Post Stroke DepressionPhase 2ALLO in PSDNCT06759558
Allopregnanolone (Zuranolone) in Post-stroke Depression
A Phase 2 study testing Zuranolone in people with Post Stroke Depression, run by Duke University at 1 site in United States.
Trial summary
The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Post Stroke Depression
- What is being tested?
- Zuranolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21-65 years old of any sex and race/ethnicity
- Clinical ischemic or hemorrhagic acute stroke (confirmed by CT or MRI) occurring within 1 year of date of enrollment
- Moderate to severe PSD (Post-Stroke Depression) defined as having depressive symptoms lasting for at least 2 weeks and scoring 17 or more on the HAM-D (Hamilton Depression Rating Scale)
Who cannot join
- Have abused or been dependent on narcotics, recreational drug use, or alcohol
- Advanced liver or kidney problems
- Pregnant or plan to become pregnant
- Post-partum period or breastfeeding
- History of attempted suicide
- Active psychosis or suicidal ideation necessitating clinical intervention
- Antidepressant medications titration or initiation within 12 weeks of recruitment
- History of Bipolar disorder, schizophrenia or treatment resistant depression preceding the stroke
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke South Neurology Clinic 1L
Durham, North Carolina, 27710-0400
Nada El Husseini, MD, 919-970-2091, nada.elhusseini@duke.edu
Sheila N Joshi, BA, 9196841992, sheila.joshi@duke.edu
About this study
The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are:
- Is zuranolone safe to take by participants who have moderate to severe post-stroke depression?
- Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression?
- Does zuranolone treat moderate to severe post-stroke depression?
Read more
The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days.
Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.
- Conditions
- Post Stroke Depression
- Being tested
- Zuranolone
- Keywords
- zuranolone, post stroke depression, allopregnanolone, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZuranoloneDrug
Zuranolone is a neuroactive steroid that works by modulating the activity of the gamma-aminobutyric acid (GABA) receptor in the brain.
| Study group | Role | What they receive |
|---|---|---|
| Zuranolone | Experimental | Participants in the Zuranolone arm will be treated for post-stroke depression for 14 days with 50mg of zuranolone once daily. Receives: Drug: Zuranolone |
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 (TEAEs) after starting zuranolone
TEAEs: suicidality and signs of abuse/dependence such as suicidal thinking and associated behaviors, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania, psychosis, worsening depression.
Other TEAEs include: dizziness, somnolence, significant drowsiness causing impairment of daily activity, skin rash, abdominal pain, diarrhea, urinary tract infection, fatigue, memory impairment, tremor, muscle twitching, myalgia, headache, hypoesthesia, recurrent stroke, hypertension, hypotension, falls, confusion.
Measured: 90 days
Severity of suicidal ideation after starting zuranolone as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS will be used to evaluate the intensity of suicidal ideation. The score ranges from 2 to 25, where a higher score indicates greater ideation.
Measured: 90 Days
Severity of somnolence after starting zuranolone as measured by the Epworth Sleepiness Scale (ESS)
The ESS will be used to evaluate the intensity of somnolence. The score ranges from 0 to 24, where a score from 11-24 indicates excessive daytime sleepiness.
Measured: 90 Days
Secondary outcomes (4)
Change from baseline in Hamilton Depression Rating Scale (HAM-D) score at days 15 and 90
A mixed-effects model for repeated measures will be used for the secondary exploratory outcome and will include change from baseline in HAM-D at each visit as the dependent variable. Logistic regression models for repeated measures using the generalized estimating equation method will be applied for analysis of HAM-D response and HAM-D remission.
HAM-D score ranges from 0-50. In general the higher the total score the more severe the depression.
Measured: Baseline, 15 days, 90 days
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at days 15 and 90
The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety.
Measured: Baseline, 15 days, 90 days
Number of participants with HAM-D response at 3, 15, and 90 days
The HAM-D total score ranges from 0 to 54, with higher scores indicating greater severity of depression. Response is defined as having a > or = 50% score reduction.
Measured: 3 days, 15 days, 90 days
Number of participants with HAM-D remission (score ≤7) rates at 3, 15, and 90 days
The HAM-D total score ranges from 0 to 54, with higher scores indicating greater severity of depression. Remission is defined as having a score < or = 7.
Measured: 3 days, 15 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start30 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Post Stroke DepressionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Nada El Husseini, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759558
- Sponsor's protocol ID
- Pro00118406
- Acronym
- ALLO in PSD
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared via publications and/or presentations
Publications
Wang S, Zhang W, Liu Z, Zhang T, Wang Y, Li W. Efficacy and safety of zuranolone in the treatment of major depressive disorder: a meta-analysis. Front Neurosci. 2024 Jan 16;17:1332329. doi: 10.3389/fnins.2023.1332329. eCollection 2023.
PubMed 38292895Clayton AH, Lasser R, Parikh SV, Iosifescu DV, Jung J, Kotecha M, Forrestal F, Jonas J, Kanes SJ, Doherty J. Zuranolone for the Treatment of Adults With Major Depressive Disorder: A Randomized, Placebo-Controlled Phase 3 Trial. Am J Psychiatry. 2023 Sep 1;180(9):676-684. doi: 10.1176/appi.ajp.20220459. Epub 2023 May 3.
PubMed 37132201Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):951-959. doi: 10.1001/jamapsychiatry.2021.1559.
PubMed 34190962Sripada RK, Marx CE, King AP, Rampton JC, Ho SS, Liberzon I. Allopregnanolone elevations following pregnenolone administration are associated with enhanced activation of emotion regulation neurocircuits. Biol Psychiatry. 2013 Jun 1;73(11):1045-53. doi: 10.1016/j.biopsych.2012.12.008. Epub 2013 Jan 21.
PubMed 23348009Chen S, Gao L, Li X, Ye Y. Allopregnanolone in mood disorders: Mechanism and therapeutic development. Pharmacol Res. 2021 Jul;169:105682. doi: 10.1016/j.phrs.2021.105682. Epub 2021 May 18.
PubMed 34019980Pinna G, Almeida FB, Davis JM. Allopregnanolone in Postpartum Depression. Front Glob Womens Health. 2022 Apr 26;3:823616. doi: 10.3389/fgwh.2022.823616. eCollection 2022.
PubMed 35558166Diviccaro S, Cioffi L, Falvo E, Giatti S, Melcangi RC. Allopregnanolone: An overview on its synthesis and effects. J Neuroendocrinol. 2022 Feb;34(2):e12996. doi: 10.1111/jne.12996. Epub 2021 Jun 29.
PubMed 34189791Chen S, Wang T, Yao J, Brinton RD. Allopregnanolone Promotes Neuronal and Oligodendrocyte Differentiation In Vitro and In Vivo: Therapeutic Implication for Alzheimer's Disease. Neurotherapeutics. 2020 Oct;17(4):1813-1824. doi: 10.1007/s13311-020-00874-x.
PubMed 32632771Dymm B, Goldstein LB, Unnithan S, Al-Khalidi HR, Koltai D, Bushnell C, Husseini NE. Depression following small vessel stroke is common and more prevalent in women. J Stroke Cerebrovasc Dis. 2024 May;33(5):107646. doi: 10.1016/j.jstrokecerebrovasdis.2024.107646. Epub 2024 Feb 22.
PubMed 38395097El Husseini N, Goldstein LB, Peterson ED, Zhao X, Olson DM, Williams JW Jr, Bushnell C, Laskowitz DT. Depression Status Is Associated with Functional Decline Over 1-Year Following Acute Stroke. J Stroke Cerebrovasc Dis. 2017 Jul;26(7):1393-1399. doi: 10.1016/j.jstrokecerebrovasdis.2017.03.026. Epub 2017 Apr 25.
PubMed 28389192Redmond C, Bushnell C, Duncan P, D'Agostino R Jr, Ambrosius WT, Bishop L, Gesell S, Prvu-Bettger J, El Husseini N. Association of in-hospital depression and anxiety symptoms following stroke with 3 months- depression, anxiety and functional outcome. J Clin Neurosci. 2022 Apr;98:133-136. doi: 10.1016/j.jocn.2022.02.010. Epub 2022 Feb 15.
PubMed 35180502El Husseini N, Goldstein LB, Peterson ED, Zhao X, Pan W, Olson DM, Zimmer LO, Williams JW Jr, Bushnell C, Laskowitz DT. Depression and antidepressant use after stroke and transient ischemic attack. Stroke. 2012 Jun;43(6):1609-16. doi: 10.1161/STROKEAHA.111.643130. Epub 2012 Mar 29.
PubMed 22461330Schottke H, Giabbiconi CM. Post-stroke depression and post-stroke anxiety: prevalence and predictors. Int Psychogeriatr. 2015 Nov;27(11):1805-12. doi: 10.1017/S1041610215000988. Epub 2015 Jul 16.
PubMed 26178418Xu J, Zhou Y, Yan C, Wang X, Lou J, Luo Y, Gao S, Wang J, Wu L, Gao X, Shao A. Neurosteroids: A novel promise for the treatment of stroke and post-stroke complications. J Neurochem. 2022 Jan;160(1):113-127. doi: 10.1111/jnc.15503. Epub 2021 Sep 21.
PubMed 34482541Ishrat T, Sayeed I, Atif F, Hua F, Stein DG. Progesterone and allopregnanolone attenuate blood-brain barrier dysfunction following permanent focal ischemia by regulating the expression of matrix metalloproteinases. Exp Neurol. 2010 Nov;226(1):183-90. doi: 10.1016/j.expneurol.2010.08.023. Epub 2010 Sep 15.
PubMed 20816826
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allopregnanolone (Zuranolone) in Post-stroke Depression
- ClinicalTrials.gov ID
- NCT06759558
- Acronym / sponsor ID
- ALLO in PSD / Pro00118406
- Conditions
- Post Stroke Depression
- Keywords
- zuranolone, post stroke depression, allopregnanolone, stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jan 2025 (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.
The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are:
- Is zuranolone safe to take by participants who have moderate to severe post-stroke depression?
- Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression?
- Does zuranolone treat moderate to severe post-stroke depression?
The study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days.
Participants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zuranolone | Experimental | Drug: ZuranoloneParticipants in the Zuranolone arm will be treated for post-stroke depression for 14 days with 50mg of zuranolone once daily. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 21-65 years old of any sex and race/ethnicity
- Clinical ischemic or hemorrhagic acute stroke (confirmed by CT or MRI) occurring within 1 year of date of enrollment
- Moderate to severe PSD (Post-Stroke Depression) defined as having depressive symptoms lasting for at least 2 weeks and scoring 17 or more on the HAM-D (Hamilton Depression Rating Scale)
Key exclusion criteria (8 listed)
- Have abused or been dependent on narcotics, recreational drug use, or alcohol
- Advanced liver or kidney problems
- Pregnant or plan to become pregnant
- Post-partum period or breastfeeding
- History of attempted suicide
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 |
|---|---|---|
| ZuranoloneZuranolone is a neuroactive steroid that works by modulating the activity of the gamma-aminobutyric acid (GABA) receptor in the brain. | Drug | Zuranolone |
Primary outcome
Number of participants with treatment emergent adverse events (TEAEs) after starting zuranolone
Time frame: 90 days
TEAEs: suicidality and signs of abuse/dependence such as suicidal thinking and associated behaviors, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania, psychosis, worsening depression. Other TEAEs include: dizziness, somnolence, significant drowsiness causing impairment of daily activity, skin rash, abdominal pain, diarrhea, urinary tract infection, fatigue, memory impairment, tremor, muscle twitching, myalgia, headache, hypoesthesia, recurrent stroke, hypertension, hypotension, falls, confusion.
Severity of suicidal ideation after starting zuranolone as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 90 Days
The C-SSRS will be used to evaluate the intensity of suicidal ideation. The score ranges from 2 to 25, where a higher score indicates greater ideation.
Severity of somnolence after starting zuranolone as measured by the Epworth Sleepiness Scale (ESS)
Time frame: 90 Days
The ESS will be used to evaluate the intensity of somnolence. The score ranges from 0 to 24, where a score from 11-24 indicates excessive daytime sleepiness.
4 secondary outcomes
Change from baseline in Hamilton Depression Rating Scale (HAM-D) score at days 15 and 90
Time frame: Baseline, 15 days, 90 days
Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at days 15 and 90
Time frame: Baseline, 15 days, 90 days
Number of participants with HAM-D response at 3, 15, and 90 days
Time frame: 3 days, 15 days, 90 days
Number of participants with HAM-D remission (score ≤7) rates at 3, 15, and 90 days
Time frame: 3 days, 15 days, 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 38292895Wang S, Zhang W, Liu Z, Zhang T, Wang Y, Li W. Efficacy and safety of zuranolone in the treatment of major depressive disorder: a meta-analysis. Front Neurosci. 2024 Jan 16;17:1332329. doi: 10.3389/fnins.2023.1332329. eCollection 2023.
- Background: PubMed 37132201Clayton AH, Lasser R, Parikh SV, Iosifescu DV, Jung J, Kotecha M, Forrestal F, Jonas J, Kanes SJ, Doherty J. Zuranolone for the Treatment of Adults With Major Depressive Disorder: A Randomized, Placebo-Controlled Phase 3 Trial. Am J Psychiatry. 2023 Sep 1;180(9):676-684. doi: 10.1176/appi.ajp.20220459. Epub 2023 May 3.
- Background: PubMed 34190962Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):951-959. doi: 10.1001/jamapsychiatry.2021.1559.
- Background: PubMed 23348009Sripada RK, Marx CE, King AP, Rampton JC, Ho SS, Liberzon I. Allopregnanolone elevations following pregnenolone administration are associated with enhanced activation of emotion regulation neurocircuits. Biol Psychiatry. 2013 Jun 1;73(11):1045-53. doi: 10.1016/j.biopsych.2012.12.008. Epub 2013 Jan 21.
- Background: PubMed 34019980Chen S, Gao L, Li X, Ye Y. Allopregnanolone in mood disorders: Mechanism and therapeutic development. Pharmacol Res. 2021 Jul;169:105682. doi: 10.1016/j.phrs.2021.105682. Epub 2021 May 18.
- Background: PubMed 35558166Pinna G, Almeida FB, Davis JM. Allopregnanolone in Postpartum Depression. Front Glob Womens Health. 2022 Apr 26;3:823616. doi: 10.3389/fgwh.2022.823616. eCollection 2022.
- Background: PubMed 34189791Diviccaro S, Cioffi L, Falvo E, Giatti S, Melcangi RC. Allopregnanolone: An overview on its synthesis and effects. J Neuroendocrinol. 2022 Feb;34(2):e12996. doi: 10.1111/jne.12996. Epub 2021 Jun 29.
- Background: PubMed 32632771Chen S, Wang T, Yao J, Brinton RD. Allopregnanolone Promotes Neuronal and Oligodendrocyte Differentiation In Vitro and In Vivo: Therapeutic Implication for Alzheimer's Disease. Neurotherapeutics. 2020 Oct;17(4):1813-1824. doi: 10.1007/s13311-020-00874-x.
- Background: PubMed 38395097Dymm B, Goldstein LB, Unnithan S, Al-Khalidi HR, Koltai D, Bushnell C, Husseini NE. Depression following small vessel stroke is common and more prevalent in women. J Stroke Cerebrovasc Dis. 2024 May;33(5):107646. doi: 10.1016/j.jstrokecerebrovasdis.2024.107646. Epub 2024 Feb 22.
- Background: PubMed 28389192El Husseini N, Goldstein LB, Peterson ED, Zhao X, Olson DM, Williams JW Jr, Bushnell C, Laskowitz DT. Depression Status Is Associated with Functional Decline Over 1-Year Following Acute Stroke. J Stroke Cerebrovasc Dis. 2017 Jul;26(7):1393-1399. doi: 10.1016/j.jstrokecerebrovasdis.2017.03.026. Epub 2017 Apr 25.
- Background: PubMed 35180502Redmond C, Bushnell C, Duncan P, D'Agostino R Jr, Ambrosius WT, Bishop L, Gesell S, Prvu-Bettger J, El Husseini N. Association of in-hospital depression and anxiety symptoms following stroke with 3 months- depression, anxiety and functional outcome. J Clin Neurosci. 2022 Apr;98:133-136. doi: 10.1016/j.jocn.2022.02.010. Epub 2022 Feb 15.
- Background: PubMed 22461330El Husseini N, Goldstein LB, Peterson ED, Zhao X, Pan W, Olson DM, Zimmer LO, Williams JW Jr, Bushnell C, Laskowitz DT. Depression and antidepressant use after stroke and transient ischemic attack. Stroke. 2012 Jun;43(6):1609-16. doi: 10.1161/STROKEAHA.111.643130. Epub 2012 Mar 29.
- Individual participant dataSharing planned: No. Data will be shared via publications and/or presentations
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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.
Nada El Husseini, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zuranolone in people with Post Stroke Depression, run by Duke University at 1 site 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheila Joshi (919-684-1992, DepressionAfterStroke@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment emergent adverse events (TEAEs) after starting zuranolone (time frame: 90 days). The study lists 3 primary outcomes in all. 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 NCT06759558, which also lists 30 linked publications.
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 3 Sep 2026.