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female patients between the ages of 18 to 75 years, inclusive
- Patients who can read, understand and provide written informed consent.
- Patients who have met Diagnostic and Statistical Manual5/5-Text Revision criteria for bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder.
- Patients who, in the opinion of the Principal Investigator, are in good general health before study participation based on a detailed medical history, a physical examination, a 12-lead ECG, a blood chemistry profile, hematology, and urinalysis.
- Participants who agree to use a medically acceptable and effective birth control method
Key exclusion criteria (28 listed)
- Patients with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, or hematologic disease.
- A history of agitation episodes due to substance use.
- A diagnosis of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder that predated the diagnosis of schizophrenia or bipolar disorder
- Patients who are judged to be at significant risk of suicide
- Female patients who have a positive pregnancy test at Screening or Baseline, or are breastfeeding.
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 |
|---|---|---|
| BXCL501Also: DexmedetomidineSublingual Film | Drug | Part 1: 60 mcg of BXCL501, Part 2: 120 mcg of BXCL501 |
| Matching PlaceboAlso: PlaceboSublingual Placebo Film | Drug | Part 1: Matching Placebo, Part 2: Matching Placebo |
Primary outcome
Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total score
Time frame: 2 hours
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Part 2: The incidence of SAEs and TEAEs compared with placebo.
Time frame: Through study completion, an average of 12 weeks
To assess the safety of 120 mcg BXCL501 when used in an at-home environment based on serious adverse events (SAE) and treatment emergent adverse events (TEAEs).
13 secondary outcomes
Part 1: Clinical Global Impression - Improvement (CGI-I)
Time frame: 2 hours
Part 1: Change in Modified Clinical Global Impression - Severity (mCGI-S) scores from Baseline
Time frame: 2 hours
Part 1:The number of responders based on the Modified Clinical Global Impression - Severity (mCGI-S) score
Time frame: 2 hours
Part 1:Change from baseline in Agitation-Calmness Evaluation Scale (ACES)
Time frame: 2 hours
Part 1: Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Through study completion, an average of 8 hours
Part 1: Change from baseline in heart rate (HR) at rest
Time frame: Baseline, and 2, 4, 6, and 8 hours postdose
Part 1: Change from baseline in heart rate (HR) under orthostatic stress
Time frame: Baseline, and 2, 4, 6, and 8 hours postdose
Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at rest
Time frame: Baseline, and 2, 4, 6, and 8 hours postdose
Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) under orthostatic stress
Time frame: Baseline, and 2, 4, 6, and 8 hours postdose
Part 1: Incidence of abnormal electrocardiograms (ECG) reported as an adverse event (AE)
Time frame: Through study completion, an average of 8 hours
Part 1: Incidence of abnormal clinical laboratory values reported as an adverse event (AE)
Time frame: Through study completion, an average of 8 hours
Part 2: Incidence of interactions with emergency services related to agitation
Time frame: Through study completion, an average of 12 weeks
Part 2: Incidence of overall adverse events and AEs leading to discontinuation
Time frame: Through study completion, an average of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
BioXcel MM study chair
BioXcel Therapeutics
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BXCL501 in people with Agitation,Psychomotor and Bipolar I Disorder, run by BioXcel Therapeutics Inc at 24 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 12 inclusion and 28 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total score (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.