Attention Deficit Hyperactivity DisorderNCT04494230
Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities
An observational study of Attention Deficit Hyperactivity Disorder and Comorbidities and Coexisting Conditions, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In this study, aged 6-10 years, male, right hand dominant, diagnosed with ADHD, accepting to take part in the study and applying to the Child and Adolescent Psychiatry Department between October 1, 2018 - October 1, 2019 were included in the research group.As for the control group, boys between 6-10 years of age with… Read more about this study
- Who is it for?
- Ages 6 to 10 years, men only
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Comorbidities and Coexisting Conditions, Motor Skills Disorders
- What is being tested?
- Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 Oct 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- Men only
- Child
Study population: children aged 6-10 years, male, right hand dominant
Who may be able to join
- children aged 6-10 years, male, right hand dominant, diagnosed with ADHD, accepting to take part in the study and applying to the Child and Adolescent Psychiatry Department
Who cannot join
- with head trauma or known neurological disease, clinically diagnosed as comorbid tic disorder, obsessive-compulsive disorder, psychotic disorder, mood disorder, conduct disorder, mental retardation, or autism spectrum disorder, or children previously excluded from physical therapy program
Trial locations and contacts
1 site in 1 country.
About this study
In this study, aged 6-10 years, male, right hand dominant, diagnosed with ADHD, accepting to take part in the study and applying to the Child and Adolescent Psychiatry Department between October 1, 2018 - October 1, 2019 were included in the research group.As for the control group, boys between 6-10 years of age with no mental symptoms described by their teachers or parents and showing healthy development were selected by convenience sampling method and snow ball method. Height and weight measurements of all the children participated in the study were performed. The sociodemographic data form prepared by the researchers was completed by both the research and the control group families.
In the sample, the Corners' Parent Scale- Revised Short Form (CPS-R:SF) was used to evaluate the severity of ADHD symptoms.The hand preferences of all participants in the research and control groups were evaluated with Edinburgh Handedness Inventory.Motor skills were evaluated with the 2nd Version of Bruininsky-Oseretsky Motor Competence Test (BOT-2).Hand skills were evaluated with the 9-Hole Peg Test.Visual perception skills were evaluated with 3rd Version of Visual Perception Test without Motor Ability (MVPT-3). Pediatric Quality of Life Inventory Parent Form were filled by the parents of children in the research and control groups for quality of life. In the study, there are five groups: ADHD, ADHD + Specific learning disorders, ADHD + Oppositional defiant disorder, ADHD + Anxiety Disorder and children with typical development group.
Read the detailed description
In this study, aged 6-10 years, male, right hand dominant, diagnosed with ADHD, accepting to take part in the study and applying to the Child and Adolescent Psychiatry Department between October 1, 2018 - October 1, 2019 were included in the research group. A total of 106 children with head trauma or known neurological disease, clinically diagnosed as comorbid tic disorder, obsessive-compulsive disorder, psychotic disorder, mood disorder, conduct disorder, mental retardation, or autism spectrum disorder, or children previously excluded from physical therapy program were evaluated according to the research method. As for the control group; 30 boys between 6-10 years of age with no mental symptoms described by their teachers or parents and showing healthy development were selected by convenience sampling method and snow ball methodHeight and weight measurements of all the children participated in the study were performed. The sociodemographic data form prepared by the researchers was completed by both the research and the control group families.
In the sample, the Corners' Parent Scale- Revised Short Form (CPS-R:SF) was used to evaluate the severity of ADHD symptoms (Conners, 1997).
The hand preferences of all participants in the research and control groups were evaluated with Edinburgh Handedness Inventory.
Motor skills were evaluated with the 2nd Version of Bruininsky-Oseretsky Motor Competence Test (BOT-2). It is a standard test commonly used by physiotherapists to detect coarse and fine motor problems in children aged 4-21 years. It has both short and long form. The short form was used in our study. The short form of BOT-2 consists of 8 subtests: fine motor precision, fine motor integration, manual dexterity, bilateral coordination, balance, speed of movement and agility, upper extremity coordination and strength. Not only can the score of each subtest of the test be calculated separately but it can also be calculated as fine motor skill, gross motor skill, both fine and gross motor skill and total motor skill score.
Hand skills were evaluated with the 9-Hole Peg Test. The nine-hole Peg Test is a quick, simple and manual skill test that is particularly sensitive to changes in upper extremity performance. The test material consists of nine small rods made of standard sizes and nine perforated boards into which they are placed. In our study, insertion and removal periods for both dominant and nondominant hands were recorded separately.
Visual perception skills were evaluated with 3rd Version of Visual Perception Test without Motor Ability (MVPT-3). MVPT-3 is a fast, reliable test that tests visual perception without motor skills in children and adults (ages 4-65). The test consists of 65 questions and the first 40 questions were developed to test school-age children in terms of visual perception without motor skills as follows: visual discrimination (1-8), form constancy (9-13), visual memory-I (14-21), visual closure (22-34), visual differentiation (35-40). Total visual perception score and scores from each category were calculated separately. Pediatric Quality of Life Inventory Parent Form were filled by the parents of children in the research and control groups for quality of life. The scale has separate parent and child forms for the groups of 5-7 years, 8-12 years and 13-18 years. Scoring of the scale is done in 3 areas. Firstly, scale total score (STS) is calculated, and secondly, physical health total score (PHTS) is calculated. Thirdly, psychosocial health total score (PHTS) is calculated, which consists of calculating item scores evaluating emotional, social and school functionality. In the study, there are five groups: ADHD, ADHD + Specific learning disorders, ADHD + Oppositional defiant disorder, ADHD + Anxiety Disorder and children with typical development group.
- Conditions
- Attention Deficit Hyperactivity Disorder, Comorbidities and Coexisting Conditions, Motor Skills Disorders
- Being tested
- Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities
- Keywords
- Attention Deficit Hyperactivity Disorder, comorbidity, motor skills
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Proficiency in School Age ADHD: Contribution of Different ComorbiditiesBehavioural
to investigate whether motor skills, manual dexterity and visual perception differ in the presence of ADHD and comorbid psychiatric conditions in school-age boys by comparing them typical development children.
| Study group | Role | What they receive |
|---|---|---|
| Attention deficit hyperactivity disorder (ADHD) only | the diagnosis of ADHD Receives: Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities | |
| Attention deficit hyperactivity disorder (ADHD) andSpecificand | the diagnosis of ADHD and SLD Receives: Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities | |
| ADHD and oppositional defiant disorder (ODD) | the diagnosis of ADHD and ODD Receives: Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities | |
| ADHD and Anxiety Disorder | the diagnosis of ADHD and Ank. Dis. Receives: Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities | |
| Typical Development Children | no mental symptoms described by their teachers or parents and showing healthy development Receives: Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity ADHD symptoms
the Corners' Parent Scale- Revised Short Form (CPS-R:SF) was used to evaluate the severity of ADHD symptoms. The scale whose Turkish adaptation study was made by Kaner et al. (2006) consists of 27 items. In CPS-R:SF, questions are answered on a 4-point Likert scale and high scores indicate the intensity of symptoms.
Measured: 10 minutes
motor profiency
Motor skills were evaluated with the 2nd Version of Bruininsky-Oseretsky Motor Competence Test (BOT-2) (Bruininks, 1978). It is a standard test commonly used by physiotherapists to detect coarse and fine motor problems in children aged 4-21 years. It has both short and long form. The short form was used in our study. The short form of BOT-2 consists of 8 subtests: fine motor precision, fine motor integration, manual dexterity, bilateral coordination, balance, speed of movement and agility, upper extremity coordination and strength. Not only can the score of each subtest of the test be calculated separately but it can also be calculated as fine motor skill, gross motor skill, both fine and gross motor skill and total motor skill score.
Measured: 40-45 minutes
hand skills
Hand skills were evaluated with the 9-Hole Peg Test. This questionnaire questions a hand or both hands used in daily life activities such as writing, drawing, ball throwing, using scissors, using a toothbrush, using a fork-free knife, using a spoon, sweeping with a broom handle, burning matches and opening boxes
Measured: 10 minutes
visual perception
Visual perception skills were evaluated with 3rd Version of Visual Perception Test without Motor Ability (MVPT-3). MVPT-3 is a fast, reliable test that tests visual perception without motor skills in children and adults (ages 4-65). The test consists of 65 questions and the first 40 questions were developed to test school-age children in terms of visual perception without motor skills as follows: visual discrimination (1-8), form constancy (9-13), visual memory-I (14-21), visual closure (22-34), visual differentiation (35-40). Total visual perception score and scores from each category were calculated separately
Measured: 30 minutes
quality of life
Quality of life were evaluated with Pediatric Quality of Life Inventory (PedsQL) aims to measure the overall quality of life in the 2-18 age group. The scale has separate parent and child forms for the groups of 5-7 years, 8-12 years and 13-18 years. Scoring of the scale is done in 3 areas. Firstly, scale total score (STS) is calculated, and secondly, physical health total score (PHTS) is calculated. Thirdly, psychosocial health total score (PHTS) is calculated, which consists of calculating item scores evaluating emotional, social and school functionality. The higher the total score of the scale is, the better the quality of life related to health is perceived
Measured: 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Oct 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Şahan, Hacettepe University
- Investigators
- Nilay Şahan, PhD,PT, Principal investigator, unaffilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494230
- Sponsor's protocol ID
- GO 18/694
- Status last verified
- Oct 2018
- First submitted
- 28 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goulardins JB, Marques JC, De Oliveira JA. Attention Deficit Hyperactivity Disorder and Motor Impairment. Percept Mot Skills. 2017 Apr;124(2):425-440. doi: 10.1177/0031512517690607. Epub 2017 Jan 31.
PubMed 28361657
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities
- ClinicalTrials.gov ID
- NCT04494230
- Acronym / sponsor ID
- GO 18/694
- Conditions
- Attention Deficit Hyperactivity Disorder, Comorbidities and Coexisting Conditions, Motor Skills Disorders
- Keywords
- Attention Deficit Hyperactivity Disorder, comorbidity, motor skills
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 31 Jul 2020 (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.
In this study, aged 6-10 years, male, right hand dominant, diagnosed with ADHD, accepting to take part in the study and applying to the Child and Adolescent Psychiatry Department between October 1, 2018 - October 1, 2019 were included in the research group.As for the control group, boys between 6-10 years of age with no mental symptoms described by their teachers or parents and showing healthy development were selected by convenience sampling method and snow ball method. Height and weight measurements of all the children participated in the study were performed. The sociodemographic data form prepared by the researchers was completed by both the research and the control group families.
In the sample, the Corners' Parent Scale- Revised Short Form (CPS-R:SF) was used to evaluate the severity of ADHD symptoms.The hand preferences of all participants in the research and control groups were evaluated with Edinburgh Handedness Inventory.Motor skills were evaluated with the 2nd Version of Bruininsky-Oseretsky Motor Competence Test (BOT-2).Hand skills were evaluated with the 9-Hole Peg Test.Visual perception skills were evaluated with 3rd Version of Visual Perception Test without Motor Ability (MVPT-3). Pediatric Quality of Life Inventory Parent Form were filled by the parents of children in the research and control groups for quality of life. In the study, there are five groups: ADHD, ADHD + Specific learning disorders, ADHD + Oppositional defiant disorder, ADHD + Anxiety Disorder and children with typical development group.
Detailed description
In this study, aged 6-10 years, male, right hand dominant, diagnosed with ADHD, accepting to take part in the study and applying to the Child and Adolescent Psychiatry Department between October 1, 2018 - October 1, 2019 were included in the research group. A total of 106 children with head trauma or known neurological disease, clinically diagnosed as comorbid tic disorder, obsessive-compulsive disorder, psychotic disorder, mood disorder, conduct disorder, mental retardation, or autism spectrum disorder, or children previously excluded from physical therapy program were evaluated according to the research method. As for the control group; 30 boys between 6-10 years of age with no mental symptoms described by their teachers or parents and showing healthy development were selected by convenience sampling method and snow ball methodHeight and weight measurements of all the children participated in the study were performed. The sociodemographic data form prepared by the researchers was completed by both the research and the control group families.
In the sample, the Corners' Parent Scale- Revised Short Form (CPS-R:SF) was used to evaluate the severity of ADHD symptoms (Conners, 1997).
The hand preferences of all participants in the research and control groups were evaluated with Edinburgh Handedness Inventory.
Motor skills were evaluated with the 2nd Version of Bruininsky-Oseretsky Motor Competence Test (BOT-2). It is a standard test commonly used by physiotherapists to detect coarse and fine motor problems in children aged 4-21 years. It has both short and long form. The short form was used in our study. The short form of BOT-2 consists of 8 subtests: fine motor precision, fine motor integration, manual dexterity, bilateral coordination, balance, speed of movement and agility, upper extremity coordination and strength. Not only can the score of each subtest of the test be calculated separately but it can also be calculated as fine motor skill, gross motor skill, both fine and gross motor skill and total motor skill score.
Hand skills were evaluated with the 9-Hole Peg Test. The nine-hole Peg Test is a quick, simple and manual skill test that is particularly sensitive to changes in upper extremity performance. The test material consists of nine small rods made of standard sizes and nine perforated boards into which they are placed. In our study, insertion and removal periods for both dominant and nondominant hands were recorded separately.
Visual perception skills were evaluated with 3rd Version of Visual Perception Test without Motor Ability (MVPT-3). MVPT-3 is a fast, reliable test that tests visual perception without motor skills in children and adults (ages 4-65). The test consists of 65 questions and the first 40 questions were developed to test school-age children in terms of visual perception without motor skills as follows: visual discrimination (1-8), form constancy (9-13), visual memory-I (14-21), visual closure (22-34), visual differentiation (35-40). Total visual perception score and scores from each category were calculated separately. Pediatric Quality of Life Inventory Parent Form were filled by the parents of children in the research and control groups for quality of life. The scale has separate parent and child forms for the groups of 5-7 years, 8-12 years and 13-18 years. Scoring of the scale is done in 3 areas. Firstly, scale total score (STS) is calculated, and secondly, physical health total score (PHTS) is calculated. Thirdly, psychosocial health total score (PHTS) is calculated, which consists of calculating item scores evaluating emotional, social and school functionality. In the study, there are five groups: ADHD, ADHD + Specific learning disorders, ADHD + Oppositional defiant disorder, ADHD + Anxiety Disorder and children with typical development group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Attention deficit hyperactivity disorder (ADHD) only | – | Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbiditiesthe diagnosis of ADHD |
| Attention deficit hyperactivity disorder (ADHD) andSpecificand | – | Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbiditiesthe diagnosis of ADHD and SLD |
| ADHD and oppositional defiant disorder (ODD) | – | Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbiditiesthe diagnosis of ADHD and ODD |
| ADHD and Anxiety Disorder | – | Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbiditiesthe diagnosis of ADHD and Ank. Dis. |
| Typical Development Children | – | Behavioral: Motor Proficiency in School Age ADHD: Contribution of Different Comorbiditiesno mental symptoms described by their teachers or parents and showing healthy development |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- Male only
- Age groups
- Child
- Study population
- children aged 6-10 years, male, right hand dominant
Key inclusion criteria (1 listed)
- children aged 6-10 years, male, right hand dominant, diagnosed with ADHD, accepting to take part in the study and applying to the Child and Adolescent Psychiatry Department
Key exclusion criteria (1 listed)
- with head trauma or known neurological disease, clinically diagnosed as comorbid tic disorder, obsessive-compulsive disorder, psychotic disorder, mood disorder, conduct disorder, mental retardation, or autism spectrum disorder, or children previously excluded from physical therapy program
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 |
|---|---|---|
| Motor Proficiency in School Age ADHD: Contribution of Different Comorbiditiesto investigate whether motor skills, manual dexterity and visual perception differ in the presence of ADHD and comorbid psychiatric conditions in school-age boys by comparing them typical development children. | Behavioural | ADHD and Anxiety Disorder, ADHD and oppositional defiant disorder (ODD), Attention deficit hyperactivity disorder (ADHD) andSpecificand, Attention deficit hyperactivity disorder (ADHD) only, Typical Development Children |
Primary outcome
severity ADHD symptoms
Time frame: 10 minutes
the Corners' Parent Scale- Revised Short Form (CPS-R:SF) was used to evaluate the severity of ADHD symptoms. The scale whose Turkish adaptation study was made by Kaner et al. (2006) consists of 27 items. In CPS-R:SF, questions are answered on a 4-point Likert scale and high scores indicate the intensity of symptoms.
motor profiency
Time frame: 40-45 minutes
Motor skills were evaluated with the 2nd Version of Bruininsky-Oseretsky Motor Competence Test (BOT-2) (Bruininks, 1978). It is a standard test commonly used by physiotherapists to detect coarse and fine motor problems in children aged 4-21 years. It has both short and long form. The short form was used in our study. The short form of BOT-2 consists of 8 subtests: fine motor precision, fine motor integration, manual dexterity, bilateral coordination, balance, speed of movement and agility, upper extremity coordination and strength. Not only can the score of each subtest of the test be calculated separately but it can also be calculated as fine motor skill, gross motor skill, both fine and gross motor skill and total motor skill score.
hand skills
Time frame: 10 minutes
Hand skills were evaluated with the 9-Hole Peg Test. This questionnaire questions a hand or both hands used in daily life activities such as writing, drawing, ball throwing, using scissors, using a toothbrush, using a fork-free knife, using a spoon, sweeping with a broom handle, burning matches and opening boxes
visual perception
Time frame: 30 minutes
Visual perception skills were evaluated with 3rd Version of Visual Perception Test without Motor Ability (MVPT-3). MVPT-3 is a fast, reliable test that tests visual perception without motor skills in children and adults (ages 4-65). The test consists of 65 questions and the first 40 questions were developed to test school-age children in terms of visual perception without motor skills as follows: visual discrimination (1-8), form constancy (9-13), visual memory-I (14-21), visual closure (22-34), visual differentiation (35-40). Total visual perception score and scores from each category were calculated separately
quality of life
Time frame: 15-20 minutes
Quality of life were evaluated with Pediatric Quality of Life Inventory (PedsQL) aims to measure the overall quality of life in the 2-18 age group. The scale has separate parent and child forms for the groups of 5-7 years, 8-12 years and 13-18 years. Scoring of the scale is done in 3 areas. Firstly, scale total score (STS) is calculated, and secondly, physical health total score (PHTS) is calculated. Thirdly, psychosocial health total score (PHTS) is calculated, which consists of calculating item scores evaluating emotional, social and school functionality. The higher the total score of the scale is, the better the quality of life related to health is perceived
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Results publication: PubMed 28361657Goulardins JB, Marques JC, De Oliveira JA. Attention Deficit Hyperactivity Disorder and Motor Impairment. Percept Mot Skills. 2017 Apr;124(2):425-440. doi: 10.1177/0031512517690607. Epub 2017 Jan 31.
- 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. This study is not recruiting at the moment.
Nilay Şahan, PhD,PT principal investigator
unaffilliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder and Comorbidities and Coexisting Conditions, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2020. 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity ADHD symptoms (time frame: 10 minutes). The study lists 5 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 NCT04494230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.