Spinal AmyotrophySMAdultNCT07894185
SMAdult - Monitoring of Movement on Spinal Muscular Atrophy
A study testing wearable sensors in people with Spinal Amyotrophy, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
Spinal muscular atrophy (SMA) is a rare neuromuscular disease causing progressive muscle weakness related to degeneration of motor neurons. With the arrival of new treatments, the natural history of SMA is changing significantly, and treatments in adults have been associated with disease stabilization and a reduction… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Spinal Amyotrophy
- What is being tested?
- wearable sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jul 2026to Mar 2029
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with genetically confirmed spinal muscular atrophy and available SMN2 copy number or if unavailable, they will be offered the option to send a DBS (dried blood spot) for SMN2 copy evaluation.
- On stable Disease modifying treatment for at least one year.
- The participant must be willing and able to provide written informed consent for study participation.
- Aged 15 years or older.
Who cannot join
- Any acute or chronic condition that, in the investigator's opinion, significantly interferes with assessments and/or motor development.
- Participation in a therapeutic trial with unapproved treatment.
- absence of internet connection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Centre de référence des maladies neuromusculaires, Centre Hospitalier Régional de la Citadelle
Liège, 4000
Marie Machiels, +32 (0)4 321 52 99, marie.machiels@doct.uliege.be
About this study
Official title: Decentralised Monitoring of Motor Function in Adolescents Aged 15 and Older and Adults With Spinal Muscular Atrophy (2026-184)
Spinal muscular atrophy (SMA) is a rare neuromuscular disease causing progressive muscle weakness related to degeneration of motor neurons. With the arrival of new treatments, the natural history of SMA is changing significantly, and treatments in adults have been associated with disease stabilization and a reduction in fatigue. However, functional assessment of adult patients remains difficult: their motor performance is highly fluctuating and hospital-based tests incompletely capture these daily variations.
Wearable devices, such as Syde®, now allow continuous monitoring in real life. The Syde® device, already used in Duchenne muscular dystrophy, provides digital measures describing gait and overall motor activity. However, no fully validated digital measure currently exists in adults with SMA.
Read more
The SMAdult study aims to address this gap through a precise, longitudinal, and fully decentralized follow-up of adults with SMA.
Objectives
- Primary objectives: Evaluation of the usability, reliability, and optimal use of a wearable device (Syde®) to monitor motor evolution in adults with SMA.
- Secondary objectives: To study the clinical validity of digital biomarkers by correlating them with functional scales (HFMSE, RULM). To determine the ability of digital measures to discriminate patients according to SMN2 copy number, phenotype, or treatments received. To follow the longitudinal evolution of Syde® measures in order to identify decline, stabilization, or improvement. To analyze subjective perception of progression through validated questionnaires and interviews.
Methodology Study type Academic, monocentric, prospective, fully decentralized study. Total duration: 36 months (24 months of inclusion, and between 12 and 30 months of follow-up).
Target population 60 adults aged over 15 years with genetically confirmed SMA. With a minimum of 20 ambulatory patients and 20 non-ambulatory patients.
On stable treatment for more than 1 year.
Procedure:
- Remote inclusion, with electronic consent via electronic software such as DocuSign.
- Follow-up every 6 months by questionnaire and videoconference.
- Use of a connected home device: Syde® (gait sensor).
- No hospital visits required.
- Collection of motor data, routine clinical information, validated questionnaires on swallowing, CGI questionnaire improvement and comparison.
Benefits and risks
- Direct benefits: limited but potential (enhanced monitoring).
- Collective benefits: improvement of monitoring tools and outcome measures in adult SMA patients.
- Risks: very low; use of non-invasive sensors with no known side effects.
Ethical aspects
- Compliance with GCP and GDPR.
- Oral and electronic informed consent.
- Pseudonymized data, analyzed by approved partners (SYSNAV).
- No compensation planned; no travel required.
- Insurance provided by the sponsor
Read the detailed description
This clinical study aims to evaluate motor function in adolescents aged 15 years and older and adults with spinal muscular atrophy (SMA). The objective is to identify and quantify motor impairments associated with different forms of the disease. No direct clinical benefit is expected for participants.
SMA is a rare neuromuscular disorder characterized by progressive muscle weakness due to degeneration of motor neurons. With the advent of disease-modifying therapies, the natural history of SMA is changing significantly. In adults, treatment has been associated with disease stabilization and reduced fatigue. However, functional assessment in adult patients remains challenging, as motor performance is highly variable and standard hospital-based evaluations do not fully capture daily fluctuations.
Wearable devices, such as the Syde® system, now enable continuous real-world monitoring. The Syde® device, already used in Duchenne muscular dystrophy, provides digital measures of gait and overall motor activity. However, no fully validated digital outcome measures are currently available in adults with SMA.
The SMAdult study aims to address this gap through a precise, longitudinal, and fully decentralized follow-up of individuals with SMA.
This is an academic, monocentric, prospective, fully decentralized study with an overall duration of 36 months, including a 24-month inclusion period and 12 to 30 months of follow-up.
The study will include approximately 60 participants aged 15 years and older with genetically confirmed SMA, including a minimum of 20 ambulatory and 20 non-ambulatory participants. All participants must have been on a stable treatment regimen for more than one year and must not be enrolled in a therapeutic clinical trial.
Remote inclusion is performed using electronic informed consent. Follow-up assessments are conducted every six months via secure videoconference and electronic questionnaires. Participants use a connected wearable device (Syde®) at home to continuously collect motor activity data during defined recording periods. No hospital visits are required.
Data collected include motor activity parameters, routine clinical information, validated questionnaires (including swallowing and quality of life assessments), and patient-reported outcomes regarding disease perception and progression. Clinical data are complemented by standardized reports and genetic confirmation collected through a secure electronic platform.
As part of regulatory requirements, information on ethnic background is collected to allow stratified analyses across population groups. These data are pseudonymized, treated confidentially, and used exclusively for research purposes. Participation in this component is optional and does not affect study participation or clinical care.
The Syde® system consists of two wearable sensors, a docking station for data transfer and charging, and dedicated analysis software. The device records three-dimensional movement in daily life in a non-invasive manner. Recording periods include an initial four-week phase for reliability assessment, followed by repeated four-week monitoring periods every six months.
The study is conducted in accordance with Good Clinical Practice (GCP), applicable ethical regulations, and GDPR requirements. Data are pseudonymized and securely stored. The study is sponsored by CHU de Liège, with appropriate insurance coverage.
- Conditions
- Spinal Amyotrophy
- Being tested
- wearable sensors
- Keywords
- spinal muscular atrophy (SMA), biomarker, wearable devices
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable sensorsDevice
Syde® wearable devices will be shipped directly to participants' homes. Each participant will wear two sensors, using the "ankle-wrist" configuration for both ambulant and non-ambulant individuals.
Initial recording period: continuous wear for 4 weeks Longitudinal follow-up: continuous wear for 4 weeks every 6 months Participants will receive detailed instructions and remote technical support if needed.
| Study group | Role | What they receive |
|---|---|---|
| SMA Ambulant | Other | Not described Receives: Device: wearable sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device usage (recording time)
Total recording time per recording period (hours)
Measured: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Patient compliance (Min)
Percentage of participants achieving minimal threshold (expected 50h) of recording time per period
Measured: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Patient compliance (Max)
Percentage of participants achieving optimal threshold (expected 180h) of recording time per period
Measured: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24, month 30, Month 36
Reliability
Intraclass Correlation Coefficient (ICC) for two distinct consecutive half-periods
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Secondary outcomes (6)
Clinical validity of digital outcome vs functional scale scores.
Correlation between digital outcomes and functional scale scores obtained from the functional assessments available for each patient during follow-up, including the Hammersmith Functional Motor Scale - Expanded (HFMSE; 0-66, higher scores indicate better motor function), Revised Upper Limb Module (RULM; 0-37, higher scores indicate better upper limb function), 4-Stair Climb (4SC; time in seconds, lower times indicate better functional performance), Brooke Upper Extremity Functional Rating Scale (1-6, lower scores indicate better upper limb function), Hammersmith Functional Motor Scale - Short Module (Hammersmith Short Module; [score range], higher scores indicate better motor function), and Motor Function Measure - 32 items (MFM-32; 0-96, higher scores indicate better motor function). Only functional scales available for a given patient will be included in the correlation analyses.
Measured: Day 1, 1 year, 2 years
Syde® digital motor outcomes according to SMN2 copy number and patient/control group.
Comparison of digital motor outcomes assessed using the Syde® system between SMA participants with different SMN2 copy numbers and ACTI-CONTROL participants.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Changes in digital motor outcomes assessed using the Syde® system from baseline to each follow-up assessment.
Change from baseline in digital motor outcome measurements assessed using the Syde® system at Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36. Multiple parameters generated by the Syde® system will be analysed and reported separately, where applicable.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Longitudinal analysis of digital motor outcomes assessed using the Syde® system.
Analysis of changes in digital motor outcome measurements assessed using the Syde® system across follow-up assessments to characterize disease progression, stabilization, or improvement over time.
Measured: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Patient perception of disease progression.
Assessment of patient-perceived disease progression, including changes in mobility, functional capacity, and disease stability, using qualitative interviews and the Patient Global Impression of Change (PGI-C). Results will be compared with digital motor outcomes assessed using the Syde® system to evaluate concordance between patient perceptions and digital biomarkers.
Measured: 1 day, 1 year, 2 years
Qualitative data on swallowing and its association with different genotypes.
DHI or other validated bulbar tests (cf appendix), and correlation with other parameters (genotype and treatment)
Measured: 1 day, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start17 Jul 2026
- Primary completion28 Mar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AmyotrophyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Collaborators
- SYSNAV, Centre Hospitalier Régional de la Citadelle
- Responsible party
- Principal investigator, Tamara DANGOULOFF, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894185
- Sponsor's protocol ID
- SMAdult
- Acronym
- SMAdult
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decentralised Monitoring of Motor Function in Adolescents Aged 15 and Older and Adults With Spinal Muscular Atrophy (2026-184)
- ClinicalTrials.gov ID
- NCT07894185
- Acronym / sponsor ID
- SMAdult / SMAdult
- Conditions
- Spinal Amyotrophy
- Keywords
- spinal muscular atrophy (SMA), biomarker, wearable devices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Collaborators
- SYSNAV, Centre Hospitalier Régional de la Citadelle
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 28 Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 26 Oct 2026 (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.
Spinal muscular atrophy (SMA) is a rare neuromuscular disease causing progressive muscle weakness related to degeneration of motor neurons. With the arrival of new treatments, the natural history of SMA is changing significantly, and treatments in adults have been associated with disease stabilization and a reduction in fatigue. However, functional assessment of adult patients remains difficult: their motor performance is highly fluctuating and hospital-based tests incompletely capture these daily variations.
Wearable devices, such as Syde®, now allow continuous monitoring in real life. The Syde® device, already used in Duchenne muscular dystrophy, provides digital measures describing gait and overall motor activity. However, no fully validated digital measure currently exists in adults with SMA.
The SMAdult study aims to address this gap through a precise, longitudinal, and fully decentralized follow-up of adults with SMA.
Objectives
- Primary objectives: Evaluation of the usability, reliability, and optimal use of a wearable device (Syde®) to monitor motor evolution in adults with SMA.
- Secondary objectives: To study the clinical validity of digital biomarkers by correlating them with functional scales (HFMSE, RULM). To determine the ability of digital measures to discriminate patients according to SMN2 copy number, phenotype, or treatments received. To follow the longitudinal evolution of Syde® measures in order to identify decline, stabilization, or improvement. To analyze subjective perception of progression through validated questionnaires and interviews.
Methodology Study type Academic, monocentric, prospective, fully decentralized study. Total duration: 36 months (24 months of inclusion, and between 12 and 30 months of follow-up).
Target population 60 adults aged over 15 years with genetically confirmed SMA. With a minimum of 20 ambulatory patients and 20 non-ambulatory patients.
On stable treatment for more than 1 year.
Procedure:
- Remote inclusion, with electronic consent via electronic software such as DocuSign.
- Follow-up every 6 months by questionnaire and videoconference.
- Use of a connected home device: Syde® (gait sensor).
- No hospital visits required.
- Collection of motor data, routine clinical information, validated questionnaires on swallowing, CGI questionnaire improvement and comparison.
Benefits and risks
- Direct benefits: limited but potential (enhanced monitoring).
- Collective benefits: improvement of monitoring tools and outcome measures in adult SMA patients.
- Risks: very low; use of non-invasive sensors with no known side effects.
Ethical aspects
- Compliance with GCP and GDPR.
- Oral and electronic informed consent.
- Pseudonymized data, analyzed by approved partners (SYSNAV).
- No compensation planned; no travel required.
- Insurance provided by the sponsor
Detailed description
This clinical study aims to evaluate motor function in adolescents aged 15 years and older and adults with spinal muscular atrophy (SMA). The objective is to identify and quantify motor impairments associated with different forms of the disease. No direct clinical benefit is expected for participants.
SMA is a rare neuromuscular disorder characterized by progressive muscle weakness due to degeneration of motor neurons. With the advent of disease-modifying therapies, the natural history of SMA is changing significantly. In adults, treatment has been associated with disease stabilization and reduced fatigue. However, functional assessment in adult patients remains challenging, as motor performance is highly variable and standard hospital-based evaluations do not fully capture daily fluctuations.
Wearable devices, such as the Syde® system, now enable continuous real-world monitoring. The Syde® device, already used in Duchenne muscular dystrophy, provides digital measures of gait and overall motor activity. However, no fully validated digital outcome measures are currently available in adults with SMA.
The SMAdult study aims to address this gap through a precise, longitudinal, and fully decentralized follow-up of individuals with SMA.
This is an academic, monocentric, prospective, fully decentralized study with an overall duration of 36 months, including a 24-month inclusion period and 12 to 30 months of follow-up.
The study will include approximately 60 participants aged 15 years and older with genetically confirmed SMA, including a minimum of 20 ambulatory and 20 non-ambulatory participants. All participants must have been on a stable treatment regimen for more than one year and must not be enrolled in a therapeutic clinical trial.
Remote inclusion is performed using electronic informed consent. Follow-up assessments are conducted every six months via secure videoconference and electronic questionnaires. Participants use a connected wearable device (Syde®) at home to continuously collect motor activity data during defined recording periods. No hospital visits are required.
Data collected include motor activity parameters, routine clinical information, validated questionnaires (including swallowing and quality of life assessments), and patient-reported outcomes regarding disease perception and progression. Clinical data are complemented by standardized reports and genetic confirmation collected through a secure electronic platform.
As part of regulatory requirements, information on ethnic background is collected to allow stratified analyses across population groups. These data are pseudonymized, treated confidentially, and used exclusively for research purposes. Participation in this component is optional and does not affect study participation or clinical care.
The Syde® system consists of two wearable sensors, a docking station for data transfer and charging, and dedicated analysis software. The device records three-dimensional movement in daily life in a non-invasive manner. Recording periods include an initial four-week phase for reliability assessment, followed by repeated four-week monitoring periods every six months.
The study is conducted in accordance with Good Clinical Practice (GCP), applicable ethical regulations, and GDPR requirements. Data are pseudonymized and securely stored. The study is sponsored by CHU de Liège, with appropriate insurance coverage.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMA Ambulant | Other | Device: wearable sensors |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with genetically confirmed spinal muscular atrophy and available SMN2 copy number or if unavailable, they will be offered the option to send a DBS (dried blood spot) for SMN2 copy evaluation.
- On stable Disease modifying treatment for at least one year.
- The participant must be willing and able to provide written informed consent for study participation.
- Aged 15 years or older.
Key exclusion criteria (3 listed)
- Any acute or chronic condition that, in the investigator's opinion, significantly interferes with assessments and/or motor development.
- Participation in a therapeutic trial with unapproved treatment.
- absence of internet connection.
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 |
|---|---|---|
| wearable sensorsSyde® wearable devices will be shipped directly to participants' homes. Each participant will wear two sensors, using the "ankle-wrist" configuration for both ambulant and non-ambulant individuals. Initial recording period: continuous wear for 4 weeks Longitudinal follow-up: continuous wear for 4 weeks every 6 months Participants will receive detailed instructions and remote technical support if needed. | Device | SMA Ambulant |
Primary outcome
Device usage (recording time)
Time frame: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Total recording time per recording period (hours)
Patient compliance (Min)
Time frame: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Percentage of participants achieving minimal threshold (expected 50h) of recording time per period
Patient compliance (Max)
Time frame: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24, month 30, Month 36
Percentage of participants achieving optimal threshold (expected 180h) of recording time per period
Reliability
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Intraclass Correlation Coefficient (ICC) for two distinct consecutive half-periods
6 secondary outcomes
Clinical validity of digital outcome vs functional scale scores.
Time frame: Day 1, 1 year, 2 years
Syde® digital motor outcomes according to SMN2 copy number and patient/control group.
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Changes in digital motor outcomes assessed using the Syde® system from baseline to each follow-up assessment.
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Longitudinal analysis of digital motor outcomes assessed using the Syde® system.
Time frame: Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
Patient perception of disease progression.
Time frame: 1 day, 1 year, 2 years
Qualitative data on swallowing and its association with different genotypes.
Time frame: 1 day, 1 year, 2 years
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 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Spinal Amyotrophy
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingObservational study
A Study of Risdiplam in Participants With Type I and Type II Spinal Muscle Atrophy (SMA)
Spinal Muscle Atrophy
RecruitingPhase 3
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Metastatic Castration Resistant Prostate Cancer
Recruiting
Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers
Spinal Muscular Atrophy (SMA), Charcot-Marie-Tooth
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 wearable sensors in people with Spinal Amyotrophy, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
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 3 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 26 Oct 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 Belgium. 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 Tamara Dangouloff, PhD (+33662438138, tamara.dangouloff@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device usage (recording time) (time frame: Recording periods at Baseline, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36). 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?
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 26 Oct 2026.