Spinal Muscular Atrophy (SMA)Active-NBS BENCT07286565
Active NBS Study: Decentralised Monitoring Motor Development in Children With Duchenne Muscular Dystrophy or Spinal Muscular Atrophy Identified by Newborn Screening
A study testing MAIJU, Syde and Questionnaires in people with Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMD), run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
The Active NBS Liege study is a monocentric, academic, fully remote, observational study designed to validate digital measures of motor development in children with spinal muscular atrophy (SMA) or Duchenne muscular dystrophy (DMD) identified through newborn screening, family testing, or incidental diagnosis. Read more about this study
- Who is it for?
- Ages 4 months and older
- Conditions the study is for
- Spinal Muscular Atrophy (SMA), Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- MAIJU, Syde and Questionnaires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2025to Aug 2028
- 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 4 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Genetically confirmed SMA and avalaible MSNA2 copy number:
- Identified by newborn screening,
- Identified by family screening, or incidental diagnosis in pre-symptomatic stage
- Treated (or follow-up possible for patients with 4 SMN2 copies)
- Genetically confirmed DMD:
- Identified by newborn screening,
Show all 9Show fewer
- Identified by family screening, or incidental diagnosis in pre-symptomatic stage
- Age < 4 years at inclusion
- Legal guardian able to provide informed consent
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.
- Lack 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.
Marie Machiels contact
Belgium1 site, 1 recruiting
- Recruiting
Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
Liège, 4000
Tamara Dangouloff, PhD, 0033662438138, tamara.dangouloff@uliege.be
About this study
Official title: Active-NBS Liege - Monitoring the Motor Development of Children With Duchenne Muscular Dystrophy or Spinal Muscular Atrophy Identified Through Newborn Screening
The Active NBS Liege study is a monocentric, academic, fully remote, observational study designed to validate digital measures of motor development in children with spinal muscular atrophy (SMA) or Duchenne muscular dystrophy (DMD) identified through newborn screening, family testing, or incidental diagnosis. The study will enroll 100 children and follow them longitudinally for up to 30 months. Participants are remotely recruited, and all procedures, including consent, questionnaires, and follow-up visits, are conducted by phone or video conferencing without any hospital visits. Children will use age-appropriate wearable devices at home: MAIJU®, a sensorized garment for non-ambulant infants, and Syde®, an ankle-worn sensor for ambulant children. Data collection includes digital motor endpoints, clinical information, and quality of life (PedsQL). Primary objectives are to validate digital biomarkers of motor development, while secondary objectives include early identification of motor deficits, modeling motor trajectories, and quantifying genotype-related differences. Exploratory analyses will assess gait parameters such as stride velocity 95th centile (SV95C) and compare motor outcomes across genetic profiles and treatment exposure. Risks are minimal, limited to the use of non-invasive sensors with no known side effects.
Read the detailed description
Duchenne muscular dystrophy (DMD) and spinal muscular atrophy (SMA) are severe, progressive, and life-limiting neuromuscular disorders that manifest during early childhood. Both conditions are characterized by motor function decline, leading to severe disability and premature mortality. The availability of disease-modifying therapies has dramatically changed the clinical landscape, but their effectiveness is strongly dependent on very early initiation, ideally before symptom onset.
Newborn screening (NBS) for SMA has now been implemented in several countries, enabling the identification of affected infants at birth. This shift creates a new challenge: the need to monitor presymptomatic or minimally symptomatic children over time with sensitive, reliable, and age-appropriate tools. Conventional motor function scales were designed for older children and are not sufficiently adapted for infants and toddlers. As a result, there is a critical gap in longitudinal assessment during the first years of life, a period when therapeutic interventions may have the greatest impact.
The Active NBS study was designed to address this unmet need. This is a monocentric, fully remote, academic, observational study that leverages wearable digital technologies to monitor motor development in very young children with SMA or DMD. The study is conducted entirely at a distance, with no requirement for hospital visits, thereby reducing the burden on families and improving accessibility.
Study Objectives:
The primary objective is to validate digital biomarkers of early motor development in children diagnosed with SMA or DMD. Secondary objectives include the early detection of motor deficits, quantification of developmental delays according to genetic subtype, and modeling of motor trajectories during the first years of life. Exploratory objectives focus on gait analysis, including stride velocity 95th centile (SV95C), and comparisons of motor outcomes across genetic backgrounds and treatment exposure.
Study Design and Procedures:
Up to 100 children will be enrolled, including infants identified by NBS, family testing, or incidental diagnosis. Enrollment and informed consent are performed remotely using secure electronic platforms. Participants are followed prospectively for up to 30 months, with assessments every 6 months through structured questionnaires and video consultations with the study team.
Two wearable devices will be employed, depending on the child's age and motor status:
- MAIJU® (Motor Assessment of Infants with a Jumpsuit): a sensorized garment designed for non-ambulant infants, capturing spontaneous movement and generating a composite biomarker (Babacloud Infant Motility Score, BIMS).
- Syde®: a wearable ankle sensor validated in ambulant children, enabling precise gait monitoring and calculation of SV95C, a regulatory-accepted endpoint in DMD.
Data collected include digital motor endpoints, routine clinical information, and quality of life metrics (PedsQL). Families are instructed on the correct use of devices and can install and remove them independently at home. No travel or in-person assessments are required, making this approach particularly suitable for rare disease populations.
Scientific Rationale:
Traditional motor scales, while validated in older children, lack sensitivity to detect subtle developmental changes in infancy and early childhood. Digital endpoints derived from continuous movement monitoring have the potential to provide richer, objective data on motor development. By validating these measures in a presymptomatic or early symptomatic population, this study aims to establish novel tools for both clinical practice and future interventional trials. Importantly, the study also addresses the practical and ethical challenges of long-term follow-up in very young children by implementing a fully remote design.
Expected Impact:
The Active NBS study is expected to generate the first large-scale, longitudinal dataset on motor development in presymptomatic and early symptomatic children with SMA and DMD. The validation of digital endpoints such as SV95C and BIMS will contribute to the development of sensitive outcome measures for clinical trials and may support regulatory acceptance in the future. Beyond its immediate scientific goals, the study demonstrates the feasibility and acceptability of decentralized follow-up in rare pediatric populations, setting the stage for broader applications of digital health technologies in neuromuscular disorders.
- Being tested
- MAIJU, Syde, Questionnaires, PedsQL Questionnaire
- Keywords
- Remotely monitor, Syde, Accelerometry, Daily living
- Medical subject headings
- Muscular Atrophy, Spinal, Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAIJUDevice
A jumpsuit equipped with motion sensors for detailed assessment of motor development and postural changes. Developed by the University of Helsinki, it enables remote evaluation of infants and their motor behavior. The device has been extensively validated in healthy infants and those with cerebral palsy
SydeDevice
The Syde® is a Class I medical device, CE-marked (compliant with European Regulation 2017/745) and manufactured by Sysnav (Vernon, France). The Syde® measures various gait parameters to assess motor abilities. It enabled the identification of SV95C in Duchenne muscular dystrophy (DMD), which became the first qualified primary endpoint in DMD, and the first digital outcome qualified by a regulatory agency. Data have been collected in about thirty DMD children under 4 years old and in an age-matched control population. These data demonstrated feasibility, reliability, and sensitivity to change in children from controls as soon as walking is acquired.
QuestionnairesOther
Parents will complete a specific questionnaire covering their child's medical history;
PedsQL QuestionnaireOther
Quality-of-life questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patient with spinal muscular atrophy | Experimental | Patients will wear a device (Maiju and/or Syde) and complete questionnaires. Receives: Device: MAIJU; Device: Syde; Other: Questionnaires; Other: PedsQL Questionnaire |
| Patient with Duchenne muscular disease | Experimental | Patients will wear a device (Maiju and/or Syde) and complete questionnaires. Receives: Device: MAIJU; Device: Syde; Other: Questionnaires; Other: PedsQL Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Mobility Monitoring Compliance
Measure of participant adherence to wearing the Syde® device: total recording time.
Measured: 4 weeks of recording periods every 3 months over 2 years
Digital Mobility Monitoring Compliance
Measure of participant adherence to wearing the Syde® device: number of valid recording days (≥4 hours)
Measured: 4 weeks of recording periods every 3 months over 2 years
Digital Mobility Monitoring Compliance
Measure of participant adherence to wearing the Syde® device: time to reach 50 and 180 hours of recording.
Measured: 4 weeks of recording periods every 3 months over 2 years
Digital Mobility Monitoring Compliance
Measure of participant adherence to wearing the MAIJU® device using total recording time.
Measured: 1 day of recording periods every month over 2 years
Walking Pattern Characteristics
Analysis of walking sequences: maximal walking sequence duration
Measured: 4 weeks of recording periods every 3 months over 2 years
Walking Pattern Characteristics
Analysis of walking sequences: maximal distance walked in a single sequence.
Measured: 4 weeks of recording periods every 3 months over 2 years
Walking Pattern Characteristics
Analysis of walking sequences: maximal 30-minute walking distance.
Measured: 4 weeks of recording periods every 3 months over 2 years
Reliability
Inter Class Correlation (ICC2K) when comparing the first and the second half of recordings that includes more than 100 hours AND more than 2000 steps
Measured: Baseline, 1 year, 2 years.
Group Differences in Digital Variables
Comparison of digital mobility metrics across subgroups defined by the number of SMN2 copies (SMA patients) and age's symptom appearance with
- Patients with SMA symptoms at treatment initiation
- Patients with 2 copies of SMN2 and no symptoms at treatment initiation
- Patients with 3 copies of SMN2 and no symptoms at treatment initiation
- Patients with 4 copies of SMN2
- Healthy controls
Measured: Age 2, 3 and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Dec 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular Atrophy (SMA)Studies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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, Leon Fredericq Foundation
- Responsible party
- Principal investigator, Tamara DANGOULOFF, Centre Hospitalier Universitaire de Liege
- Investigators
- Tamara Dangouloff, PhD, Principal investigator, University of LiegeLaurent Servais, MD, PhD, Study director, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286565
- Sponsor's protocol ID
- Active-NBS Liege
- Acronym
- Active-NBS BE
- Status last verified
- Dec 2025
- First submitted
- 5 Sep 2025
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active-NBS Liege - Monitoring the Motor Development of Children With Duchenne Muscular Dystrophy or Spinal Muscular Atrophy Identified Through Newborn Screening
- ClinicalTrials.gov ID
- NCT07286565
- Acronym / sponsor ID
- Active-NBS BE / Active-NBS Liege
- Keywords
- Remotely monitor, Syde, Accelerometry, Daily living
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Collaborators
- SYSNAV, Centre Hospitalier Régional de la Citadelle, Leon Fredericq Foundation
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 Dec 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 Active NBS Liege study is a monocentric, academic, fully remote, observational study designed to validate digital measures of motor development in children with spinal muscular atrophy (SMA) or Duchenne muscular dystrophy (DMD) identified through newborn screening, family testing, or incidental diagnosis. The study will enroll 100 children and follow them longitudinally for up to 30 months. Participants are remotely recruited, and all procedures, including consent, questionnaires, and follow-up visits, are conducted by phone or video conferencing without any hospital visits. Children will use age-appropriate wearable devices at home: MAIJU®, a sensorized garment for non-ambulant infants, and Syde®, an ankle-worn sensor for ambulant children. Data collection includes digital motor endpoints, clinical information, and quality of life (PedsQL). Primary objectives are to validate digital biomarkers of motor development, while secondary objectives include early identification of motor deficits, modeling motor trajectories, and quantifying genotype-related differences. Exploratory analyses will assess gait parameters such as stride velocity 95th centile (SV95C) and compare motor outcomes across genetic profiles and treatment exposure. Risks are minimal, limited to the use of non-invasive sensors with no known side effects.
Detailed description
Duchenne muscular dystrophy (DMD) and spinal muscular atrophy (SMA) are severe, progressive, and life-limiting neuromuscular disorders that manifest during early childhood. Both conditions are characterized by motor function decline, leading to severe disability and premature mortality. The availability of disease-modifying therapies has dramatically changed the clinical landscape, but their effectiveness is strongly dependent on very early initiation, ideally before symptom onset.
Newborn screening (NBS) for SMA has now been implemented in several countries, enabling the identification of affected infants at birth. This shift creates a new challenge: the need to monitor presymptomatic or minimally symptomatic children over time with sensitive, reliable, and age-appropriate tools. Conventional motor function scales were designed for older children and are not sufficiently adapted for infants and toddlers. As a result, there is a critical gap in longitudinal assessment during the first years of life, a period when therapeutic interventions may have the greatest impact.
The Active NBS study was designed to address this unmet need. This is a monocentric, fully remote, academic, observational study that leverages wearable digital technologies to monitor motor development in very young children with SMA or DMD. The study is conducted entirely at a distance, with no requirement for hospital visits, thereby reducing the burden on families and improving accessibility.
Study Objectives:
The primary objective is to validate digital biomarkers of early motor development in children diagnosed with SMA or DMD. Secondary objectives include the early detection of motor deficits, quantification of developmental delays according to genetic subtype, and modeling of motor trajectories during the first years of life. Exploratory objectives focus on gait analysis, including stride velocity 95th centile (SV95C), and comparisons of motor outcomes across genetic backgrounds and treatment exposure.
Study Design and Procedures:
Up to 100 children will be enrolled, including infants identified by NBS, family testing, or incidental diagnosis. Enrollment and informed consent are performed remotely using secure electronic platforms. Participants are followed prospectively for up to 30 months, with assessments every 6 months through structured questionnaires and video consultations with the study team.
Two wearable devices will be employed, depending on the child's age and motor status:
- MAIJU® (Motor Assessment of Infants with a Jumpsuit): a sensorized garment designed for non-ambulant infants, capturing spontaneous movement and generating a composite biomarker (Babacloud Infant Motility Score, BIMS).
- Syde®: a wearable ankle sensor validated in ambulant children, enabling precise gait monitoring and calculation of SV95C, a regulatory-accepted endpoint in DMD.
Data collected include digital motor endpoints, routine clinical information, and quality of life metrics (PedsQL). Families are instructed on the correct use of devices and can install and remove them independently at home. No travel or in-person assessments are required, making this approach particularly suitable for rare disease populations.
Scientific Rationale:
Traditional motor scales, while validated in older children, lack sensitivity to detect subtle developmental changes in infancy and early childhood. Digital endpoints derived from continuous movement monitoring have the potential to provide richer, objective data on motor development. By validating these measures in a presymptomatic or early symptomatic population, this study aims to establish novel tools for both clinical practice and future interventional trials. Importantly, the study also addresses the practical and ethical challenges of long-term follow-up in very young children by implementing a fully remote design.
Expected Impact:
The Active NBS study is expected to generate the first large-scale, longitudinal dataset on motor development in presymptomatic and early symptomatic children with SMA and DMD. The validation of digital endpoints such as SV95C and BIMS will contribute to the development of sensitive outcome measures for clinical trials and may support regulatory acceptance in the future. Beyond its immediate scientific goals, the study demonstrates the feasibility and acceptability of decentralized follow-up in rare pediatric populations, setting the stage for broader applications of digital health technologies in neuromuscular disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with spinal muscular atrophy | Experimental | Device: MAIJU, Device: Syde, Other: Questionnaires, Other: PedsQL QuestionnairePatients will wear a device (Maiju and/or Syde) and complete questionnaires. |
| Patient with Duchenne muscular disease | Experimental | Device: MAIJU, Device: Syde, Other: Questionnaires, Other: PedsQL QuestionnairePatients will wear a device (Maiju and/or Syde) and complete questionnaires. |
Who may qualify
- Ages
- 4 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Identified by newborn screening,
- Identified by family screening, or incidental diagnosis in pre-symptomatic stage
- Treated (or follow-up possible for patients with 4 SMN2 copies)
- Identified by newborn screening,
- Identified by family screening, or incidental diagnosis in pre-symptomatic stage
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.
- Lack 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 |
|---|---|---|
| MAIJUA jumpsuit equipped with motion sensors for detailed assessment of motor development and postural changes. Developed by the University of Helsinki, it enables remote evaluation of infants and their motor behavior. The device has been extensively validated in healthy infants and those with cerebral palsy | Device | Patient with Duchenne muscular disease, Patient with spinal muscular atrophy |
| SydeThe Syde® is a Class I medical device, CE-marked (compliant with European Regulation 2017/745) and manufactured by Sysnav (Vernon, France). The Syde® measures various gait parameters to assess motor abilities. It enabled the identification of SV95C in Duchenne muscular dystrophy (DMD), which became the first qualified primary endpoint in DMD, and the first digital outcome qualified by a regulatory agency. Data have been collected in about thirty DMD children under 4 years old and in an age-matched control population. These data demonstrated feasibility, reliability, and sensitivity to change in children from controls as soon as walking is acquired. | Device | Patient with Duchenne muscular disease, Patient with spinal muscular atrophy |
| QuestionnairesParents will complete a specific questionnaire covering their child's medical history; | Other | Patient with Duchenne muscular disease, Patient with spinal muscular atrophy |
| PedsQL QuestionnaireQuality-of-life questionnaire | Other | Patient with Duchenne muscular disease, Patient with spinal muscular atrophy |
Primary outcome
Digital Mobility Monitoring Compliance
Time frame: 4 weeks of recording periods every 3 months over 2 years
Measure of participant adherence to wearing the Syde® device: total recording time.
Digital Mobility Monitoring Compliance
Time frame: 4 weeks of recording periods every 3 months over 2 years
Measure of participant adherence to wearing the Syde® device: number of valid recording days (≥4 hours)
Digital Mobility Monitoring Compliance
Time frame: 4 weeks of recording periods every 3 months over 2 years
Measure of participant adherence to wearing the Syde® device: time to reach 50 and 180 hours of recording.
Digital Mobility Monitoring Compliance
Time frame: 1 day of recording periods every month over 2 years
Measure of participant adherence to wearing the MAIJU® device using total recording time.
Walking Pattern Characteristics
Time frame: 4 weeks of recording periods every 3 months over 2 years
Analysis of walking sequences: maximal walking sequence duration
Walking Pattern Characteristics
Time frame: 4 weeks of recording periods every 3 months over 2 years
Analysis of walking sequences: maximal distance walked in a single sequence.
Walking Pattern Characteristics
Time frame: 4 weeks of recording periods every 3 months over 2 years
Analysis of walking sequences: maximal 30-minute walking distance.
Reliability
Time frame: Baseline, 1 year, 2 years.
Inter Class Correlation (ICC2K) when comparing the first and the second half of recordings that includes more than 100 hours AND more than 2000 steps
Group Differences in Digital Variables
Time frame: Age 2, 3 and 4 years
Comparison of digital mobility metrics across subgroups defined by the number of SMN2 copies (SMA patients) and age's symptom appearance with 1. Patients with SMA symptoms at treatment initiation 2. Patients with 2 copies of SMN2 and no symptoms at treatment initiation 3. Patients with 3 copies of SMN2 and no symptoms at treatment initiation 4. Patients with 4 copies of SMN2 5. Healthy controls
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 16 Dec 2025.
- 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.
Marie Machiels contact
Tamara Dangouloff, PhD principal investigator
University of Liege
Laurent Servais, MD, PhD study director
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAIJU, Syde and Questionnaires in people with Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMD), 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 9 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 16 Dec 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 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?
Digital Mobility Monitoring Compliance (time frame: 4 weeks of recording periods every 3 months over 2 years). The study lists 9 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 16 Dec 2025.