Post-Traumatic Stress DisorderPhase 2ATTUNENCT04951076
A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD)
A Phase 2 study testing BNC210 in people with Post-Traumatic Stress Disorder, run by Bionomics Limited at 32 sites in 2 countries.
Trial summary
The purpose of this study is to assess the effects of BNC210 compared to placebo on Post-Traumatic Stress Disorder (PTSD) symptom severity as measured by the Clinician Administered PTSD scale for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- BNC210
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 27 Jul 2021to 14 Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with a current diagnosis of PTSD as defined by the CAPS-5 for DSM-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at Screening and Baseline and no >25% decrease in Score from Screening to Baseline
- The index trauma event must have occurred in adulthood, i.e., when the participant was ≥18 years of age
- Suitable contraception use in line with protocol requirements
- Ability to swallow tablets
Who cannot join
- A period of less than 6 months since the index trauma event
- Current and ongoing exposure to the trauma that caused the PTSD
- Complex PTSD
- Severe depression as measured by a score of ≥ 35 on the Montgomery Asberg Depression Rating Scale (MADRS)
- Borderline personality disorder, bipolar disorder and other psychotic disorders
- Use of antidepressant medications within 30 days (fluoxetine within 90 days) of Screening. The use of alprazolam, flunitrazepam and chronic daily use of other benzodiazepines within 90 day of Screening.
Show all 10Show fewer
- Failed more than three trials of antidepressant medication(s) prescribed for the treatment of PTSD.
- Concurrent trauma-based psychotherapy such as Cognitive Behavior Therapy, Prolonged Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy. Participants may however continue to receive supportive counseling that has been in place for a minimum of three months prior to Screening.
- Any moderate or severe substance use disorder in the past 12 months
- Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States25 sites
ATTUNE Study Clinical Trial Site
Austin, Texas, 78737
ATTUNE Study Clinical Trial Site
Bellflower, California, 90706
ATTUNE Study Clinical Trial Site
Berlin, New Jersey, 08009
ATTUNE Study Clinical Trial Site
Beverly Hills, California, 90210
ATTUNE Study Clinical Trial Site
Cedarhurst, New York, 11516
ATTUNE Study Clinical Trial Site
Cherry Hill, New Jersey, 08002
ATTUNE Study Clinical Trial Site
Colton, California, 92324
ATTUNE Study Clinical Trial Site
Dallas, Texas, 75231
ATTUNE Study Clinical Trial Site
Draper, Utah, 84020
ATTTUNE Study Clinical Trial Site
Jacksonville, Florida, 32256
ATTUNE Study Clinical Trial Site
Las Vegas, Nevada, 89102
ATTUNE Study Clinical Trial Site
Lauderhill, Florida, 33319
ATTUNE Study Clinical Trial Site
Memphis, Tennessee, 38119
ATTUNE Study Clinical Trial Site
Miami Lakes, Florida, 33016
ATTUNE Study Clinical Trial Site
New Bedford, Massachusetts, 02740
ATTUNE Study Clinical Trial Site
North Canton, Ohio, 44720
ATTUNE Study Clinical Trial Site
Oceanside, California, 92056
ATTUNE Study Clinical Trial Site
Oklahoma City, Oklahoma, 73106
ATTUNE Study Clinical Trial Site
Orange, California, 92868
ATTUNE Study Clinical Trial Site
Orlando, Florida, 32801
ATTUNE Study Clinical Trial Site
Overland Park, Kansas, 66221
ATTUNE Study Clinical Trial Site
Prairie Village, Kansas, 66208
ATTUNE Study Clinical Trial Site
Staten Island, New York, 10312
ATTUNE Study Clinical Trial Site
Temecula, California, 92591
ATTUNE Study Clinical Trial Site
West Chester, Pennsylvania, 19380
United Kingdom7 sites
ATTUNE Study Clinical Trial Site
Barnsley, S75 3DL
ATTUNE Study Clinical Trial Site
Blackpool, FY2 0JH
ATTUNE Study Clinical Trial Site
Cannock, WS11 0BN
ATTUNE Study Clinical Trial Site
Leeds, LS10 1DU
ATTUNE Study Clinical Trial Site
Liverpool, L34 1BH
ATTUNE Study Clinical Trial Site
Manchester, M13 9NQ
ATTUNE Study Clinical Trial Site
Stockton-on-Tees, TS17 6EW
About this study
Official title: A Phase 2b, Randomized, Double Blind, Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults With Post-Traumatic Stress Disorder (PTSD)
The purpose of this study is to assess the effects of BNC210 compared to placebo on Post-Traumatic Stress Disorder (PTSD) symptom severity as measured by the Clinician Administered PTSD scale for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study with a 12 week, 2-arm treatment period. Participants will attend a Screening visit within 3 weeks before randomization to confirm eligibility. Approximately 200 participants will be randomized using a 1:1 ratio to receive either BNC210 900 mg twice daily (b.i.d.) or matched placebo. Participants will then complete 12 weeks of treatment with their allocated study intervention. Participants will return to their study site at 2-weekly intervals to complete study assessments. Participants are then requested to attend a Follow-up visit at Week 15 (i.e., 3 weeks after their last study intervention is administered).
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- BNC210, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNC210Drug
BNC210 900 mg twice daily (b.i.d.) for 12 weeks
PlaceboDrug
Placebo twice daily (b.i.d.) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| BNC210 | Experimental | Not described Receives: Drug: BNC210 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks
The CAPS-5 is a 30-item structured interview used to diagnose PTSD and assess PTSD symptoms over the past month. Information about the frequency and intensity of each item is combined into a severity rating, and the CAPS-5 total symptom severity score is calculated by adding the severity scores for the 20 PTSD symptoms in the DSM-5. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Measured: Baseline, 4 weeks, 8 weeks,12 weeks
Secondary outcomes (11)
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks
Criterion B (Intrusive Thoughts) is a 5-item sub section of the CAPS-5 scale that assesses intrusion symptoms associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 20, with higher scores indicating greater severity of intrusion symptoms.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks
Criterion C (Avoidance) is a 2-item sub section of the CAPS-5 scale that assesses avoidance of stimuli associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 8, with higher scores indicating greater severity of avoidance symptoms.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks
Criterion D (Negative Alterations in Cognitions and Mood) is a 7-item sub section of the CAPS-5 scale that assesses negative alterations in cognitions and mood associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 28, with higher scores indicating greater severity of negative alterations in cognitions and mood symptoms.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks
Criterion E (Arousal and Reactivity) is a 6-item sub section of the CAPS-5 scale that assesses marked alterations in arousal and reactivity associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 24, with higher scores indicating greater severity of arousal and reactivity symptoms.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks
The MADRS is a 10-item clinician-rated questionnaire to measure the presence and severity of depressive episodes. Each item is rated on a scale of 0 to 6. The score from each item is combined into a total score ranging from 0 to 60, with higher scores indicating greater severity of depressive episodes.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks
The HAM-A is an interview questionnaire that measures severity of anxiety symptoms based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior during the interview. Each parameter is rated on a scale of 0 (not present) to 4 (very severe). The score from each parameter is combined into a total score. Scores range from 0 to 56, with higher scores indicating greater severity of anxiety symptoms.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks
The CGI-S is a rating scale designed to assess the overall severity of the participant's symptoms. Severity is rated on a scale from 1 (normal, not at all ill) to 7 (among the most extremely ill of participants), with a higher score indicating greater severity of symptoms.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks
Change from Baseline on patient-reported global functioning
The PGI-S is a patient self-reported counterpart of the CGI-S designed to assess the patient's impression of their perceived severity of overall symptoms.Severity is rated on the PGI-S from 1 (normal) to 6 (very severe), with a higher score indicating greater severity of symptoms.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks
The ISI is a brief self-report instrument measuring both nocturnal and diurnal symptoms of insomnia. The ISI comprises seven items, each scored from 0 to 4. The scores from each of the 7 questions are added up to get a total score of 0 to 28, with a higher score indicating a higher level of symptom severity.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Sheehan Disability Scale (SDS) Scores After 12 Weeks
The SDS is a rating scale designed to measure impairment in three domains: work/school, social life, and family life/home responsibilities. Each item is rated on a scale of 0 (not at all) to 10 (extremely), for a total score of 0 to 30, with a higher score indicating a higher degree of impairment.
Measured: Baseline, 4 weeks, 8 weeks,12 weeks
Change From Baseline on PTSD Checklist for DSM-5 (PCL-5) Scores After 12 Weeks
The PCL-5 is a 20-item self-report assessment of the 20 DSM-5 symptoms of PTSD. Each symptom is rated on a scale from 0 (not at all) to 4 (extremely). Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start27 Jul 2021
- Primary completion25 Jul 2023
- Study completion14 Aug 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 Post-Traumatic Stress DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionomics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951076
- Sponsor's protocol ID
- BNC210.012
- Acronym
- ATTUNE
- Status last verified
- Dec 2024
- First submitted
- 27 Jun 2021
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papapetropoulos S, Doolin E, O'Connor S, Paul D, Odontiadis M, Jaros M, Rolan P, Stein MB. BNC210, an alpha7 Nicotinic Receptor Modulator, in Post-Traumatic Stress Disorder. NEJM Evid. 2025 Jan;4(1):EVIDoa2400380. doi: 10.1056/EVIDoa2400380. Epub 2024 Dec 8.
PubMed 39647171
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double Blind, Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults With Post-Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT04951076
- Acronym / sponsor ID
- ATTUNE / BNC210.012
- Conditions
- Post-Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Bionomics LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects of BNC210 compared to placebo on Post-Traumatic Stress Disorder (PTSD) symptom severity as measured by the Clinician Administered PTSD scale for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study with a 12 week, 2-arm treatment period. Participants will attend a Screening visit within 3 weeks before randomization to confirm eligibility. Approximately 200 participants will be randomized using a 1:1 ratio to receive either BNC210 900 mg twice daily (b.i.d.) or matched placebo. Participants will then complete 12 weeks of treatment with their allocated study intervention. Participants will return to their study site at 2-weekly intervals to complete study assessments. Participants are then requested to attend a Follow-up visit at Week 15 (i.e., 3 weeks after their last study intervention is administered).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BNC210 | Experimental | Drug: BNC210 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with a current diagnosis of PTSD as defined by the CAPS-5 for DSM-5, with a CAPS-5 Total Symptom Severity Score of ≥30 at Screening and Baseline and no >25% decrease in Score from Screening to Baseline
- The index trauma event must have occurred in adulthood, i.e., when the participant was ≥18 years of age
- Suitable contraception use in line with protocol requirements
- Ability to swallow tablets
Key exclusion criteria (10 listed)
- A period of less than 6 months since the index trauma event
- Current and ongoing exposure to the trauma that caused the PTSD
- Complex PTSD
- Severe depression as measured by a score of ≥ 35 on the Montgomery Asberg Depression Rating Scale (MADRS)
- Borderline personality disorder, bipolar disorder and other psychotic disorders
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 |
|---|---|---|
| BNC210BNC210 900 mg twice daily (b.i.d.) for 12 weeks | Drug | BNC210 |
| PlaceboPlacebo twice daily (b.i.d.) for 12 weeks | Drug | Placebo |
Primary outcome
Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks,12 weeks
The CAPS-5 is a 30-item structured interview used to diagnose PTSD and assess PTSD symptoms over the past month. Information about the frequency and intensity of each item is combined into a severity rating, and the CAPS-5 total symptom severity score is calculated by adding the severity scores for the 20 PTSD symptoms in the DSM-5. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
11 secondary outcomes
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change From Baseline on Sheehan Disability Scale (SDS) Scores After 12 Weeks
Time frame: Baseline, 4 weeks, 8 weeks,12 weeks
Change From Baseline on PTSD Checklist for DSM-5 (PCL-5) Scores After 12 Weeks
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39647171Papapetropoulos S, Doolin E, O'Connor S, Paul D, Odontiadis M, Jaros M, Rolan P, Stein MB. BNC210, an alpha7 Nicotinic Receptor Modulator, in Post-Traumatic Stress Disorder. NEJM Evid. 2025 Jan;4(1):EVIDoa2400380. doi: 10.1056/EVIDoa2400380. Epub 2024 Dec 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BNC210 in people with Post-Traumatic Stress Disorder, run by Bionomics Limited at 32 sites in 2 countries.
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 4 inclusion and 10 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, United Kingdom. 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 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 6 Feb 2025). 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?
Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks (time frame: Baseline, 4 weeks, 8 weeks,12 weeks). 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 NCT04951076, 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 6 Feb 2025.