AphasiaNCT06368323
Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia
A study testing Choir singing in people with Aphasia, run by University of Ottawa at 4 sites in 2 countries.
Trial summary
The goal of this randomized controled trial is to test the effects of assigning people with chronic post-stroke aphasia to 12 weekly choir sessions, compared to usual care. The main question it aims to answer is: Does the assignment to a choir singing program causes a beneficial effect on functional communication and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia
- What is being tested?
- Choir singing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 22 Apr 2024to 30 Sep 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with chronic aphasia following stroke
- English or French as language of daily use
- Last stroke must have occurred at least 6 months before the start of the first assessments in the study protocol.
Who cannot join
- Regular music making in the past 6 months
- Visual deficit that cannot be corrected and might impair testing
- Hearing deficit that cannot be corrected and might impair testing
- Presence of neurological/psychiatric co-morbidity or substance abuse
- No ability to produce vocal sound through singing/humming
- Legally considered unable to make decisions for oneself
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Canada3 sites, 1 recruiting
- Completed
Université de Montréal
Montreal, Quebec, H3C 3J7
- Completed
University of Ottawa
Ottawa, Ontario, K1N 6N5
- Recruiting
Toronto Metropolitan University
Toronto, Ontario, M5B 0C3
Arla Good, Ph.D., arla.good@torontomu.ca
United States1 site, 1 recruiting
- Not yet recruiting
University of South Florida
Tampa, Florida, 33620
Jennifer Bugos, Ph.D., bugosj@usf.edu
About this study
The goal of this randomized controled trial is to test the effects of assigning people with chronic post-stroke aphasia to 12 weekly choir sessions, compared to usual care.
The main question it aims to answer is:
Does the assignment to a choir singing program causes a beneficial effect on functional communication and language recovery as well as psychosocial outcomes compared to usual care in the rehabilitation of people with chronic post-stroke aphasia?
Participants will have:
12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master, and home singing training (3 x 30-minutes-sessions/week, total 18h)
Read the detailed description
Description of study population Additional information: Participants with chronic aphasia due to stroke will be recruited from four participating centers in Canada and the United States.
Study design Additional information: A parallel group randomized trial design with a secondary crossover extension was chosen for this study to offer the intervention to all participants. Participants will be randomized in a 1:1 ratio to two study arms (AB/BA, A = 12 weekly choir sessions and home singing training, B = usual care) stratified for aphasia severity (according to the Quick Aphasia Battery overall score), age, time since last stroke and their interest in music (according to the Barcelona Music Reward Questionnaire). Measures at the "macro" level will be collected at Baseline, Completion and 2-months Follow-up time points for each group. At the "micro" level (i.e., at choir sessions 2, 6, 10 and 12) data will be collected during as well as pre and post choir-singing.
Intervention Additional information: The repertoire in the comunity choir activity will consist of popular songs in English or French. Half of the songs will be pre-determined and half will be chosen by the choir members from a list, based on a vote during the first week of the intervention. Eligible songs will remain within the range of an octave and include a variety of tempi (but fast tempi will be slowed down if needed to facilitate word production). Depending on the group's abilities, the Choir Director will decide in which keys the songs will be performed, and whether they will be sung in unison or with simple harmonies. Songs in canon will be included in the predetermined repertoire to easily create harmonies. Each session will include (in this order): 15 minutes for vocal warm-up; 25 minutes of work on the song repertoire; 20 minutes for a social break with refreshments.
For the home training, participants will be instructed to sing at home with a video guide on an online platform. Each home training session will include (in this order): 10 minutes for vocal warm-up; and 20 minutes sing-along using songs of the repertoire. Song lyrics will be displayed on the video.
To monitor the usual care, each participant (and/or caregiver) will complete a form and/or have a weekly 5-15-minute phone/Zoom call with a research assistant to collect the usual care data including type and time spent in social activities and rehabilitation services, as well as adverse events.
Randomization and concealment For randomization, an online system will be used by a researcher not involved in data collection.
Each participant will be assigned an identification number upon inclusion in the study. After completion of the baseline assessments, the independent researcher will receive the list of participants' IDs with their stratification data (age, time post-stoke, aphasia severity, level of interest in music) to perform the randomization.
Blinding:
Outcomes will be measured by blinded assessors where possible, based on video or audio recordings.
Planned analyses:
Primary hypothesis:
Participants assigned to the choir intervention over 12 weeks will demonstrate a significantly larger improvement in macro-level measures compared to those receiving usual care.
Secondary hypothesis:
Participants who completed the choir intervention with 80% adherence over 12 weeks will demonstrate a larger improvement in macro-level measures compared to those receiving usual care.
The gains will be maintained for the participants with 80% adherence.
There will be immediate changes in micro-level measures after a choir session (Session 6).
There will be differences in pre-post-session variations of micro-level measures between Session 2, 6 and 10.
There will be differences in pre-post-session variations between the usual rehearsal (Session 10) and the Concert (Session 12).
- Conditions
- Aphasia
- Being tested
- Choir singing, Usual care
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choir singingBehavioural
The 12-week intervention will consist of 12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master in addition to home training (3 x 30-minutes-sessions/week, total 18h). In total, participants will undergo the intervention for 3 hours/week for 12 weeks (i.e., 36 hours).
Usual careOther
Rehabilitation services received by patients and social activities will be monitored and documented.
| Study group | Role | What they receive |
|---|---|---|
| AB Group | Experimental | First choir, then usual care Receives: Behavioral: Choir singing; Other: Usual care |
| BA Group | Experimental | First usual care, then choir Receives: Behavioral: Choir singing; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication Index
The ability to communicate one's feelings and basic needs effectively / is computed by averaging the percentage scores (score/total×100) of the Communicative Activity Log (CAL) and the communication subscale of the Stroke Impact Scale 3.0 (SIS).
Minimum value=0; Maximum value=100; Higher scores mean a better outcome.
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Secondary outcomes (10)
Level of confidence in communication
Individual's subjective perception of their ability to effectively communicate in various situations / assessed with the Communication Confidence Rating Scale for Aphasia (CCRSA), a self-reported assessment in 10 questions.
Minimum value=4; Maximum value=40; Higher scores mean a better outcome.
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Aphasia severity index
The aphasia severity index quantifies the extent of language impairment experienced by individuals with aphasia / assessed using the Quick Aphasia Battery (QAB).
Minimum value=0; Maximum value=10; Higher scores mean a better outcome.
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Speech and language in functional communication
The ability of an individual to effectively use verbal communication skills / assessed with a part of the AphasiaBank protocol to elicit connected speech in participants Minimum value=0; Maximum value=100; Higher scores mean a better outcome.
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Apraxia of speech severity
The degree or level of impairment in the motor planning and execution of speech movements / assessed with the Apraxia of Speech Rating Scale (ASRS-3.5) experienced by individuals with apraxia Minimum value=0; Maximum value=52; Higher scores mean a worse outcome.
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
Individual's subjective perception of their physical, emotional, mental, and social well-being in relation to their health status and the impact of illness or treatment on their overall quality of life / assessed with the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) Minimum value=39; Maximum value=195; Higher scores mean a better outcome.
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Emotional wellbeing
The state of an individual's mental and emotional health, encompassing their overall mood, psychological resilience, and ability to cope with stressors and life challenges / assessed using the General Health Questionnaire (GHQ-12) Minimum value=0; Maximum value=36; Higher scores mean a worse outcome.
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Social participation
Active engagement of individuals within their community or society, involving various social activities, interactions, and roles. / assessed using the corresponding SIS participation subscale.
Minimum value=8; Maximum value=40; Higher scores mean a better outcome.
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Generic measure of health
Short-Form 6-Dimension version 2 (SF-6Dv2) is a survey on 6 health domains: Physical functioning, Role functioning, Pain, Vitality, Social functioning, Mental health.
Minimum value= 0; Maximum value= 100;Higher scores mean a better outcome.
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Appetence to music
An individual's inclination or attraction towards music / Barcelona Music Reward Questionnaire (BMRQ)
Minimum value= 20; Maximum value= 100 ; Higher scores mean a better outcome.
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Singing voice abilities
Overall singing voice quality, tuning and rhythmic accuracy / assessed following a standardized protocol
Measured: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start22 Apr 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel group randomized trial design with a secondary crossover extension
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Metropolitan University, Université de Montréal, Université du Québec à Trois-Rivières, University of South Florida
- Responsible party
- Principal investigator, Anna Zumbansen, University of Ottawa
- Investigators
- Anna Zumbansen, PhD, Principal investigator, University of OttawaArla Good, PhD, Principal investigator, Toronto Metropolitan UniversityFrank Russo, PhD, Principal investigator, Toronto Metropolitan UniversityCarole Anglade, PhD, Principal investigator, Université de MontréalÉdith Durand, PhD, Principal investigator, Université du Québec à Trois-RivièresJennifer Bugos, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368323
- Sponsor's protocol ID
- H-01-24-9931
- Status last verified
- Feb 2026
- First submitted
- 1 Apr 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siponkoski ST, Pitkaniemi A, Laitinen S, Sarkamo ER, Pentikainen E, Eloranta H, Tuomiranta L, Melkas S, Schlaug G, Sihvonen AJ, Sarkamo T. Efficacy of a multicomponent singing intervention on communication and psychosocial functioning in chronic aphasia: a randomized controlled crossover trial. Brain Commun. 2022 Dec 27;5(1):fcac337. doi: 10.1093/braincomms/fcac337. eCollection 2023.
PubMed 36687394Anna Zumbansen, Isabelle Peretz, Carole Anglade, Josée Bilodeau, Suzanne Généreux, Michelyne Hubert & Sylvie Hébert (2017) Effect of choir activity in the rehabilitation of aphasia: a blind, randomised, controlled pilot study, Aphasiology, 31:8, 879-900, DOI: 10.1080/02687038.2016.1227424
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia
- ClinicalTrials.gov ID
- NCT06368323
- Acronym / sponsor ID
- H-01-24-9931
- Conditions
- Aphasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Toronto Metropolitan University, Université de Montréal, Université du Québec à Trois-Rivières, University of South Florida
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Apr 2024 (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 randomized controled trial is to test the effects of assigning people with chronic post-stroke aphasia to 12 weekly choir sessions, compared to usual care.
The main question it aims to answer is:
Does the assignment to a choir singing program causes a beneficial effect on functional communication and language recovery as well as psychosocial outcomes compared to usual care in the rehabilitation of people with chronic post-stroke aphasia?
Participants will have:
12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master, and home singing training (3 x 30-minutes-sessions/week, total 18h)
Detailed description
Description of study population Additional information: Participants with chronic aphasia due to stroke will be recruited from four participating centers in Canada and the United States.
Study design Additional information: A parallel group randomized trial design with a secondary crossover extension was chosen for this study to offer the intervention to all participants. Participants will be randomized in a 1:1 ratio to two study arms (AB/BA, A = 12 weekly choir sessions and home singing training, B = usual care) stratified for aphasia severity (according to the Quick Aphasia Battery overall score), age, time since last stroke and their interest in music (according to the Barcelona Music Reward Questionnaire). Measures at the "macro" level will be collected at Baseline, Completion and 2-months Follow-up time points for each group. At the "micro" level (i.e., at choir sessions 2, 6, 10 and 12) data will be collected during as well as pre and post choir-singing.
Intervention Additional information: The repertoire in the comunity choir activity will consist of popular songs in English or French. Half of the songs will be pre-determined and half will be chosen by the choir members from a list, based on a vote during the first week of the intervention. Eligible songs will remain within the range of an octave and include a variety of tempi (but fast tempi will be slowed down if needed to facilitate word production). Depending on the group's abilities, the Choir Director will decide in which keys the songs will be performed, and whether they will be sung in unison or with simple harmonies. Songs in canon will be included in the predetermined repertoire to easily create harmonies. Each session will include (in this order): 15 minutes for vocal warm-up; 25 minutes of work on the song repertoire; 20 minutes for a social break with refreshments.
For the home training, participants will be instructed to sing at home with a video guide on an online platform. Each home training session will include (in this order): 10 minutes for vocal warm-up; and 20 minutes sing-along using songs of the repertoire. Song lyrics will be displayed on the video.
To monitor the usual care, each participant (and/or caregiver) will complete a form and/or have a weekly 5-15-minute phone/Zoom call with a research assistant to collect the usual care data including type and time spent in social activities and rehabilitation services, as well as adverse events.
Randomization and concealment For randomization, an online system will be used by a researcher not involved in data collection.
Each participant will be assigned an identification number upon inclusion in the study. After completion of the baseline assessments, the independent researcher will receive the list of participants' IDs with their stratification data (age, time post-stoke, aphasia severity, level of interest in music) to perform the randomization.
Blinding:
Outcomes will be measured by blinded assessors where possible, based on video or audio recordings.
Planned analyses:
Primary hypothesis:
Participants assigned to the choir intervention over 12 weeks will demonstrate a significantly larger improvement in macro-level measures compared to those receiving usual care.
Secondary hypothesis:
Participants who completed the choir intervention with 80% adherence over 12 weeks will demonstrate a larger improvement in macro-level measures compared to those receiving usual care.
The gains will be maintained for the participants with 80% adherence.
There will be immediate changes in micro-level measures after a choir session (Session 6).
There will be differences in pre-post-session variations of micro-level measures between Session 2, 6 and 10.
There will be differences in pre-post-session variations between the usual rehearsal (Session 10) and the Concert (Session 12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel group randomized trial design with a secondary crossover extension
| Arm | Type | Receives |
|---|---|---|
| AB Group | Experimental | Behavioral: Choir singing, Other: Usual careFirst choir, then usual care |
| BA Group | Experimental | Behavioral: Choir singing, Other: Usual careFirst usual care, then choir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People with chronic aphasia following stroke
- English or French as language of daily use
- Last stroke must have occurred at least 6 months before the start of the first assessments in the study protocol.
Key exclusion criteria (6 listed)
- Regular music making in the past 6 months
- Visual deficit that cannot be corrected and might impair testing
- Hearing deficit that cannot be corrected and might impair testing
- Presence of neurological/psychiatric co-morbidity or substance abuse
- No ability to produce vocal sound through singing/humming
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 |
|---|---|---|
| Choir singingThe 12-week intervention will consist of 12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master in addition to home training (3 x 30-minutes-sessions/week, total 18h). In total, participants will undergo the intervention for 3 hours/week for 12 weeks (i.e., 36 hours). | Behavioural | AB Group, BA Group |
| Usual careRehabilitation services received by patients and social activities will be monitored and documented. | Other | AB Group, BA Group |
Primary outcome
Communication Index
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
The ability to communicate one's feelings and basic needs effectively / is computed by averaging the percentage scores (score/total×100) of the Communicative Activity Log (CAL) and the communication subscale of the Stroke Impact Scale 3.0 (SIS). Minimum value=0; Maximum value=100; Higher scores mean a better outcome.
10 secondary outcomes
Level of confidence in communication
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Aphasia severity index
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Speech and language in functional communication
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Apraxia of speech severity
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Emotional wellbeing
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Social participation
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Generic measure of health
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Appetence to music
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
Singing voice abilities
Time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)
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 17 Feb 2026.
- Background: PubMed 36687394Siponkoski ST, Pitkaniemi A, Laitinen S, Sarkamo ER, Pentikainen E, Eloranta H, Tuomiranta L, Melkas S, Schlaug G, Sihvonen AJ, Sarkamo T. Efficacy of a multicomponent singing intervention on communication and psychosocial functioning in chronic aphasia: a randomized controlled crossover trial. Brain Commun. 2022 Dec 27;5(1):fcac337. doi: 10.1093/braincomms/fcac337. eCollection 2023.
- BackgroundAnna Zumbansen, Isabelle Peretz, Carole Anglade, Josée Bilodeau, Suzanne Généreux, Michelyne Hubert & Sylvie Hébert (2017) Effect of choir activity in the rehabilitation of aphasia: a blind, randomised, controlled pilot study, Aphasiology, 31:8, 879-900, DOI: 10.1080/02687038.2016.1227424
- The SingWell ProjectLink provided by the sponsor.
- 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.
Anna Zumbansen, PhD principal investigator
University of Ottawa
Arla Good, PhD principal investigator
Toronto Metropolitan University
Frank Russo, PhD principal investigator
Toronto Metropolitan University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choir singing in people with Aphasia, run by University of Ottawa at 4 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 3 inclusion and 6 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, 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.
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 Anna Zumbansen, PhD (613-562-5800 ext. 8393, azumbans@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication Index (time frame: T1 (baseline, week 1), T2 (week 15), T3 (week 16), T4 (week 30), T5 (week 31)). 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 NCT06368323, which also lists 2 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 17 Feb 2026.