Neuromuscular DiseasesDT4RDNCT05798325
Feasibility, Validation and Application of Digital Tools for the Follow-up of Neuromuscular Patient Mobility in Daily Living
A study testing 2MWT, MFM32 and MyoGrip in people with Neuromuscular Diseases, run by Institut de Myologie, France at 2 sites in 2 countries.
Trial summary
The low prevalence of rare diseases hinders the design of clinical studies with sufficient statistical power to demonstrate the efficacy of new drugs. This can only be achieved by setting up international multicentre studies, which is challenging due to a lack of objective, universal outcome measures that generate… Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- 2MWT, MFM32 and MyoGrip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 29 Jun 2023to 6 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 12 and 60 years
- Patients with a genetically confirmed/molecular-proven neuromuscular or neurometabolic disease*
- Patients experiencing walking difficulties in the home and at high risk of limiting participation and walking outside of the home.
- Written informed consent
- Able to comply with all protocol requirements, including video recording
- Affiliated to or beneficiary of a social security scheme (for France)
Who cannot join
- Patients with undefined diagnosis or any diagnosis other than neuromuscular or neurometabolic disease
- Patient walking 10m in less than 10s
- Guardianship/trusteeship
- Pregnant or nursing women
- Patients having relevant concomitant pathologies that, in the appreciation of the investigator could interfere with protocol compliance
- Patients not being affiliated with local social security (for France)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
John Walton Muscular Dystrophy Research Centre
Newcastle upon Tyne, NE1 3BZ
About this study
Official title: Feasibility, Validation and Application of Digital Tools for the Follow-up of Neuromuscular Patient
The low prevalence of rare diseases hinders the design of clinical studies with sufficient statistical power to demonstrate the efficacy of new drugs. This can only be achieved by setting up international multicentre studies, which is challenging due to a lack of objective, universal outcome measures that generate high-quality, reproducible data. One of the hurdles in attaining universal outcome measures for clinical trials is the difficulty to capture and distinguish ambulatory from non-ambulatory, autonomous and assistive or involuntary movements. This makes a trial assessing the ambulatory phase very challenging at this moment. Excluding many participants from trials and many patients from access to medication.
Integration and validation of the technology in trials, research and patients' lives is essential in overcoming this hurdle. For example, in dystrophinopathies separate outcome measures exist for ambulant and non-ambulant participants, but the relation between these outcome measures or a transitional outcome measure/end point is largely missing.
Read more
Following an exhaustive literature review, several tools have been selected to remotely follow various symptoms of neuromuscular patients including weakness, pain, fatigue, cognitive defects, motor impairments (including loss of dexterity, ataxia...), metabolic, respiratory and cardiac troubles, contractures, tremor, falls, hypo or hypersomnia... The toolbox includes common measures for all patients but may include additional measures specific to the patient's symptoms (hence in turn to the patients' disease).
The measurements are designed to not be invasive, intrusive or burdensome for the patient.
DT4RD is going to leverage state-of-the art technology, clinical rating scales and psychometric/data analysis to deliver fit for purpose remote clinical assessments of mobility to ensure maximum patient benefit, specifically:
- Compare face to face clinical data collected in hospital with Patient Generated Data recorded remotely
- Examine how sensors can enhance measurement potentially at home and during clinical visits
- Promote a clear focus on user centered design and the integration of technology
- Use reliability and validity analyses to equate any common measures (those with the same or a similar construct)
- Demonstrate a proof-of-concept model into which different measures can be interchangeable
- Conditions
- Neuromuscular Diseases
- Being tested
- 2MWT, MFM32, MyoGrip, QOL-gNMD, Spirometry
- Keywords
- Neuromuscular Diseases, Dystrophy, Monitoring, Accelerometer, Evaluation
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2MWTOther
Also called Two minutes walk tests
Two minutes walk tests.
MFM32Other
Also called Muscle Motor Function 32
Motor Function Measurement (MFM) is a quantitative scale created to measure global motor functional abilities in a person with neuromuscular disease.
MyoGripOther
The MyoGrip is a dynamometer for measuring grip strength.
QOL-gNMDOther
The "Quality of Life in genetic Neuromuscular Disease" questionnaire (QoL-gNMD) is a patient reported outcome measure (PROM) tool specifically designed for patients with a lowly progressive neuromuscular disease with genetically predominant muscular damage
SpirometryDiagnostic test
Also called Spirobank Smart
Forced vital capacity (FVC), peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) will be measured in the hospital with the local hospital device (e.g. Vitalograph) under the supervision of the clinical evaluator, and at home with a portable device.
AcceleromertyDevice
Also called Links sensor system
The Links sensor system is a measuring device and consists of the Links Pods and the Links Hub. The Links pods contain an accelerometer, gyroscope and magnetometer to measure position relative to a global reference frame.
10mWTOther
10 meters walking Test.
PULOther
Also called Performance of Upper Limb
The Performance of the Upper Limb (PUL) is a functional scale specifically designed for assessing upper limb function in Duchenne muscular dystrophy.
NSAAOther
Also called North Star Ambulatory Assessment
The North Star Ambulatory Assessment (NSAA) is a 17-item rating scale that is used to measure functional motor abilities in ambulant children with Duchenne Muscular Dystrophy.
NSADOther
Also called North Star Assessment for limb-girdle type muscular dystrophies
The NSAD was developed to measure motor performance in ambulant and non-ambulant subjects as part of the clinical outcome study of dysferlinopathy.
TANSOther
Also called Transition Assessment North Star
This scale is derived from the North Star Ambulatory Assessment and several items from the Egan Klassifikation Scale (EK2).
MyoPinchOther
The MyoPinch is a high-precision dynamometer that allows the evaluation of key pinch strength.
MyoQuadOther
The MyoQuad is a high-precision dynamometer that allows the evaluation of knee extension strength.
ACTIVLIMOther
Activity limitations, as measured by ACTIVLIM, is defined as the difficulties a patient may have in executing daily activities, whatever the strategies involved.
PREMOther
Also called Patient Reported Experience Measures
This questionnaire is made up of simple questions relating to the assessments and assessment tools that were used during the study.
SF-MPQOther
Also called Modified Short-form McGill Pain Questionnaire
The main component of the SF-MPQ consists of 15 descriptors (11 sensories; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
FSSOther
Also called Fatigue Severity Scale
The Fatigue Severity Scale is used to assess the severity of fatigue and its impact on daily living. The patient responds on a Likert-type scale ranging from 1 to 7.
IPAQOther
Also called International Physical Activity Questionnaire
This questionnaire assesses overall physical activity and the level of sedentary lifestyle during the last seven days.
Rang of motionOther
Also called EasyAngle
The EasyAngle® is a digital goniometer improving long established goniometric functionality with rotation, inclination, and scoliosis measurement capabilities.
GoniometryDevice
Also called Links Sensor System goniometers
The Links sensor system is a measuring device and consists of the Links Pods and the Links Hub. The Links pods contain an accelerometer, gyroscope and magnetometer to measure position relative to a global reference frame.
Video captured monitoringOther
Once every four weeks, while wearing the Yumen electronic goniometers (Links Sensor System), the patients will be asked to record on video three tasks related to:
- Upper limbs: hands to head
- Lower limbs: Sit to stand with or without the help of a person
- Self-defined important task: A task of the patient's choice, from a list of tasks, representative of his/her motor difficulties or hindrance to autonomy.
Activity monitoringDevice
Also called Activity assessment and physiological parameters
Wearable devices (connected watch) will collect health-related data on a 24/7 basis remotely as patients go through their daily routines at home and work.
| Study group | Role | What they receive |
|---|---|---|
| Principal | Other | Not described Receives: Other: 2MWT; Other: MFM32; Other: MyoGrip; Other: QOL-gNMD; Diagnostic Test: Spirometry; Device: Acceleromerty; Other: 10mWT; Other: PUL; Other: NSAA; Other: NSAD; Other: TANS; Other: MyoPinch; Other: MyoQuad; Other: ACTIVLIM; Other: PREM; Other: SF-MPQ; Other: FSS; Other: IPAQ; Other: Rang of motion; Device: Goniometry; Other: Video captured monitoring; Device: Activity monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global home evaluations' attendance
Proportion of home assessments carried out compared to the number of home assessments planned
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Compliance with filling out questionnaires at home
Analysis of the proportion of replies to the questionnaires at home
Measured: Through study completion, an average of 1 year
Compliance regarding using of the spirometer at home
Analysis of the proportion of valid spirometry data collected at home
Measured: Through study completion, an average of 1 year
Compliance regarding using of the LINKS sensors device at home
Analysis of the proportion of usable accelerometry data collected at home
Measured: Through study completion, an average of 1 year
Compliance regarding using of the activity sensor at home
Analysis of the proportion of usable data collected at home using the smartwatch
Measured: Through study completion, an average of 1 year
Compliance regarding achievement of video tasks at home
Analysis of the usability of the video tasks performed at home
Measured: Through study completion, an average of 1 year
Correlation of home and hospital spirometer Forced vital capacity measurements
Comparison of Forced vital capacity data collected during home and hospital spirometer measurements
Measured: Through study completion, an average of 1 year
Correlation of home and hospital spirometer peak expiratory flow measurements
Comparison of Peak expiratory flow data collected during home and hospital spirometer measurements
Measured: Through study completion, an average of 1 year
Correlation of home and hospital spirometer forced expiratory volume in 1 second measurements
Comparison of forced expiratory volume in 1 second data collected during home and hospital spirometer measurements
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start29 Jun 2023
- Primary completion6 Jun 2025
- Study completion6 Jun 2025
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 Neuromuscular DiseasesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Myologie, France
- Sponsor type
- University, hospital or other
- Collaborators
- Aparito Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798325
- Sponsor's protocol ID
- DT4RD
- Acronym
- DT4RD
- Status last verified
- Jun 2026
- First submitted
- 8 Mar 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hogrel JY, Santmarty P, Decostre V, Marques T, Gasnier E, Masingue M, Querin G, Paalman M, Kok S, Horstik J, Sangadji MA, Klap P, Ferrer-Mallol E, Le Barbier C, Smith Van Carroll L, Hoyle K, Mayhew AG, Muni-Lofra R, Davies EH, Straub V. Feasibility, validation and application of digital tools for remote monitoring in neuromuscular diseases: the DT4RD protocol. BMJ Open. 2026 Aug 27;16(8):e121014. doi: 10.1136/bmjopen-2026-121014.
PubMed 42660557
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Validation and Application of Digital Tools for the Follow-up of Neuromuscular Patient
- ClinicalTrials.gov ID
- NCT05798325
- Acronym / sponsor ID
- DT4RD / DT4RD
- Conditions
- Neuromuscular Diseases
- Keywords
- Neuromuscular Diseases, Dystrophy, Monitoring, Accelerometer, Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut de Myologie, FranceUniversity, hospital or other
- Collaborators
- Aparito Ltd.
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 4 Apr 2023 (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 low prevalence of rare diseases hinders the design of clinical studies with sufficient statistical power to demonstrate the efficacy of new drugs. This can only be achieved by setting up international multicentre studies, which is challenging due to a lack of objective, universal outcome measures that generate high-quality, reproducible data. One of the hurdles in attaining universal outcome measures for clinical trials is the difficulty to capture and distinguish ambulatory from non-ambulatory, autonomous and assistive or involuntary movements. This makes a trial assessing the ambulatory phase very challenging at this moment. Excluding many participants from trials and many patients from access to medication.
Integration and validation of the technology in trials, research and patients' lives is essential in overcoming this hurdle. For example, in dystrophinopathies separate outcome measures exist for ambulant and non-ambulant participants, but the relation between these outcome measures or a transitional outcome measure/end point is largely missing.
Following an exhaustive literature review, several tools have been selected to remotely follow various symptoms of neuromuscular patients including weakness, pain, fatigue, cognitive defects, motor impairments (including loss of dexterity, ataxia...), metabolic, respiratory and cardiac troubles, contractures, tremor, falls, hypo or hypersomnia... The toolbox includes common measures for all patients but may include additional measures specific to the patient's symptoms (hence in turn to the patients' disease).
The measurements are designed to not be invasive, intrusive or burdensome for the patient.
DT4RD is going to leverage state-of-the art technology, clinical rating scales and psychometric/data analysis to deliver fit for purpose remote clinical assessments of mobility to ensure maximum patient benefit, specifically:
- Compare face to face clinical data collected in hospital with Patient Generated Data recorded remotely
- Examine how sensors can enhance measurement potentially at home and during clinical visits
- Promote a clear focus on user centered design and the integration of technology
- Use reliability and validity analyses to equate any common measures (those with the same or a similar construct)
- Demonstrate a proof-of-concept model into which different measures can be interchangeable
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Principal | Other | Other: 2MWT, Other: MFM32, Other: MyoGrip, Other: QOL-gNMD, Diagnostic Test: Spirometry, Device: Acceleromerty, Other: 10mWT, Other: PUL, Other: NSAA, Other: NSAD, Other: TANS, Other: MyoPinch, Other: MyoQuad, Other: ACTIVLIM, Other: PREM, Other: SF-MPQ, Other: FSS, Other: IPAQ, Other: Rang of motion, Device: Goniometry, Other: Video captured monitoring, Device: Activity monitoring |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Aged between 12 and 60 years
- Patients with a genetically confirmed/molecular-proven neuromuscular or neurometabolic disease*
- Patients experiencing walking difficulties in the home and at high risk of limiting participation and walking outside of the home.
- Written informed consent
- Able to comply with all protocol requirements, including video recording
Key exclusion criteria (6 listed)
- Patients with undefined diagnosis or any diagnosis other than neuromuscular or neurometabolic disease
- Patient walking 10m in less than 10s
- Guardianship/trusteeship
- Pregnant or nursing women
- Patients having relevant concomitant pathologies that, in the appreciation of the investigator could interfere with protocol compliance
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 |
|---|---|---|
| 2MWTAlso: Two minutes walk testsTwo minutes walk tests. | Other | Principal |
| MFM32Also: Muscle Motor Function 32Motor Function Measurement (MFM) is a quantitative scale created to measure global motor functional abilities in a person with neuromuscular disease. | Other | Principal |
| MyoGripThe MyoGrip is a dynamometer for measuring grip strength. | Other | Principal |
| QOL-gNMDThe "Quality of Life in genetic Neuromuscular Disease" questionnaire (QoL-gNMD) is a patient reported outcome measure (PROM) tool specifically designed for patients with a lowly progressive neuromuscular disease with genetically predominant muscular damage | Other | Principal |
| SpirometryAlso: Spirobank SmartForced vital capacity (FVC), peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) will be measured in the hospital with the local hospital device (e.g. Vitalograph) under the supervision of the clinical evaluator, and at home with a portable device. | Diagnostic test | Principal |
| AcceleromertyAlso: Links sensor systemThe Links sensor system is a measuring device and consists of the Links Pods and the Links Hub. The Links pods contain an accelerometer, gyroscope and magnetometer to measure position relative to a global reference frame. | Device | Principal |
| 10mWT10 meters walking Test. | Other | Principal |
| PULAlso: Performance of Upper LimbThe Performance of the Upper Limb (PUL) is a functional scale specifically designed for assessing upper limb function in Duchenne muscular dystrophy. | Other | Principal |
| NSAAAlso: North Star Ambulatory AssessmentThe North Star Ambulatory Assessment (NSAA) is a 17-item rating scale that is used to measure functional motor abilities in ambulant children with Duchenne Muscular Dystrophy. | Other | Principal |
| NSADAlso: North Star Assessment for limb-girdle type muscular dystrophiesThe NSAD was developed to measure motor performance in ambulant and non-ambulant subjects as part of the clinical outcome study of dysferlinopathy. | Other | Principal |
| TANSAlso: Transition Assessment North StarThis scale is derived from the North Star Ambulatory Assessment and several items from the Egan Klassifikation Scale (EK2). | Other | Principal |
| MyoPinchThe MyoPinch is a high-precision dynamometer that allows the evaluation of key pinch strength. | Other | Principal |
| MyoQuadThe MyoQuad is a high-precision dynamometer that allows the evaluation of knee extension strength. | Other | Principal |
| ACTIVLIMActivity limitations, as measured by ACTIVLIM, is defined as the difficulties a patient may have in executing daily activities, whatever the strategies involved. | Other | Principal |
| PREMAlso: Patient Reported Experience MeasuresThis questionnaire is made up of simple questions relating to the assessments and assessment tools that were used during the study. | Other | Principal |
| SF-MPQAlso: Modified Short-form McGill Pain QuestionnaireThe main component of the SF-MPQ consists of 15 descriptors (11 sensories; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. | Other | Principal |
| FSSAlso: Fatigue Severity ScaleThe Fatigue Severity Scale is used to assess the severity of fatigue and its impact on daily living. The patient responds on a Likert-type scale ranging from 1 to 7. | Other | Principal |
| IPAQAlso: International Physical Activity QuestionnaireThis questionnaire assesses overall physical activity and the level of sedentary lifestyle during the last seven days. | Other | Principal |
| Rang of motionAlso: EasyAngleThe EasyAngle® is a digital goniometer improving long established goniometric functionality with rotation, inclination, and scoliosis measurement capabilities. | Other | Principal |
| GoniometryAlso: Links Sensor System goniometersThe Links sensor system is a measuring device and consists of the Links Pods and the Links Hub. The Links pods contain an accelerometer, gyroscope and magnetometer to measure position relative to a global reference frame. | Device | Principal |
| Video captured monitoringOnce every four weeks, while wearing the Yumen electronic goniometers (Links Sensor System), the patients will be asked to record on video three tasks related to: 1. Upper limbs: hands to head 2. Lower limbs: Sit to stand with or without the help of a person 3. Self-defined important task: A task of the patient's choice, from a list of tasks, representative of his/her motor difficulties or hindrance to autonomy. | Other | Principal |
| Activity monitoringAlso: Activity assessment and physiological parametersWearable devices (connected watch) will collect health-related data on a 24/7 basis remotely as patients go through their daily routines at home and work. | Device | Principal |
Primary outcome
Global home evaluations' attendance
Time frame: Through study completion, an average of 1 year
Proportion of home assessments carried out compared to the number of home assessments planned
8 secondary outcomes
Compliance with filling out questionnaires at home
Time frame: Through study completion, an average of 1 year
Compliance regarding using of the spirometer at home
Time frame: Through study completion, an average of 1 year
Compliance regarding using of the LINKS sensors device at home
Time frame: Through study completion, an average of 1 year
Compliance regarding using of the activity sensor at home
Time frame: Through study completion, an average of 1 year
Compliance regarding achievement of video tasks at home
Time frame: Through study completion, an average of 1 year
Correlation of home and hospital spirometer Forced vital capacity measurements
Time frame: Through study completion, an average of 1 year
Correlation of home and hospital spirometer peak expiratory flow measurements
Time frame: Through study completion, an average of 1 year
Correlation of home and hospital spirometer forced expiratory volume in 1 second measurements
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 42660557Hogrel JY, Santmarty P, Decostre V, Marques T, Gasnier E, Masingue M, Querin G, Paalman M, Kok S, Horstik J, Sangadji MA, Klap P, Ferrer-Mallol E, Le Barbier C, Smith Van Carroll L, Hoyle K, Mayhew AG, Muni-Lofra R, Davies EH, Straub V. Feasibility, validation and application of digital tools for remote monitoring in neuromuscular diseases: the DT4RD protocol. BMJ Open. 2026 Aug 27;16(8):e121014. doi: 10.1136/bmjopen-2026-121014.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2MWT, MFM32 and MyoGrip in people with Neuromuscular Diseases, run by Institut de Myologie, France at 2 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 6 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: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global home evaluations' attendance (time frame: Through study completion, an average of 1 year). 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 NCT05798325, 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 29 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.