Williams SyndromeNCT01132885
Defining the Brain Phenotype of Children With Williams Syndrome
An observational study of Williams Syndrome and Duplication, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Little is known about how the brain changes during childhood and adolescence, how genes affect this process, or how the brains of people with 7q11.23 genetic variation change during this period. Read more about this study
- Who is it for?
- Ages 5 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Williams Syndrome, Duplication
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2011to not given
- Phase
- Observational
- 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 5 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children with classic WS deletions, those with smaller deletions, and those with duplications of the WS region on chromosome band 7q11.23.
Who may be able to join
- For all participants, the following inclusion criteria will apply:
- Greater than 5 years old.
- Able to provide assent if below the age of 18, or consent if 18 years of age or older. Parents will provide consent for participants below the age of 18. For patients who do not have the capacity to provide informed consent, consent may be obtained from a guardian or the holder of the DPA.
- Additionally, 7q11.23 CNV participants must have a typical, 7q11.23 CNV or other genetic abnormality in the Williams syndrome critical region of chromosome 7q11.23, and control participants must have normal intelligence.
Who cannot join
- For all participants who will participate in MRI scanning, the following exclusion criteria will apply:
- Any chronic or acute medical condition severe enough to interfere with task performance or interpretation of MRI data.
- Any medication that might interfere with task performance or interpretation of MRI data.
- Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye or other body part, dental braces).
- Pregnancy (a urine pregnancy test will be performed prior to all MRI procedures for all females of child-bearing potential.
- NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.
- For parents who will undergo blood draws only, they will not be able to participate if they have a condition
- that would make collecting blood unsafe.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Defining the Brain Phenotype of Children With 7q11.23 Copy Number Variation, Including Williams Syndrome and 7q11.23 Duplication Syndrome
Background:
- Little is known about how the brain changes during childhood and adolescence, how genes affect this process, or how the brains of people with 7q11.23 genetic variation change during this period. Researchers are interested in using magnetic resonance imaging to study how the brain changes in healthy children and children with 7q11.23 genetic variation, including Williams syndrome and 7q11.23 duplication syndrome.
Read more
Objectives:
- To study developmental changes in the brains of healthy children and children who have been diagnosed with Williams syndrome,7q11.23 duplication syndrome, or other 7q11.23 genetic variation.
Eligibility:
- Healthy children and adolescents between 5 and 17 years of age.
- Children and adolescents between 5 and 17 years of age who have been diagnosed with Williams syndrome, 7q11.23 duplication syndrome, or have other 7q11.23 genetic variation.
Design:
- Participants will have a brief physical examination and tests of memory, attention, concentration, and thinking. Parents will be asked about their child s personality, behavior characteristics, and social interaction and communication skills.
- Both participants and their parents may be asked to complete additional questionnaires or take various tests as required for the study.
- Participants will have approximately 10 hours of magnetic resonance imaging (MRI) scanning, usually over 4 to 5 days, within a one month period. Some of these tests will require the participants to do specific tasks while inside the MRI scanner.
- Participants will be asked to return to the National Institutes of Health clinical center to repeat these procedures every 2 years thereafter until age 18.
Read the detailed description
Williams syndrome is a rare disorder caused by hemizygous microdeletion of approximately 1.6 megabases on chromosomal band 7q11.23, typically by spontaneous mutation. The disorder is characterized by a collection of unique neuropsychiatric manifestations, including marked visuospatial construction deficits and hypersociability. Because the genes involved in WS are known, the study of neural mechanisms in WS affords a privileged setting for investigating genetic influences on complex brain functions in a bottom-up way.
Previous neuroimaging studies of adults with Williams syndrome resulted in a clear delineation of the Williams syndrome brain phenotype. Underlying the syndrome s cognitive hallmark, visuospatial construction impairment, is a neurostructural anomaly (decreased gray matter volume) and adjacent abnormal neural function in the parietal sulcus region of the dorsal visual processing stream. Subtle structural hippocampal alterations, along with abnormalities in regional cerebral blood flow, neurofunctional activation, and N-acetyl aspartate concentration also contribute to the visuospatial phenotype. Underlying the syndrome s social cognition features are structural and functional abnormalities in the orbitofrontal cortex, an important affect and social regulatory region that participates in a fronto-amygdala regulatory network found to be dysfunctional in Williams syndrome.
The findings in adult Williams syndrome patients have created a paradigm for identifying brain phenotypes linked to specific genes and for guiding research aimed at understanding the mechanism by which gene effects are translated in the brain to clinical phenomena. However, it is clear that the cognitive and behavioral disturbances in Williams syndrome emerge over the course of childhood and adolescence from a complex interplay of altered neural systems, which must be studied from a developmental and translational perspective. To meet this imperative, we propose a cross-sectional and longitudinal neuroimaging study of children with Williams syndrome to track the emergence and modification of the altered neural circuitry observed in the adult population. With non-invasive multimodal magnetic resonance imaging including structural MRI, functional MRI (fMRI), and diffusion tensor MRI-we propose to target those neural systems associated with key clinical features (e.g. visuospatial construction impairment and abnormal social cognition). We will employ experimental methods previously successful in assessing cognitive and emotional processing in the adult population. For neurofunctional studies, each task paradigm is optimized to provide adequate statistical power for single subject mapping, and to be amenable for young children. Additionally, structural MRI studies will allow for in depth tracking of structural changes, including changes in gray-white matter ratios and the integrity of white matter tracts throughout the brain. Blood samples for genetic analysis will be collected. One hundred children with classic Williams syndrome deletions, those with smaller deletions, and those with duplications, along with 50 of their unaffected siblings, will be studied at the NIH Clinical Center at two-year intervals for repeat neuroimaging studies. Additionally, approximately 115 unrelated, healthy children will also be studied. fMRI tasks will be piloted on fifteen of the latter. We will continue to study the children enrolled in this protocol after they turn 18 in order to determine the developmental trajectory of brain structure and function from childhood through adulthood. Additionally, fifty adults with classic Williams syndrome deletions, those with smaller deletions, and those with duplications will be studied at the NIH Clinical Center at two-year intervals for repeat neuroimaging studies in order to establish good adult end-points for our imaging protocol. Studying adults with WS and abnormalities of the WS genetic region with the same tasks and scanner as used for children will allow us to establish an adult WS comparison group against which children can be directly compared and also allow us to better determine the maturation of neural structure and function in WS through adulthood. Typically developing children whom we will continue to study after they turn 18 will serve as the control comparison group for adults with Williams syndrome .
Primary outcome measures include size and integrity of grey and white matter; functional MRI BOLD responses during rest, cognitive and emotion information processing; DTI anisotropy measures of white matter tracts; tissue perfusion (blood flow) measured with arterial spin labeling (ASL); and mcDespot myelin water fraction.
Secondary outcome measures include relationship of neuropsychological assessments and genotyping to the imaging results.
Our prior success in delineating the brain phenotype in adult Williams syndrome patients will provide the crucial context within which to view the emergence and modification of these neural circuit abnormalities from a developmental perspective in children with Williams syndrome and from which to launch translational studies of specific gene effects on brain and behavioral phenotypes.
- Conditions
- Williams Syndrome, Duplication
- Keywords
- MRI, Developmental, Genetic abnormalities in chromosome 7q11.23., Duplication, Brain, Natural History, Williams Syndrome, Children, Healthy Volunteer, HV
- Medical subject headings
- Williams Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with WS or genetic abnormalities | Adults with Williams syndrome or genetic abnormalities in chromosome 7q11.23 | |
| Children with WS or genetic abnormalities | children ages 5-17 with Williams Syndrome or genetic abnormalities in chromosome 7q11.23 | |
| Parents | Parents of children with 7q11.23 CNV will undergo blood draws | |
| Unaffected Siblings | Siblings of children with 7q11.23 CNV | |
| Unrelated children | Typically developing children ages ages 5-17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI Task Procedures
fMRI Task Procedures
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study start23 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Williams SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 415 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Karen F Berman, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132885
- Sponsor's protocol ID
- 100112
- Other IDs
- 10-M-0112
- Status last verified
- 1 Oct 2026
- First submitted
- 27 May 2010
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adolphs R, Tranel D, Damasio H, Damasio AR. Fear and the human amygdala. J Neurosci. 1995 Sep;15(9):5879-91. doi: 10.1523/JNEUROSCI.15-09-05879.1995.
PubMed 7666173Ashburner J. A fast diffeomorphic image registration algorithm. Neuroimage. 2007 Oct 15;38(1):95-113. doi: 10.1016/j.neuroimage.2007.07.007. Epub 2007 Jul 18.
PubMed 17761438Atkinson J, Braddick O, Rose FE, Searcy YM, Wattam-Bell J, Bellugi U. Dorsal-stream motion processing deficits persist into adulthood in Williams syndrome. Neuropsychologia. 2006;44(5):828-33. doi: 10.1016/j.neuropsychologia.2005.08.002. Epub 2005 Sep 15.
PubMed 16168445Kippenhan JS, Gregory MD, Nash T, Kohn P, Mervis CB, Eisenberg DP, Garvey MH, Roe K, Morris CA, Kolachana B, Pani AM, Sorcher L, Berman KF. Dorsal visual stream and LIMK1: hemideletion, haplotype, and enduring effects in children with Williams syndrome. J Neurodev Disord. 2023 Aug 26;15(1):29. doi: 10.1186/s11689-023-09493-x.
PubMed 37633900Chen G, Nash TA, Cole KM, Kohn PD, Wei SM, Gregory MD, Eisenberg DP, Cox RW, Berman KF, Shane Kippenhan J. Beyond linearity in neuroimaging: Capturing nonlinear relationships with application to longitudinal studies. Neuroimage. 2021 Jun;233:117891. doi: 10.1016/j.neuroimage.2021.117891. Epub 2021 Mar 3.
PubMed 33667672Gregory MD, Kolachana B, Yao Y, Nash T, Dickinson D, Eisenberg DP, Mervis CB, Berman KF. A method for determining haploid and triploid genotypes and their association with vascular phenotypes in Williams syndrome and 7q11.23 duplication syndrome. BMC Med Genet. 2018 Apr 4;19(1):53. doi: 10.1186/s12881-018-0563-3.
PubMed 29614955
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Brain Phenotype of Children With 7q11.23 Copy Number Variation, Including Williams Syndrome and 7q11.23 Duplication Syndrome
- ClinicalTrials.gov ID
- NCT01132885
- Acronym / sponsor ID
- 100112
- Conditions
- Williams Syndrome, Duplication
- Keywords
- MRI, Developmental, Genetic abnormalities in chromosome 7q11.23., Duplication, Brain, Natural History, Williams Syndrome, Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 415 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 23 Jan 2011 (actual)
- First posted
- 28 May 2010 (estimated)
- 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.
Background:
- Little is known about how the brain changes during childhood and adolescence, how genes affect this process, or how the brains of people with 7q11.23 genetic variation change during this period. Researchers are interested in using magnetic resonance imaging to study how the brain changes in healthy children and children with 7q11.23 genetic variation, including Williams syndrome and 7q11.23 duplication syndrome.
Objectives:
- To study developmental changes in the brains of healthy children and children who have been diagnosed with Williams syndrome,7q11.23 duplication syndrome, or other 7q11.23 genetic variation.
Eligibility:
- Healthy children and adolescents between 5 and 17 years of age.
- Children and adolescents between 5 and 17 years of age who have been diagnosed with Williams syndrome, 7q11.23 duplication syndrome, or have other 7q11.23 genetic variation.
Design:
- Participants will have a brief physical examination and tests of memory, attention, concentration, and thinking. Parents will be asked about their child s personality, behavior characteristics, and social interaction and communication skills.
- Both participants and their parents may be asked to complete additional questionnaires or take various tests as required for the study.
- Participants will have approximately 10 hours of magnetic resonance imaging (MRI) scanning, usually over 4 to 5 days, within a one month period. Some of these tests will require the participants to do specific tasks while inside the MRI scanner.
- Participants will be asked to return to the National Institutes of Health clinical center to repeat these procedures every 2 years thereafter until age 18.
Detailed description
Williams syndrome is a rare disorder caused by hemizygous microdeletion of approximately 1.6 megabases on chromosomal band 7q11.23, typically by spontaneous mutation. The disorder is characterized by a collection of unique neuropsychiatric manifestations, including marked visuospatial construction deficits and hypersociability. Because the genes involved in WS are known, the study of neural mechanisms in WS affords a privileged setting for investigating genetic influences on complex brain functions in a bottom-up way.
Previous neuroimaging studies of adults with Williams syndrome resulted in a clear delineation of the Williams syndrome brain phenotype. Underlying the syndrome s cognitive hallmark, visuospatial construction impairment, is a neurostructural anomaly (decreased gray matter volume) and adjacent abnormal neural function in the parietal sulcus region of the dorsal visual processing stream. Subtle structural hippocampal alterations, along with abnormalities in regional cerebral blood flow, neurofunctional activation, and N-acetyl aspartate concentration also contribute to the visuospatial phenotype. Underlying the syndrome s social cognition features are structural and functional abnormalities in the orbitofrontal cortex, an important affect and social regulatory region that participates in a fronto-amygdala regulatory network found to be dysfunctional in Williams syndrome.
The findings in adult Williams syndrome patients have created a paradigm for identifying brain phenotypes linked to specific genes and for guiding research aimed at understanding the mechanism by which gene effects are translated in the brain to clinical phenomena. However, it is clear that the cognitive and behavioral disturbances in Williams syndrome emerge over the course of childhood and adolescence from a complex interplay of altered neural systems, which must be studied from a developmental and translational perspective. To meet this imperative, we propose a cross-sectional and longitudinal neuroimaging study of children with Williams syndrome to track the emergence and modification of the altered neural circuitry observed in the adult population. With non-invasive multimodal magnetic resonance imaging including structural MRI, functional MRI (fMRI), and diffusion tensor MRI-we propose to target those neural systems associated with key clinical features (e.g. visuospatial construction impairment and abnormal social cognition). We will employ experimental methods previously successful in assessing cognitive and emotional processing in the adult population. For neurofunctional studies, each task paradigm is optimized to provide adequate statistical power for single subject mapping, and to be amenable for young children. Additionally, structural MRI studies will allow for in depth tracking of structural changes, including changes in gray-white matter ratios and the integrity of white matter tracts throughout the brain. Blood samples for genetic analysis will be collected. One hundred children with classic Williams syndrome deletions, those with smaller deletions, and those with duplications, along with 50 of their unaffected siblings, will be studied at the NIH Clinical Center at two-year intervals for repeat neuroimaging studies. Additionally, approximately 115 unrelated, healthy children will also be studied. fMRI tasks will be piloted on fifteen of the latter. We will continue to study the children enrolled in this protocol after they turn 18 in order to determine the developmental trajectory of brain structure and function from childhood through adulthood. Additionally, fifty adults with classic Williams syndrome deletions, those with smaller deletions, and those with duplications will be studied at the NIH Clinical Center at two-year intervals for repeat neuroimaging studies in order to establish good adult end-points for our imaging protocol. Studying adults with WS and abnormalities of the WS genetic region with the same tasks and scanner as used for children will allow us to establish an adult WS comparison group against which children can be directly compared and also allow us to better determine the maturation of neural structure and function in WS through adulthood. Typically developing children whom we will continue to study after they turn 18 will serve as the control comparison group for adults with Williams syndrome .
Primary outcome measures include size and integrity of grey and white matter; functional MRI BOLD responses during rest, cognitive and emotion information processing; DTI anisotropy measures of white matter tracts; tissue perfusion (blood flow) measured with arterial spin labeling (ASL); and mcDespot myelin water fraction.
Secondary outcome measures include relationship of neuropsychological assessments and genotyping to the imaging results.
Our prior success in delineating the brain phenotype in adult Williams syndrome patients will provide the crucial context within which to view the emergence and modification of these neural circuit abnormalities from a developmental perspective in children with Williams syndrome and from which to launch translational studies of specific gene effects on brain and behavioral phenotypes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Adults with WS or genetic abnormalities | – | –Adults with Williams syndrome or genetic abnormalities in chromosome 7q11.23 |
| Children with WS or genetic abnormalities | – | –children ages 5-17 with Williams Syndrome or genetic abnormalities in chromosome 7q11.23 |
| Parents | – | –Parents of children with 7q11.23 CNV will undergo blood draws |
| Unaffected Siblings | – | –Siblings of children with 7q11.23 CNV |
| Unrelated children | – | –Typically developing children ages ages 5-17 |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children with classic WS deletions, those with smaller deletions, and those with duplications of the WS region on chromosome band 7q11.23.
Key inclusion criteria (4 listed)
- Greater than 5 years old.
- Able to provide assent if below the age of 18, or consent if 18 years of age or older. Parents will provide consent for participants below the age of 18. For patients who do not have the capacity to provide informed consent, consent may be obtained from a guardian or the holder of the DPA.
- Additionally, 7q11.23 CNV participants must have a typical, 7q11.23 CNV or other genetic abnormality in the Williams syndrome critical region of chromosome 7q11.23, and control participants must have normal intelligence.
Key exclusion criteria (8 listed)
- For all participants who will participate in MRI scanning, the following exclusion criteria will apply:
- Any chronic or acute medical condition severe enough to interfere with task performance or interpretation of MRI data.
- Any medication that might interfere with task performance or interpretation of MRI data.
- Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye or other body part, dental braces).
- Pregnancy (a urine pregnancy test will be performed prior to all MRI procedures for all females of child-bearing potential.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
fMRI Task Procedures
Time frame: Ongoing
fMRI Task Procedures
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 29 Oct 2026.
- Background: PubMed 7666173Adolphs R, Tranel D, Damasio H, Damasio AR. Fear and the human amygdala. J Neurosci. 1995 Sep;15(9):5879-91. doi: 10.1523/JNEUROSCI.15-09-05879.1995.
- Background: PubMed 17761438Ashburner J. A fast diffeomorphic image registration algorithm. Neuroimage. 2007 Oct 15;38(1):95-113. doi: 10.1016/j.neuroimage.2007.07.007. Epub 2007 Jul 18.
- Background: PubMed 16168445Atkinson J, Braddick O, Rose FE, Searcy YM, Wattam-Bell J, Bellugi U. Dorsal-stream motion processing deficits persist into adulthood in Williams syndrome. Neuropsychologia. 2006;44(5):828-33. doi: 10.1016/j.neuropsychologia.2005.08.002. Epub 2005 Sep 15.
- Derived from this study: PubMed 37633900Kippenhan JS, Gregory MD, Nash T, Kohn P, Mervis CB, Eisenberg DP, Garvey MH, Roe K, Morris CA, Kolachana B, Pani AM, Sorcher L, Berman KF. Dorsal visual stream and LIMK1: hemideletion, haplotype, and enduring effects in children with Williams syndrome. J Neurodev Disord. 2023 Aug 26;15(1):29. doi: 10.1186/s11689-023-09493-x.
- Derived from this study: PubMed 33667672Chen G, Nash TA, Cole KM, Kohn PD, Wei SM, Gregory MD, Eisenberg DP, Cox RW, Berman KF, Shane Kippenhan J. Beyond linearity in neuroimaging: Capturing nonlinear relationships with application to longitudinal studies. Neuroimage. 2021 Jun;233:117891. doi: 10.1016/j.neuroimage.2021.117891. Epub 2021 Mar 3.
- Derived from this study: PubMed 29614955Gregory MD, Kolachana B, Yao Y, Nash T, Dickinson D, Eisenberg DP, Mervis CB, Berman KF. A method for determining haploid and triploid genotypes and their association with vascular phenotypes in Williams syndrome and 7q11.23 duplication syndrome. BMC Med Genet. 2018 Apr 4;19(1):53. doi: 10.1186/s12881-018-0563-3.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Karen F Berman, M.D. principal investigator
National Institute of Mental Health (NIMH)
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 Williams Syndrome and Duplication, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Tiffany A Nash ((240) 205-0333, tiffany.nash@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI Task Procedures (time frame: Ongoing). 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 NCT01132885, which also lists 6 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 29 Oct 2026.