Dyslexia, DevelopmentalBEATLENCT06713863
Intervention Effectiveness Study of BEtter AT LEarning (BEATLE)- Digital Neuropsychological Rehabilitation Program
A study testing BEtter AT LEarning (BEATLE)- Digital Care Pathway in people with Dyslexia, Developmental and Developmental Language Disorder, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
The purpose of this study is to evaluate the effectiveness of BEATLE with clinical samples of patients diagnosed with Developmental Language Disorder (DLD), Dyslexia, and Mixed Specific Developmental Disorder. A randomized controlled trial with a waitlist design will be employed. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia, Developmental, Developmental Language Disorder, Specific Learning Disorder
- What is being tested?
- BEtter AT LEarning (BEATLE)- Digital Care Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 2 sitesFinland
- Study dates
- 1 May 2025to Apr 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- All exclusion criteria will be addressed individually. If a respondent fulfills one or more of the exclusion criteria, the respondent will be dropped out. Exclusion criteria are formed as follows:
- Suspicion of mild intellectual disability Both verbal and non-verbal reasoning skills more than two standard deviations lower than average (VCI \& PRI < 70) Weak (-2 Standard Deviations) performance on both subtests representing fluid intelligence (Wechsler's Intelligence Scale for Children IV (WISC-IV): Matrix reasoning and Picture concepts)
- Diagnosis of Autism Spectrum Disorder
- Untreated Attention-Deficit Hyperactivity Disorder
- Unable to adequately use a a computer and/or a smartphone
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Pediatric Neurology, Helsinki University Hospital
Helsinki
Markus S. Hannukkala, PhD Student, M.A., +358407057351, samuel.hannukkala@hus.fi
- Recruiting
Phoniatrics, Helsinki University Hospital
Helsinki
Sari Levänen, PhD, +358504287228, Sari-anne.levanen@hus.fi
About this study
The purpose of this study is to evaluate the effectiveness of BEATLE with clinical samples of patients diagnosed with Developmental Language Disorder (DLD), Dyslexia, and Mixed Specific Developmental Disorder. A randomized controlled trial with a waitlist design will be employed. The objective is to assess potential changes in perceived self-efficacy, self-compassion, executive functioning, and attitudes toward learning as reported by the participants, their guardians (parents), and teachers. Additionally, this study aims to examine the correlation between the usage of the Digital Care Pathway (DCP) and its effectiveness.
Read the detailed description
BEATLE (BEtter AT LEarning) is a neuropsychological digital rehabilitative program (Digital Care Pathway, DCP) developed at the Department of Phoniatrics, University Hospital of Helsinki and Uusimaa region (HUS). The purpose of this DCP is to provide knowledge on meta-skills and tools for learning to 12-16-year-olds who experience learning difficulties due to developmental language disorder, dyslexia, or other developmental issues.
The aforementioned developmental disorders can have long-lasting impacts on individuals' lives. For instance, children with DLD have been reported to have a lower quality of life than typically developing children, according to parent evaluations. Self-evaluation is a crucial aspect of individual performance and well-being. Albert Bandura's social cognitive theory posits that individuals are proactive and reflective beings who simultaneously shape and are shaped by their environment (Reciprocal Determinism). According to Bandura, individuals constantly evaluate and form beliefs about their capabilities to perform in given situations (Self-efficacy). The theory of self-efficacy is often employed in educational sciences, where students with higher self-efficacy beliefs have been found to exert more effort in schoolwork, perform better academically, and have a more positive attitude toward school. Primary school students with specific learning difficulties have been reported to have lower self-efficacy beliefs than their peers.
Another perspective on self-evaluation and perception of difficulties can be explored through the concept of self-compassion. Neff defines self-compassion as a multifaceted construct that encompasses how individuals emotionally respond to suffering, cognitively understand their predicament, and pay attention to their suffering. A longitudinal study found that ninth-grade students with low self-esteem but high self-compassion exhibited better psychological health one year later compared to those with low self-compassion. Self-compassion has demonstrated its utility as a framework for interventions.
The aim of BEATLE is to provide understanding, inspiration, and tools for better learning in adolescents. This study aims to (1) analyze the effectiveness and feasibility of the BEATLE online rehabilitative course in three clinical groups (DLD, Dyslexia, and Mixed Specific Developmental Disorder) and (2) explore the potential differences in effectiveness among these diagnostic groups. For example, participants with dyslexia may report better and more lasting outcomes than participants with DLD or Mixed Specific Developmental Disorder, considering that the DCP includes several strategies for using digital tools such as dictation and text-to-speech, which can aid with primary difficulties related to reading and writing.
The study will employ a randomized controlled trial with a waitlist design. The objective is to assess potential changes in perceived self-efficacy, self-compassion, executive functioning, and attitudes toward learning as reported by participants, guardians (parents), and teachers. Additionally, this study aims to examine the correlation between the usage of the DCP and its effectiveness.
Participants will be recruited from 12-16-year-old patients referred to HUS Phoniatrics or HUS Pediatric Neurology. The target sample size is 52 participants per group (26 in the intervention group and 26 in the waitlist group), totaling 156 complete participants. Accounting for a conservative dropout rate of 50%, up to 312 participants may be required for recruitment. Another digital health program (DHP) on acquired brain injury patients in adults has reported a dropout rate of approximately 20%.
Recruitment will be conducted by neuropsychologists at respective clinics. After expressing willingness to participate, participants and their guardians will sign consent forms. Participants will then receive an envelope containing study materials and a consent form for their teacher to sign. Participation in the study does not supersede any other treatment.
Signed consent forms will be submitted to the research team, after which participants will be randomized into either the intervention group or the waitlist group. Randomization will be conducted in RedCap to minimize the risk of bias. Participants in the intervention group will receive an invitation to the DCP a few days after signing the agreement and completing the pre-intervention questionnaires. Participants in the waitlist group will first complete baseline questionnaires and will then wait 10 weeks before entering the cross-over phase and receiving access to the DCP.
- Conditions
- Dyslexia, Developmental, Developmental Language Disorder, Specific Learning Disorder, Borderline Intellectual Functioning
- Being tested
- BEtter AT LEarning (BEATLE)- Digital Care Pathway
- Keywords
- eHealth, Adolescence, Intervention, Effectiveness, RCT
- Medical subject headings
- Dyslexia, Language Development Disorders, Specific Learning Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEtter AT LEarning (BEATLE)- Digital Care PathwayOther
BEATLE is a digital care pathway consisting of ten episodes resembling an online course. The episodes are designed to be multimodal and immersive, incorporating text, recorded voice, pictures, cartoons, videos and peer support through given examples and case stories. Participants are encouraged to access BEATLE through a web browser on a computer, although it is also accessible through a mobile application. Participants have control over the pace of completing the BEATLE, but there must be a minimum five-day break between episodes. In other words, it is possible to complete the BEATLE in seven weeks.
All participants are referred to the BEATLE by a neuropsychologist and are strongly authenticated in the healthvillage.fi online platform. Each participant is assigned a designated neuropsychologist who tracks their progress in the BEATLE and to whom messages and questions can be sent by the participant.
| Study group | Role | What they receive |
|---|---|---|
| Intervention first | Experimental | Participant directly enrolled to the intervention Receives: Other: BEtter AT LEarning (BEATLE)- Digital Care Pathway |
| Waitlist first | No intervention | Participant spends amount of time similar to completing the intervention in a waitlist after which gets enrolled into the intervention after post-waitlist measures have been completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy Questionnaire for Children and Adolescents (SEQ-C)
A brief questionnaire assessing perceived academic, emotional and social self-efficacy. Scale scores will be calulated for academic (Min 8 - Max 40), emotional ( Min 7 - 35) and social self-efficacy (Min 8 - Max 40). A total self-efficacy score will also be calculated as a sum of abovementioned three scale scores (Min 23 - Max 115).
Measured: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.
Sussex-Oxford Compassion Scale - Self (SOCS-S)
A brief questionnaire intended to measure perceived self-compassion. The measure consists of 20 items that are answered on 5-step likert scale. Five scale sum scores will be calculated from the measure: Recognition of suffering (Min 4 - Max 20), Understanding the universality of suffering (Min 4 - Max 20), Feeling sympathy for those who are suffering (Min 4 - Max 20), Tolerating the distress associated with the witnessing of suffering (Min 4 - Max 20) and Motivation to act to alleviate the suffering (Min 4 - Max 20). A total self-compassion score will also be calculated that is the sum of above mentioned five scale scores (Min 20 - Max 100).
Measured: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.
Secondary outcomes (2)
5-15
5-15 is a questionnaire designed to assess perceived difficulties in children or adolescents. Parents and teachers of the participant will fill parts of this survey regarding executive functioning and learning. All items are answered on a three-step scale from 0 to 2.
Following scale sum variables will be calculated:
Reading, writing, calculating (13 items: MIN 0 - MAX 26), Learning and participation in learning (6 items: MIN 0 - MAX 12), Problem solving in learning situations (10 items: MIN 0 - MAX 20).
Measured: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.
The Strengths and Difficulties Questionnaire (SDQ)
The Strengths and Difficulties Questionnaire is a brief behavioural screening questionnaire about 2-17 year olds. Parent and teacher of the participant is given SDQ to be filled in different timepoints of the study. SDQ consists of 25 symptom items that are answered on three-step scale from 0 to 2 and provide five scale sum scores to be calculated: Emotional difficulties scale (MIN 0 - MAX 10), Conduct difficulties scale (MIN 0 - MAX 10), Hyperactivity scale (MIN 0 - MAX 10), Peer difficulties scale (MIN 0 - MAX 10), Prosocial Scale (MIN 0 - MAX 10). A total difficulties score is also calculated by summing scores from all symptom scales except the prosocial scale (MIN 0 - MAX 40). Internalizing score ranges from 0 to 20 and is the sum of emotional and peer difficulties scales. The externalizing score ranges from 0 to 20 and is the sum of the conduct and hyperactivity scales.
Measured: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 May 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyslexia, DevelopmentalStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sari-Anne Levänen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713863
- Sponsor's protocol ID
- HUS/6774/2023
- Acronym
- BEATLE
- Status last verified
- Mar 2025
- First submitted
- 27 Nov 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are in favor of sharing anonymized individual participant data (IPD) collected in this study. However, the process for data sharing is still under review, and guidance is being sought on the permitted methods for making anonymized data available. Once the regulatory and institutional guidelines are clarified, a decision will be made regarding the extent and format of data sharing. If data sharing is approved, details on access procedures, including any necessary agreements or repositories used, will be provided in the study record.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effectiveness Study of BEtter AT LEarning (BEATLE)- Digital Neuropsychological Rehabilitation Program
- ClinicalTrials.gov ID
- NCT06713863
- Acronym / sponsor ID
- BEATLE / HUS/6774/2023
- Conditions
- Dyslexia, Developmental, Developmental Language Disorder, Specific Learning Disorder, Borderline Intellectual Functioning
- Keywords
- eHealth, Adolescence, Intervention, Effectiveness, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 3 Dec 2024 (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 purpose of this study is to evaluate the effectiveness of BEATLE with clinical samples of patients diagnosed with Developmental Language Disorder (DLD), Dyslexia, and Mixed Specific Developmental Disorder. A randomized controlled trial with a waitlist design will be employed. The objective is to assess potential changes in perceived self-efficacy, self-compassion, executive functioning, and attitudes toward learning as reported by the participants, their guardians (parents), and teachers. Additionally, this study aims to examine the correlation between the usage of the Digital Care Pathway (DCP) and its effectiveness.
Detailed description
BEATLE (BEtter AT LEarning) is a neuropsychological digital rehabilitative program (Digital Care Pathway, DCP) developed at the Department of Phoniatrics, University Hospital of Helsinki and Uusimaa region (HUS). The purpose of this DCP is to provide knowledge on meta-skills and tools for learning to 12-16-year-olds who experience learning difficulties due to developmental language disorder, dyslexia, or other developmental issues.
The aforementioned developmental disorders can have long-lasting impacts on individuals' lives. For instance, children with DLD have been reported to have a lower quality of life than typically developing children, according to parent evaluations. Self-evaluation is a crucial aspect of individual performance and well-being. Albert Bandura's social cognitive theory posits that individuals are proactive and reflective beings who simultaneously shape and are shaped by their environment (Reciprocal Determinism). According to Bandura, individuals constantly evaluate and form beliefs about their capabilities to perform in given situations (Self-efficacy). The theory of self-efficacy is often employed in educational sciences, where students with higher self-efficacy beliefs have been found to exert more effort in schoolwork, perform better academically, and have a more positive attitude toward school. Primary school students with specific learning difficulties have been reported to have lower self-efficacy beliefs than their peers.
Another perspective on self-evaluation and perception of difficulties can be explored through the concept of self-compassion. Neff defines self-compassion as a multifaceted construct that encompasses how individuals emotionally respond to suffering, cognitively understand their predicament, and pay attention to their suffering. A longitudinal study found that ninth-grade students with low self-esteem but high self-compassion exhibited better psychological health one year later compared to those with low self-compassion. Self-compassion has demonstrated its utility as a framework for interventions.
The aim of BEATLE is to provide understanding, inspiration, and tools for better learning in adolescents. This study aims to (1) analyze the effectiveness and feasibility of the BEATLE online rehabilitative course in three clinical groups (DLD, Dyslexia, and Mixed Specific Developmental Disorder) and (2) explore the potential differences in effectiveness among these diagnostic groups. For example, participants with dyslexia may report better and more lasting outcomes than participants with DLD or Mixed Specific Developmental Disorder, considering that the DCP includes several strategies for using digital tools such as dictation and text-to-speech, which can aid with primary difficulties related to reading and writing.
The study will employ a randomized controlled trial with a waitlist design. The objective is to assess potential changes in perceived self-efficacy, self-compassion, executive functioning, and attitudes toward learning as reported by participants, guardians (parents), and teachers. Additionally, this study aims to examine the correlation between the usage of the DCP and its effectiveness.
Participants will be recruited from 12-16-year-old patients referred to HUS Phoniatrics or HUS Pediatric Neurology. The target sample size is 52 participants per group (26 in the intervention group and 26 in the waitlist group), totaling 156 complete participants. Accounting for a conservative dropout rate of 50%, up to 312 participants may be required for recruitment. Another digital health program (DHP) on acquired brain injury patients in adults has reported a dropout rate of approximately 20%.
Recruitment will be conducted by neuropsychologists at respective clinics. After expressing willingness to participate, participants and their guardians will sign consent forms. Participants will then receive an envelope containing study materials and a consent form for their teacher to sign. Participation in the study does not supersede any other treatment.
Signed consent forms will be submitted to the research team, after which participants will be randomized into either the intervention group or the waitlist group. Randomization will be conducted in RedCap to minimize the risk of bias. Participants in the intervention group will receive an invitation to the DCP a few days after signing the agreement and completing the pre-intervention questionnaires. Participants in the waitlist group will first complete baseline questionnaires and will then wait 10 weeks before entering the cross-over phase and receiving access to the DCP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention first | Experimental | Other: BEtter AT LEarning (BEATLE)- Digital Care PathwayParticipant directly enrolled to the intervention |
| Waitlist first | No intervention | –Participant spends amount of time similar to completing the intervention in a waitlist after which gets enrolled into the intervention after post-waitlist measures have been completed. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- All exclusion criteria will be addressed individually. If a respondent fulfills one or more of the exclusion criteria, the respondent will be dropped out. Exclusion criteria are formed as follows:
- Suspicion of mild intellectual disability Both verbal and non-verbal reasoning skills more than two standard deviations lower than average (VCI \& PRI < 70) Weak (-2 Standard Deviations) performance on both subtests representing fluid intelligence (Wechsler's Intelligence Scale for Children IV (WISC-IV): Matrix reasoning and Picture concepts)
- Diagnosis of Autism Spectrum Disorder
- Untreated Attention-Deficit Hyperactivity Disorder
- Unable to adequately use a a computer and/or a smartphone
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 |
|---|---|---|
| BEtter AT LEarning (BEATLE)- Digital Care PathwayBEATLE is a digital care pathway consisting of ten episodes resembling an online course. The episodes are designed to be multimodal and immersive, incorporating text, recorded voice, pictures, cartoons, videos and peer support through given examples and case stories. Participants are encouraged to access BEATLE through a web browser on a computer, although it is also accessible through a mobile application. Participants have control over the pace of completing the BEATLE, but there must be a minimum five-day break between episodes. In other words, it is possible to complete the BEATLE in seven weeks. All participants are referred to the BEATLE by a neuropsychologist and are strongly authenticated in the healthvillage.fi online platform. Each participant is assigned a designated neuropsychologist who tracks their progress in the BEATLE and to whom messages and questions can be sent by the participant. | Other | Intervention first |
Primary outcome
Self-Efficacy Questionnaire for Children and Adolescents (SEQ-C)
Time frame: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.
A brief questionnaire assessing perceived academic, emotional and social self-efficacy. Scale scores will be calulated for academic (Min 8 - Max 40), emotional ( Min 7 - 35) and social self-efficacy (Min 8 - Max 40). A total self-efficacy score will also be calculated as a sum of abovementioned three scale scores (Min 23 - Max 115).
Sussex-Oxford Compassion Scale - Self (SOCS-S)
Time frame: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.
A brief questionnaire intended to measure perceived self-compassion. The measure consists of 20 items that are answered on 5-step likert scale. Five scale sum scores will be calculated from the measure: Recognition of suffering (Min 4 - Max 20), Understanding the universality of suffering (Min 4 - Max 20), Feeling sympathy for those who are suffering (Min 4 - Max 20), Tolerating the distress associated with the witnessing of suffering (Min 4 - Max 20) and Motivation to act to alleviate the suffering (Min 4 - Max 20). A total self-compassion score will also be calculated that is the sum of above mentioned five scale scores (Min 20 - Max 100).
2 secondary outcomes
5-15
Time frame: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.
The Strengths and Difficulties Questionnaire (SDQ)
Time frame: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.
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 8 May 2025.
- Individual participant dataSharing planned: Undecided. The investigators are in favor of sharing anonymized individual participant data (IPD) collected in this study. However, the process for data sharing is still under review, and guidance is being sought on the permitted methods for making anonymized data available. Once the regulatory and institutional guidelines are clarified, a decision will be made regarding the extent and format of data sharing. If data sharing is approved, details on access procedures, including any necessary agreements or repositories used, will be provided in the study record.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEtter AT LEarning (BEATLE)- Digital Care Pathway in people with Dyslexia, Developmental and Developmental Language Disorder, run by Helsinki University Central Hospital at 2 sites in Finland.
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 0 inclusion and 5 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 8 May 2025. 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 Finland. 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 Markus S. Hannukkala, PhD Student, M.A. (+358407057351, samuel.hannukkala@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy Questionnaire for Children and Adolescents (SEQ-C) (time frame: Filled three to four times in different phases of the study. Both arms fill the measure before the intervention, after intervention and three months after the intervention. Waitlist- arm also fills the measure on the start of the waitlist period.). The study lists 2 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 8 May 2025.