Autism Spectrum DisorderNCT06805916
Promoting Communication in Minimally Verbal Autistic Children with Social Robot
A study testing NAO-Assisted Therapy and Standard therapeutic in people with Autism Spectrum Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
Minimally verbal (MV) children with Autism Spectrum Disorder (ASD) face significant challenges in communication and social interaction, which are fundamental to learning and development. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- NAO-Assisted Therapy and Standard therapeutic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2023to 30 Sep 2025
- 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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Autism Spectrum Disorder (ASD)
- Minimal verbal communication
- Age between 4 and 12 years.
Who cannot join
- Presence of severe intellectual disability.
- Diagnosis of neurological disorders other than ASD.
- Significant medical conditions that could interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Promoting Communicative Initiative in Minimally Verbal Autistic Children Through Interaction with the Humanoid Social Robot
Minimally verbal (MV) children with Autism Spectrum Disorder (ASD) face significant challenges in communication and social interaction, which are fundamental to learning and development. Current therapeutic approaches, such as speech therapy and augmentative communication systems, often have variable efficacy due to engagement and responsiveness challenges. This pilot study investigates using of the humanoid robot NAO as part of a rehabilitative program designed for MV children with ASD. NAO, with its predictable and engaging interaction style, is hypothesized to enhance communicative initiative, expressive communication, and social interaction in this population. The study employs a randomized controlled trial design, assigning participants to either an NAO-assisted intervention group or a control group receiving standard therapy. Outcomes will be assessed using standardized measures of communication, social interaction, and observational data. This research aims to explore the potential of social robots as an innovative tool to addressing the unique needs of MV children with ASD, contributing to the development of effective, accessible therapeutic options that improve their quality of life and that of their families.
Read the detailed description
Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by deficits in social communication and restricted, repetitive patterns of behavior, interests, or activities. Among individuals with ASD, approximately 25-30% are minimally verbal (MV), demonstrating limited verbal or non-verbal communication skills, which poses significant challenges for social interaction and learning. Early diagnosis and tailored therapeutic interventions are crucial for improving long-term outcomes in this population. However, traditional therapies often face limitations, including variability in efficacy and difficulty maintaining engagement among MV children. In recent years, the integration of advanced technologies into therapeutic programs has gained traction as an innovative approach to address communication challenges in ASD. Social robots, such as the humanoid robot NAO, offer unique opportunities to engage children with ASD through consistent and predictable interactions. NAO is equipped with capabilities including speech recognition, gestures, and responses to touch and movement, making it an effective tool for promoting communication and social behaviors. Preliminary studies suggest that social robots can enhance engagement and improve social skills in children with ASD, yet their potential remains underexplored in minimally verbal children. This single-blind, randomized, controlled study aims to evaluate the feasibility and effectiveness of a rehabilitative treatment program integrating the NAO robot for minimally verbal children with ASD. NAO-assisted therapy sessions are designed to promote communicative initiative, expressive language, and social interaction through interactive tasks tailored to each child's needs.
The study's outcomes will be measured using standardized communication assessments, including the Test of Verbalization (TVL), and observational data to evaluate engagement, responsiveness, and frequency of communicative behaviors. By leveraging advanced robotic technology, this study aims to explore new avenues for therapeutic interventions, ultimately contributing to the development of evidence-based strategies that improve the quality of life for minimally verbal children with ASD and their families.
- Conditions
- Autism Spectrum Disorder
- Being tested
- NAO-Assisted Therapy, Standard therapeutic
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAO-Assisted TherapyBehavioural
The intervention sessions included tasks designed to engage the child in verbal and social interactions, such as naming objects, responding to questions, and performing gestures. The NAO robot provided consistent and predictable feedback, while therapists supported and reinforced appropriate communicative behaviors.
Standard therapeuticBehavioural
Standard therapeutic approaches included exercises aimed at improving verbal communication and social engagement, such as naming objects, sentence construction, and comprehension tasks. Therapists adapted the intervention to the child's individual communication goals.
| Study group | Role | What they receive |
|---|---|---|
| NAO-Assisted Intervention (Experimental Group EG) | Experimental | The treatment group consists of 50 children diagnosed with Autism Spectrum Disorder (ASD) who are minimally verbal (MV). Participants were randomly assigned and underwent a structured rehabilitative program integrated with the use of the NAO humanoid robot. The intervention was tailored to individual needs and aimed at improving communicative initiative, verbalization, and social engagement. Each child received therapy over a period of 12 weeks, totaling 12 sessions, once per week, with each session lasting 45 minutes. Receives: Behavioral: NAO-Assisted Therapy |
| Standard Therapy (Control Group) | Active comparator | The control group consists of 50 children diagnosed with Autism Spectrum Disorder (ASD) who are minimally verbal (MV). Participants were randomly assigned and underwent standard therapeutic approaches, which included traditional speech therapy provided by trained therapists. The therapy followed established protocols and was adapted to meet the specific needs of minimally verbal children. Each child received therapy over a period of 12 weeks, totaling 12 sessions, once per week, with each session lasting 45 minutes. Receives: Behavioral: Standard therapeutic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language Development Level Test (TVL)
The Test of Verbalization and Language Development (TVL) is a standardized tool designed to assess various aspects of language development, including verbal production, comprehension, sentence construction, phonological accuracy, and morphosyntactic abilities. The weighted score ranges from 0 to 10, with higher scores indicating better language development.
Measured: T0(baseline)-T1(3months)
The Child Behavior Checklist (CBCL)
The Child Behavior Checklist (CBCL) is a caregiver-reported questionnaire used to identify emotional and behavioral problems in children. It measures multiple domains, including emotional reactivity, anxiety, attention problems, and social difficulties. The T-scores do not have a specific range, but values between 50 and 70 are considered within the normal range, while 70 to 100 indicates clinical significance. Higher scores indicate greater behavioral problems.
Measured: T0(baseline)-T1(3months)
Quality of Life in Autism Questionnaire (QoLA)
The Quality of Life in Autism Questionnaire (QoLA) is a standardized measure assessing the quality of life of parents of autistic children, focusing on emotional well-being, stress, and satisfaction with support services. The questionnaire consists of two parts:
- Part A: Scores range from 28 to 140, with higher scores indicating a better perceived quality of life.
- Part B: Scores range from 20 to 100, with higher scores indicating fewer problems for parents related to their child's ASD-related behaviors.
Measured: T0(baseline)-T1(3months)
Repetitive Behavior Scale (RBS)
The Repetitive Behavior Scale-Revised (RBS-R) is a caregiver-reported questionnaire assessing restricted and repetitive behaviors in autistic children, including stereotyped behaviors, self-injury, and compulsive behaviors. Each behavior is rated on a 4-point Likert scale. Higher scores indicate greater severity of repetitive behaviors.
Measured: T0(baseline)-T1(3months)
Strengths and Difficulties Questionnaire (SDQ)
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioral screening tool assessing emotional symptoms, conduct problems, hyperactivity, peer relationship problems, and prosocial behaviors in children aged 2-17 years.
For all scales except the prosocial behavior scale, higher scores indicate greater levels of distress. In the prosocial behavior scale, higher scores indicate stronger positive social behaviors.
Measured: T0(baseline)-T1(3months)
Conners' Parent Rating Scale (CPRS)
The Conners' Parent Rating Scale (CPRS) is a widely used research and clinical tool that gathers parental reports on childhood behavioral problems, particularly related to attention-deficit/hyperactivity disorder (ADHD) and associated behavioral concerns. T-scores above 70 indicate a higher likelihood of problematic behaviors and ADHD symptoms. Higher scores suggest greater severity of behavioral issues
Measured: T0(baseline)-T1(3months)
Mand Requests During Sessions
This observational measure tracks and records the number of spontaneous and prompted requests initiated by the child to express needs or desires during therapy sessions. Frequency count per session. Higher frequencies indicate greater communicative initiative
Measured: During Sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start2 Jan 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Cucinotta, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Margherita La Fauci, Principal investigator, IRCCS Centro Neurolesi Bonino PulejoMaria Tresoldi, Principal investigator, University Hospital "G. Martino"Marcella Di Cara, Principal investigator, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805916
- Sponsor's protocol ID
- NAO01
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hodges H, Fealko C, Soares N. Autism spectrum disorder: definition, epidemiology, causes, and clinical evaluation. Transl Pediatr. 2020 Feb;9(Suppl 1):S55-S65. doi: 10.21037/tp.2019.09.09.
PubMed 32206584Rose V, Trembath D, Keen D, Paynter J. The proportion of minimally verbal children with autism spectrum disorder in a community-based early intervention programme. J Intellect Disabil Res. 2016 May;60(5):464-77. doi: 10.1111/jir.12284.
PubMed 27120989Brignell A, Chenausky KV, Song H, Zhu J, Suo C, Morgan AT. Communication interventions for autism spectrum disorder in minimally verbal children. Cochrane Database Syst Rev. 2018 Nov 5;11(11):CD012324. doi: 10.1002/14651858.CD012324.pub2.
PubMed 30395694Korneder J, Louie WG, Pawluk CM, Abbas I, Brys M, Rooney F. Robot-mediated interventions for teaching children with ASD: A new intraverbal skill. Assist Technol. 2022 Nov 2;34(6):707-716. doi: 10.1080/10400435.2021.1930284. Epub 2021 May 28.
PubMed 33983864Salimi Z, Jenabi E, Bashirian S. Are social robots ready yet to be used in care and therapy of autism spectrum disorder: A systematic review of randomized controlled trials. Neurosci Biobehav Rev. 2021 Oct;129:1-16. doi: 10.1016/j.neubiorev.2021.04.009. Epub 2021 Apr 20.
PubMed 33862066
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Communicative Initiative in Minimally Verbal Autistic Children Through Interaction with the Humanoid Social Robot
- ClinicalTrials.gov ID
- NCT06805916
- Acronym / sponsor ID
- NAO01
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Feb 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.
Minimally verbal (MV) children with Autism Spectrum Disorder (ASD) face significant challenges in communication and social interaction, which are fundamental to learning and development. Current therapeutic approaches, such as speech therapy and augmentative communication systems, often have variable efficacy due to engagement and responsiveness challenges. This pilot study investigates using of the humanoid robot NAO as part of a rehabilitative program designed for MV children with ASD. NAO, with its predictable and engaging interaction style, is hypothesized to enhance communicative initiative, expressive communication, and social interaction in this population. The study employs a randomized controlled trial design, assigning participants to either an NAO-assisted intervention group or a control group receiving standard therapy. Outcomes will be assessed using standardized measures of communication, social interaction, and observational data. This research aims to explore the potential of social robots as an innovative tool to addressing the unique needs of MV children with ASD, contributing to the development of effective, accessible therapeutic options that improve their quality of life and that of their families.
Detailed description
Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by deficits in social communication and restricted, repetitive patterns of behavior, interests, or activities. Among individuals with ASD, approximately 25-30% are minimally verbal (MV), demonstrating limited verbal or non-verbal communication skills, which poses significant challenges for social interaction and learning. Early diagnosis and tailored therapeutic interventions are crucial for improving long-term outcomes in this population. However, traditional therapies often face limitations, including variability in efficacy and difficulty maintaining engagement among MV children. In recent years, the integration of advanced technologies into therapeutic programs has gained traction as an innovative approach to address communication challenges in ASD. Social robots, such as the humanoid robot NAO, offer unique opportunities to engage children with ASD through consistent and predictable interactions. NAO is equipped with capabilities including speech recognition, gestures, and responses to touch and movement, making it an effective tool for promoting communication and social behaviors. Preliminary studies suggest that social robots can enhance engagement and improve social skills in children with ASD, yet their potential remains underexplored in minimally verbal children. This single-blind, randomized, controlled study aims to evaluate the feasibility and effectiveness of a rehabilitative treatment program integrating the NAO robot for minimally verbal children with ASD. NAO-assisted therapy sessions are designed to promote communicative initiative, expressive language, and social interaction through interactive tasks tailored to each child's needs.
The study's outcomes will be measured using standardized communication assessments, including the Test of Verbalization (TVL), and observational data to evaluate engagement, responsiveness, and frequency of communicative behaviors. By leveraging advanced robotic technology, this study aims to explore new avenues for therapeutic interventions, ultimately contributing to the development of evidence-based strategies that improve the quality of life for minimally verbal children with ASD and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAO-Assisted Intervention (Experimental Group EG) | Experimental | Behavioral: NAO-Assisted TherapyThe treatment group consists of 50 children diagnosed with Autism Spectrum Disorder (ASD) who are minimally verbal (MV). Participants were randomly assigned and underwent a structured rehabilitative program integrated with the use of the NAO humanoid robot. The intervention was tailored to individual needs and aimed at improving communicative initiative, verbalization, and social engagement. Each child received therapy over a period of 12 weeks, totaling 12 sessions, once per week, with each session lasting 45 minutes. |
| Standard Therapy (Control Group) | Active comparator | Behavioral: Standard therapeuticThe control group consists of 50 children diagnosed with Autism Spectrum Disorder (ASD) who are minimally verbal (MV). Participants were randomly assigned and underwent standard therapeutic approaches, which included traditional speech therapy provided by trained therapists. The therapy followed established protocols and was adapted to meet the specific needs of minimally verbal children. Each child received therapy over a period of 12 weeks, totaling 12 sessions, once per week, with each session lasting 45 minutes. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of Autism Spectrum Disorder (ASD)
- Minimal verbal communication
- Age between 4 and 12 years.
Key exclusion criteria (3 listed)
- Presence of severe intellectual disability.
- Diagnosis of neurological disorders other than ASD.
- Significant medical conditions that could interfere with study participation.
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 |
|---|---|---|
| NAO-Assisted TherapyThe intervention sessions included tasks designed to engage the child in verbal and social interactions, such as naming objects, responding to questions, and performing gestures. The NAO robot provided consistent and predictable feedback, while therapists supported and reinforced appropriate communicative behaviors. | Behavioural | NAO-Assisted Intervention (Experimental Group EG) |
| Standard therapeuticStandard therapeutic approaches included exercises aimed at improving verbal communication and social engagement, such as naming objects, sentence construction, and comprehension tasks. Therapists adapted the intervention to the child's individual communication goals. | Behavioural | Standard Therapy (Control Group) |
Primary outcome
Language Development Level Test (TVL)
Time frame: T0(baseline)-T1(3months)
The Test of Verbalization and Language Development (TVL) is a standardized tool designed to assess various aspects of language development, including verbal production, comprehension, sentence construction, phonological accuracy, and morphosyntactic abilities. The weighted score ranges from 0 to 10, with higher scores indicating better language development.
The Child Behavior Checklist (CBCL)
Time frame: T0(baseline)-T1(3months)
The Child Behavior Checklist (CBCL) is a caregiver-reported questionnaire used to identify emotional and behavioral problems in children. It measures multiple domains, including emotional reactivity, anxiety, attention problems, and social difficulties. The T-scores do not have a specific range, but values between 50 and 70 are considered within the normal range, while 70 to 100 indicates clinical significance. Higher scores indicate greater behavioral problems.
Quality of Life in Autism Questionnaire (QoLA)
Time frame: T0(baseline)-T1(3months)
The Quality of Life in Autism Questionnaire (QoLA) is a standardized measure assessing the quality of life of parents of autistic children, focusing on emotional well-being, stress, and satisfaction with support services. The questionnaire consists of two parts: * Part A: Scores range from 28 to 140, with higher scores indicating a better perceived quality of life. * Part B: Scores range from 20 to 100, with higher scores indicating fewer problems for parents related to their child's ASD-related behaviors.
Repetitive Behavior Scale (RBS)
Time frame: T0(baseline)-T1(3months)
The Repetitive Behavior Scale-Revised (RBS-R) is a caregiver-reported questionnaire assessing restricted and repetitive behaviors in autistic children, including stereotyped behaviors, self-injury, and compulsive behaviors. Each behavior is rated on a 4-point Likert scale. Higher scores indicate greater severity of repetitive behaviors.
Strengths and Difficulties Questionnaire (SDQ)
Time frame: T0(baseline)-T1(3months)
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioral screening tool assessing emotional symptoms, conduct problems, hyperactivity, peer relationship problems, and prosocial behaviors in children aged 2-17 years. For all scales except the prosocial behavior scale, higher scores indicate greater levels of distress. In the prosocial behavior scale, higher scores indicate stronger positive social behaviors.
Conners' Parent Rating Scale (CPRS)
Time frame: T0(baseline)-T1(3months)
The Conners' Parent Rating Scale (CPRS) is a widely used research and clinical tool that gathers parental reports on childhood behavioral problems, particularly related to attention-deficit/hyperactivity disorder (ADHD) and associated behavioral concerns. T-scores above 70 indicate a higher likelihood of problematic behaviors and ADHD symptoms. Higher scores suggest greater severity of behavioral issues
Mand Requests During Sessions
Time frame: During Sessions
This observational measure tracks and records the number of spontaneous and prompted requests initiated by the child to express needs or desires during therapy sessions. Frequency count per session. Higher frequencies indicate greater communicative initiative
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 11 Feb 2025.
- Background: PubMed 32206584Hodges H, Fealko C, Soares N. Autism spectrum disorder: definition, epidemiology, causes, and clinical evaluation. Transl Pediatr. 2020 Feb;9(Suppl 1):S55-S65. doi: 10.21037/tp.2019.09.09.
- Background: PubMed 27120989Rose V, Trembath D, Keen D, Paynter J. The proportion of minimally verbal children with autism spectrum disorder in a community-based early intervention programme. J Intellect Disabil Res. 2016 May;60(5):464-77. doi: 10.1111/jir.12284.
- Background: PubMed 30395694Brignell A, Chenausky KV, Song H, Zhu J, Suo C, Morgan AT. Communication interventions for autism spectrum disorder in minimally verbal children. Cochrane Database Syst Rev. 2018 Nov 5;11(11):CD012324. doi: 10.1002/14651858.CD012324.pub2.
- Background: PubMed 33983864Korneder J, Louie WG, Pawluk CM, Abbas I, Brys M, Rooney F. Robot-mediated interventions for teaching children with ASD: A new intraverbal skill. Assist Technol. 2022 Nov 2;34(6):707-716. doi: 10.1080/10400435.2021.1930284. Epub 2021 May 28.
- Background: PubMed 33862066Salimi Z, Jenabi E, Bashirian S. Are social robots ready yet to be used in care and therapy of autism spectrum disorder: A systematic review of randomized controlled trials. Neurosci Biobehav Rev. 2021 Oct;129:1-16. doi: 10.1016/j.neubiorev.2021.04.009. Epub 2021 Apr 20.
- 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.
Margherita La Fauci principal investigator
IRCCS Centro Neurolesi Bonino Pulejo
Maria Tresoldi principal investigator
University Hospital "G. Martino"
Marcella Di Cara principal investigator
IRCCS Centro Neurolesi Bonino Pulejo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAO-Assisted Therapy and Standard therapeutic in people with Autism Spectrum Disorder, run by IRCCS Centro Neurolesi Bonino Pulejo 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 3 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: enrolling by invitation, as of the sponsor's last update on 11 Feb 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?
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?
Language Development Level Test (TVL) (time frame: T0(baseline)-T1(3months)). The study lists 7 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 NCT06805916, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.