Duchenne / Becker Muscular DystrophyTAMDYNCT07101185
Transition to Adulthood in People With Muscular Dystrophy
A study testing VIRTUAL REALITY in people with Duchenne / Becker Muscular Dystrophy, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The study will involve boys with Duchenne Muscular Dystrophy (DMD), from adolescence to adulthood living in Italy, and their families/ caregivers. The Investigators want to explore patients' mental health, social cognition and perception of body image as well as patients'and caregivers' ability to adapt to changes… Read more about this study
- Who is it for?
- Ages 14 years and older, men only
- Conditions the study is for
- Duchenne / Becker Muscular Dystrophy
- What is being tested?
- VIRTUAL REALITY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2025to Aug 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 14 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Defined diagnosis of DMD
- Age > 14 years
- Willingness and ability to comply to study procedures
- Comprehension of the study and Signature of the informed consent
Who cannot join
- Clinical history of cerebral palsy, severe intellectual deficit, severe behavioral disturbances
- absence of compliance to the studyof the patient and the caregivers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Unit of Rare Disease- Rehabilitation Dept
Bosisio Parini, Lecco, 23842
Maria Grazia D'Angelo, 031877870, grazia.dangelo@lanostrafamiglia.it
About this study
Official title: Transition to Adulthood in People With Dystrophy: Social Cognition Mechanisms, Psychosocial Adjustment, and Mental Health and Coping Strategies.
The study will involve boys with Duchenne Muscular Dystrophy (DMD), from adolescence to adulthood living in Italy, and their families/ caregivers.
The Investigators want to explore patients' mental health, social cognition and perception of body image as well as patients'and caregivers' ability to adapt to changes related to both the disease and various personal and social needs, through the use of short and simple questionnaires, neuropsychological tests and neurocognitive evaluation in ecological scenarios using Virtual Reality. The desire for autonomy and the awareness of both personal and social difficulties in achieving them put a strain on both patients and their families.Some studies conducted in the USA and in various European countries underline that the transition to adulthood of patients with muscular dystrophy is featured by a good ability to adapt to the more advanced stages of the disease in general; nevertheless, facing the worsening of health entails experiences of anxiety and depression.In this historical phase, clinical trials of gene therapy and gene modulating therapies are involving an increasing number of patients, mainly represented by children in the early phase of the disease. Hence, adolescents and young adults could develop feelings of exclusion from research efforts, losing confidence and hope in any future improvement of their condition, social participation and quality of life.This study could lead to identify strengths and weaknesses in social cognition and psychosocial adaptation; through the evaluation of characteristics of patients/caregivers or exogenous factors influencing higher levels of social adaptation, we ultimately aim to define strategies to improve not only physical (already defined by guidelines) but also psychological care, social cognition and social support in all stages of DMD, particularly in later ones.
Read the detailed description
In recent decades, various scientific studies have demonstrated the effectiveness of non-invasiveventilation therapy, steroid therapy and in the early setting of cardiologic therapy with the result of lengthening the life expectancy of DMD patients up to 30-40 years and more.These recent improvements in care open up new questions relating, on one hand, to the management of typical problems of adulthood such as independence, leaving the family of origin and the management of new health problems (physical and psychological), and, on other hand, the necessary acceptance that, despite the advances in research in the therapeutic field, at the moment most of older patients (or simply wheelchair bound ones) have no access or very low possibility to access to either experimental therapies or innovative treatments.The Investigators hypothesize from their clinical experience and from the few data reported in the literature that a more severe clinical involvement may be related in some patients, to an increase in anxiety and depression meanwhile in others the Investigators are witnessing a strengthening of life planning.Some preliminary activities aimed at improving the multidisciplinary care in the late stages of the disease have been suggested for DMD, but the Investigators are mainly focused on body care (cardiac, respiratory, anaesthetic, gastrointestinal, bone health care) (Quinlivan R 2021), whereas limited evidence has been collected and very few interventions have been implemented in the psychosocial sphere.In the Investigators' opinion, an exploration of the psychosocial adjustment, social cognition, coping strategies, body image and mental health in a wide population of Italian adolescents and young adults with DMD and their families is mandatory, with the aim to identify strengths and weaknesses in psychosocial adaptation and social cognition and to define possible ways of improving not only the physical (which is defined and revised in dedicated guidelines) but also the psychosocial care. According to the transactional stress and coping model, parents who cope with their children's condition through acceptance of the reality-rather than denial of it-and positive reinterpretation of the experience (e.g., finding of opportunities for growth), could have a better emotional regulation in the long term, with a positive influence on children's emotional well-being and mental health. Research is needed in teenagers and adults to evaluate the possibility to establish, reinforce and sustain the same virtuous cycle in the whole population of patients.Invetigators believe that interventions aimed at developing individual resilience may help to foster the well-being of persons with neuromuscular disorders and protect them from later severe psychopathology.
From clinical experience and from few studies reported in literature (Magliano 2013, Aho 2015, Gagliardi 1991, Pater 2023), each patients' response to potential stressors may be different and change over time suggesting different levels of psychosocial adaptation and coping strategies.The Investigators hypothesize to identify groups of patients with higher levels of psychosocial adaptation (and potentially lower risk of developing psychopathology), the analysis of the characteristics of these subjects and the identification of the factors playing a role in this positive attitude may be useful to define which personal and relational resources need to be supported or developed to improve quality of life; this could allow also prompts discussion with territorial authorities for greater consideration of these families and their needs (employment opportunities, accessible working spaces, recreational opportunities, etc.).
OBJECTIVES: The study therefore aims to:1) assess psychosocial adjustment, mental health and coping strategies through standardized measures in a large population of teenagers and adults with DMD and their caregivers;2) test social cognition mechanisms with standardized neuropsychological evaluation and newly-developed cognitive neuroscience paradigms that investigate emotional and social processing in ecological settings using Virtual reality in a subsample of patients;3) explore the body image perception and assess its impact on psychological well-being exploring the role of cognitive and motor impairment as possible mediators 4) investigate the interaction patterns between medical conditions, social cognition, psychosocial adjustment, mental health and coping strategies, in order to identify strengths to be supported and weaknesses to be reduced or counterbalanced. The project will ultimately pave the way for future development of cognitive and psychosocial interventions for improving psychosocial functioning and quality of life of the partecipants
- Conditions
- Duchenne / Becker Muscular Dystrophy
- Being tested
- VIRTUAL REALITY
- Keywords
- Duchenne muscular dystrophy, transition to adulthood,, social cognition, psychosocial adjustment, mental health and coping strategies
- Medical subject headings
- Muscular Dystrophy, Duchenne, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIRTUAL REALITYDevice
The interventional part of the study is limited to 3 centers. It explores SOCIAL COGNITION throught a newly developed paradigm in Virtual Reality.
In detail: an adapted version of the Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) using a VR Head Mounted Display (HMD) will be implemented on a portable HMD, the Oculus Quest, equipped with two controllers with motion sensors that are used to track hand position.
In a VR-SPIRIT session, participants are immersed in the playground scenario and engaged in a competition with four avatars. Each avatar has a pre-established probability to move toward one of the three described games.
Different indices about a partecipant's performance are recorded automatically by the system during the session, such as the duration of each trial and the prediction score (percentage of trials in which the participant correctly predicted an avatar's intention).
| Study group | Role | What they receive |
|---|---|---|
| one arm | Experimental | SOCIAL COGNITION- VIRTUAL REALITY Receives: Device: VIRTUAL REALITY |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychosocial adjustment, mental health and coping strategies
To assess psychosocial adjustment, mental health and coping strategies through standardized measures in a large population of teenagers and adults with DMD and their caregivers
Measured: baseline visit
social cognition
To test social cognition mechanisms with standardized neuropsychological evaluation and newly-developed cognitive neuroscience paradigms that investigate emotional and social processing in ecological settings using Virtual reality in a subsample of partecipants
Measured: baseline visit
body image
To explore body image perception and assess its impact on psychological well-being exploring the role of cognitive and motor impairment as possible mediators
Measured: baseline visit
Correlation with medical conditions
To investigate the interaction patterns between medical conditions and test on social cognition, psychosocial adjustment, mental health and coping strategies, to identify strengths to be supported and weaknesses to be reduced or counterbalanced.
Measured: baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duchenne / Becker Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Standardized neuropsychological measures of Theory of Mind will be also administered. The Virtual Reality (VR) scenario will be used to measure social cognition abilities in a subsample of 40 patients recruited at the centers of the Scientific Institute E. Medea in Bosisio and in Brindisi and at the Fondazione Mondino in Pavia, which have equipment and know-how for VR applications.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova, IRCCS National Neurological Institute "C. Mondino" Foundation, Istituto Giannina Gaslini - IRCCS, Fondazione Serena Onlus - Centro Clinico NeMO Milano, Centro Clinico NeMO Ancona, IRCCS Fondazione Stella Maris, Università degli Studi di Milano Statale, Centro Clinico NeMO Brescia, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, I.R.C.C.S. Eugenio Medea - Associazione La Nostra Famiglia - Sede di Conegliano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Dipartimento di Neuroscienze Rita Levi Montalcini Torino, Università Vita-Salute San Raffaele, Università di Pisa, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Associazione La Nostra Famiglia Eugenio Medea - Brindisi, Scientific Institute, IRCCS E.Medea, Pasian di Prato, IRCCS Istituto delle Scienze Neurologiche di Bologna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101185
- Sponsor's protocol ID
- Medea 152/24
- Acronym
- TAMDY
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanzo' S, Tizzoni F, Previtali SC, Berardinelli A, Nobile M, Molteni M, Manzoni M, Tarabelloni A, Russo A, Delle Fave A, D'Angelo MG. Psychosocial resources and psychopathology among persons with neuromuscular disorders during the COVID-19 pandemic. BMC Psychol. 2024 Apr 29;12(1):243. doi: 10.1186/s40359-024-01742-5.
PubMed 38685111
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition to Adulthood in People With Dystrophy: Social Cognition Mechanisms, Psychosocial Adjustment, and Mental Health and Coping Strategies.
- ClinicalTrials.gov ID
- NCT07101185
- Acronym / sponsor ID
- TAMDY / Medea 152/24
- Conditions
- Duchenne / Becker Muscular Dystrophy
- Keywords
- Duchenne muscular dystrophy, transition to adulthood,, social cognition, psychosocial adjustment, mental health and coping strategies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- University of Padova, IRCCS National Neurological Institute "C. Mondino" Foundation, Istituto Giannina Gaslini - IRCCS, Fondazione Serena Onlus - Centro Clinico NeMO Milano, Centro Clinico NeMO Ancona, IRCCS Fondazione Stella Maris, Università degli Studi di Milano Statale, Centro Clinico NeMO Brescia, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, I.R.C.C.S. Eugenio Medea - Associazione La Nostra Famiglia - Sede di Conegliano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Dipartimento di Neuroscienze Rita Levi Montalcini Torino, Università Vita-Salute San Raffaele, Università di Pisa, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Associazione La Nostra Famiglia Eugenio Medea - Brindisi, Scientific Institute, IRCCS E.Medea, Pasian di Prato, IRCCS Istituto delle Scienze Neurologiche di Bologna
- Study start
- Sep 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Aug 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 study will involve boys with Duchenne Muscular Dystrophy (DMD), from adolescence to adulthood living in Italy, and their families/ caregivers.
The Investigators want to explore patients' mental health, social cognition and perception of body image as well as patients'and caregivers' ability to adapt to changes related to both the disease and various personal and social needs, through the use of short and simple questionnaires, neuropsychological tests and neurocognitive evaluation in ecological scenarios using Virtual Reality. The desire for autonomy and the awareness of both personal and social difficulties in achieving them put a strain on both patients and their families.Some studies conducted in the USA and in various European countries underline that the transition to adulthood of patients with muscular dystrophy is featured by a good ability to adapt to the more advanced stages of the disease in general; nevertheless, facing the worsening of health entails experiences of anxiety and depression.In this historical phase, clinical trials of gene therapy and gene modulating therapies are involving an increasing number of patients, mainly represented by children in the early phase of the disease. Hence, adolescents and young adults could develop feelings of exclusion from research efforts, losing confidence and hope in any future improvement of their condition, social participation and quality of life.This study could lead to identify strengths and weaknesses in social cognition and psychosocial adaptation; through the evaluation of characteristics of patients/caregivers or exogenous factors influencing higher levels of social adaptation, we ultimately aim to define strategies to improve not only physical (already defined by guidelines) but also psychological care, social cognition and social support in all stages of DMD, particularly in later ones.
Detailed description
In recent decades, various scientific studies have demonstrated the effectiveness of non-invasiveventilation therapy, steroid therapy and in the early setting of cardiologic therapy with the result of lengthening the life expectancy of DMD patients up to 30-40 years and more.These recent improvements in care open up new questions relating, on one hand, to the management of typical problems of adulthood such as independence, leaving the family of origin and the management of new health problems (physical and psychological), and, on other hand, the necessary acceptance that, despite the advances in research in the therapeutic field, at the moment most of older patients (or simply wheelchair bound ones) have no access or very low possibility to access to either experimental therapies or innovative treatments.The Investigators hypothesize from their clinical experience and from the few data reported in the literature that a more severe clinical involvement may be related in some patients, to an increase in anxiety and depression meanwhile in others the Investigators are witnessing a strengthening of life planning.Some preliminary activities aimed at improving the multidisciplinary care in the late stages of the disease have been suggested for DMD, but the Investigators are mainly focused on body care (cardiac, respiratory, anaesthetic, gastrointestinal, bone health care) (Quinlivan R 2021), whereas limited evidence has been collected and very few interventions have been implemented in the psychosocial sphere.In the Investigators' opinion, an exploration of the psychosocial adjustment, social cognition, coping strategies, body image and mental health in a wide population of Italian adolescents and young adults with DMD and their families is mandatory, with the aim to identify strengths and weaknesses in psychosocial adaptation and social cognition and to define possible ways of improving not only the physical (which is defined and revised in dedicated guidelines) but also the psychosocial care. According to the transactional stress and coping model, parents who cope with their children's condition through acceptance of the reality-rather than denial of it-and positive reinterpretation of the experience (e.g., finding of opportunities for growth), could have a better emotional regulation in the long term, with a positive influence on children's emotional well-being and mental health. Research is needed in teenagers and adults to evaluate the possibility to establish, reinforce and sustain the same virtuous cycle in the whole population of patients.Invetigators believe that interventions aimed at developing individual resilience may help to foster the well-being of persons with neuromuscular disorders and protect them from later severe psychopathology.
From clinical experience and from few studies reported in literature (Magliano 2013, Aho 2015, Gagliardi 1991, Pater 2023), each patients' response to potential stressors may be different and change over time suggesting different levels of psychosocial adaptation and coping strategies.The Investigators hypothesize to identify groups of patients with higher levels of psychosocial adaptation (and potentially lower risk of developing psychopathology), the analysis of the characteristics of these subjects and the identification of the factors playing a role in this positive attitude may be useful to define which personal and relational resources need to be supported or developed to improve quality of life; this could allow also prompts discussion with territorial authorities for greater consideration of these families and their needs (employment opportunities, accessible working spaces, recreational opportunities, etc.).
OBJECTIVES: The study therefore aims to:1) assess psychosocial adjustment, mental health and coping strategies through standardized measures in a large population of teenagers and adults with DMD and their caregivers;2) test social cognition mechanisms with standardized neuropsychological evaluation and newly-developed cognitive neuroscience paradigms that investigate emotional and social processing in ecological settings using Virtual reality in a subsample of patients;3) explore the body image perception and assess its impact on psychological well-being exploring the role of cognitive and motor impairment as possible mediators 4) investigate the interaction patterns between medical conditions, social cognition, psychosocial adjustment, mental health and coping strategies, in order to identify strengths to be supported and weaknesses to be reduced or counterbalanced. The project will ultimately pave the way for future development of cognitive and psychosocial interventions for improving psychosocial functioning and quality of life of the partecipants
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Standardized neuropsychological measures of Theory of Mind will be also administered. The Virtual Reality (VR) scenario will be used to measure social cognition abilities in a subsample of 40 patients recruited at the centers of the Scientific Institute E. Medea in Bosisio and in Brindisi and at the Fondazione Mondino in Pavia, which have equipment and know-how for VR applications.
| Arm | Type | Receives |
|---|---|---|
| one arm | Experimental | Device: VIRTUAL REALITYSOCIAL COGNITION- VIRTUAL REALITY |
Who may qualify
- Ages
- 14 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Defined diagnosis of DMD
- Age > 14 years
- Willingness and ability to comply to study procedures
- Comprehension of the study and Signature of the informed consent
Key exclusion criteria (2 listed)
- Clinical history of cerebral palsy, severe intellectual deficit, severe behavioral disturbances
- absence of compliance to the studyof the patient and the caregivers.
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 |
|---|---|---|
| VIRTUAL REALITYThe interventional part of the study is limited to 3 centers. It explores SOCIAL COGNITION throught a newly developed paradigm in Virtual Reality. In detail: an adapted version of the Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) using a VR Head Mounted Display (HMD) will be implemented on a portable HMD, the Oculus Quest, equipped with two controllers with motion sensors that are used to track hand position. In a VR-SPIRIT session, participants are immersed in the playground scenario and engaged in a competition with four avatars. Each avatar has a pre-established probability to move toward one of the three described games. Different indices about a partecipant's performance are recorded automatically by the system during the session, such as the duration of each trial and the prediction score (percentage of trials in which the participant correctly predicted an avatar's intention). | Device | one arm |
Primary outcome
psychosocial adjustment, mental health and coping strategies
Time frame: baseline visit
To assess psychosocial adjustment, mental health and coping strategies through standardized measures in a large population of teenagers and adults with DMD and their caregivers
social cognition
Time frame: baseline visit
To test social cognition mechanisms with standardized neuropsychological evaluation and newly-developed cognitive neuroscience paradigms that investigate emotional and social processing in ecological settings using Virtual reality in a subsample of partecipants
body image
Time frame: baseline visit
To explore body image perception and assess its impact on psychological well-being exploring the role of cognitive and motor impairment as possible mediators
Correlation with medical conditions
Time frame: baseline visit
To investigate the interaction patterns between medical conditions and test on social cognition, psychosocial adjustment, mental health and coping strategies, to identify strengths to be supported and weaknesses to be reduced or counterbalanced.
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 Aug 2025.
- Results publication: PubMed 38685111Sanzo' S, Tizzoni F, Previtali SC, Berardinelli A, Nobile M, Molteni M, Manzoni M, Tarabelloni A, Russo A, Delle Fave A, D'Angelo MG. Psychosocial resources and psychopathology among persons with neuromuscular disorders during the COVID-19 pandemic. BMC Psychol. 2024 Apr 29;12(1):243. doi: 10.1186/s40359-024-01742-5.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIRTUAL REALITY in people with Duchenne / Becker Muscular Dystrophy, run by IRCCS Eugenio Medea at 1 site in Italy.
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 2 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: opening soon, as of the sponsor's last update on 3 Aug 2025. 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 Italy. 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 Maria Grazia N D'Angelo, MD PhD (+39 031877870, grazia.dangelo@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychosocial adjustment, mental health and coping strategies (time frame: baseline visit). The study lists 4 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 NCT07101185, 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 3 Aug 2025.