Movement DisordersEarly Phase 1NCT00500994
Neurobiology of Functional Movement Disorder and Non-Epileptic Seizures
A Early Phase 1 study testing MRI in people with Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 2 sites in United States.
Trial summary
This study is part of a series of studies that will explore how the mind and the brain work to cause episodes of uncontrollable shaking in people who have no known underlying brain or medical disorder. The study is conducted at NIH and at the Brown University Rhode Island Hospital. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Movement Disorders
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2007to 13 Dec 2022
- Phase
- Early Phase 1
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria for FMD patients:
- Diagnosis of clinically definite FMD utilizing Fahn and Williams criteria. The diagnosis must be made by a neurologist
- Able to give informed consent
- Age 18 or older
- General Inclusion Criteria for Caregivers:
- Age 18 or older
Show all 15Show fewer
- Able to give informed consent
- Takes care of a patient with FMD patient enrolled in protocol 07-N-0190 for 10 or more weekly hours.
- General Inclusion Criteria for PNES patients:
- Diagnosis of PNES based on recording of patient s typical episode during 24 h video-EEG without concomitant EEG changes. The diagnosis must be made by a neurologist.
- Able to give informed consent
- Age 18 or older
- General Inclusion Criteria for Healthy Volunteers:
- Able to give informed consent
- Age 18 or older
Who cannot join
- General exclusion criteria for FMD patients:
- Significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy
- Inflammatory disorders or autoimmune disorders active within the last 6 months
- Patients with psychotic disorders or manic depression or active substance abuse within the last 6 months
- Current suicidal ideation
- Disease severity requiring inpatient treatment
Show all 36Show fewer
- Additional exclusion criteria for FMD patients for MRI:
- Patients with movement symptoms at rest that may substantially inhibit resolution, comfort, or safety of MRI
- Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations
- History of traumatic brain injury with loss of consciousness or amnesia lasting greater than a few seconds
- Contraindication to MRI
- Pregnancy
- Significant medical illness
- Patients with current post-traumatic stress disorder
- Patients on tricyclic antidepressants or antiepileptic medications 2 weeks prior to testing
- General exclusion criteria for PNES patients:
- Significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy
- Inflammatory disorders or autoimmune disorders active within the last 6 months
- Patients with psychotic disorders or active substance abuse within the last 6 months
- Current suicidal ideation
- Disease severity requiring inpatient treatment
- General exclusion criteria for healthy volunteers:
- Significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy
- History of DSM IV-defined schizophrenia, schizoaffective disorder, bipolar disorder or major depression with psychosis
- History of psychotic disorders or manic depression or active substance abuse within the last 6 months
- Subjects with post-traumatic stress disorder
- Subjects on antidepressants or antiepileptic medications
- Inflammatory disorders or autoimmune disorders active within the last 6 months
- Additional exclusion criteria for healthy volunteers for MRI:
- Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations
- Contraindication to MRI
- Pregnancy
- Significant medical illness
- General Exclusion Criteria for Caregivers:
- History of DSM-IV defined Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major depression with psychotic features (by interview).
- Active substance abuse within the past 6 months (by interview).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Rhode Island Hospital (RIH)
Providence, Rhode Island, 02903
About this study
Official title: Neurobiological Studies of Functional Movement Disorders and Non-Epileptic Seizures
This study is part of a series of studies that will explore how the mind and the brain work to cause episodes of uncontrollable shaking in people who have no known underlying brain or medical disorder. The study is conducted at NIH and at the Brown University Rhode Island Hospital.
Healthy volunteers and people with functional movement disorders (FMD) or non-epileptic seizures (NES) who are 18 years of age or older may be eligible for this study.
Read more
Patients with NES have 3 teaspoons of blood drawn. The blood is tested for two genes that are normally found in healthy individuals to see if they are found more frequently in patients with uncontrolled shaking.
Patients with FMD have blood drawn for testing and also undergo functional magnetic resonance imaging (fMRI) to look at how the brain functions while the subject performs a specific task. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the scan, the subject lies on a table that can slide in and out of the scanner, a metal cylinder. The scan lasts about 60 to 90 minutes, during which the subject may be asked to lie still for up to 10 minutes at a time and to perform tasks, such as identifying the gender of faces shown on a screen.
Healthy volunteers may have blood drawn for genetic testing or fMRI or both.
Read the detailed description
Objectives:
The study investigates the neurobiological correlates of conversion disorder (CD). The primary objectives are to investigate in CD patients:
- The role of emotional valence in an implicit emotional processing task (COMPLETE)
- The frequency of the 5HTTLPR S/S genotype
- Structural differences in grey matter of the brain as detected by voxel-based morphometry (VBM)
- The neural correlates of fear conditioning and fear extinction in a fear learning fMRI task
- The neural correlates of interoceptive activity in a Interoceptive Attention fMRI task
- Identifying the cortical physiology correlated with making a movement following a go command.
- Identifying the cortical physiology correlated with not making a movement following a no-go command.
- Identifying the cortical physiology correlated with planning to move or not move following a choose go-no go command.
Exploratory objectives are to investigate in CD patients:
- The frequency of several gene polymorphisms that are implicated in stress and affective disorder, including 5HTTLPR S/S (serotonin receptor), COMT (catechol-o-methyltransferase enzyme), Val/Met BDNF (brain-derived neurotrophic factor) and FKBP5 rs1360780 genotypes, as well as other polymorphisms or mutations to be determined later. Additionally, epigenetic data will be explored.
- The levels of salivary cortisol as a measure of stress.
- The heart rate variability, as a measure of autonomic nervous system function. (COMPLETE)
- Structural differences in white matter of the brain as detected by diffusion tensor imaging (DTI)
- The resting state BOLD fMRI signal
- The impact of the caregiver's attitude on the patients' symptoms
- The relationship between hemodynamic responses in regions implicated in interoception and self-reported measures of interoceptive attention, as well as behavioral and motor symptom severity
Study population:
We intend to study adult patients with diagnoses of functional movement disorders (FMD) seen by the Human Motor Control Section clinic (HMCS), patients with diagnoses of psychogenic non-epileptic seizures (PNES) seen by the Epilepsy clinic and healthy volunteers. Up to 12 healthy volunteers will be for the EEG-EMG sub-study. The PNES patient group will include patients seen at Rhode Island Hospital. Additionally, we would like to study caregivers of patient's with FMD who are enrolled un protocol 07-N-0190.
Design:
An assessment for psychiatric diagnoses and measurement scales will be administered to the FMD and PNES patients, healthy volunteer controls and caregivers.
- Functional MRI (fMRI): emotional processing will be studied using a gender identification task with differing emotional valences. (COMPLETE) Limbic processing will also be studied using a fear learning fMRI task. Resting state BOLD fMRI signal will also be obtained.
- Anatomical MRI: VBM and DTI will be performed using anatomical MRI sequences collected during the fMRI scanning or subsequent dedicated anatomical MRI sessions.
- Genetics: blood will be collected for testing.
- Stress biomarkers: saliva will be collected for testing. [EVALUATION IN HEALTHY VOLUNTEERS COMPLETE].
- Autonomic nervous system function: electrocardiogram (EKG) will be obtained to determine heart rate variability. [COMPLETE].
- Event related potentials: 64-channel EEG and surface EMG will be recorded during a go , no-go and choose go-no go behavioral task.
- EEG will be recorded during the resting state condition (five minutes with eyes open and five minutes with eyes closed).
Outcome measures:
- fMRI study: blood oxygenation level dependent (BOLD) signal in the regions of interest during a gender identification task (primary) [COMPLETE], in regions of interest during a fear learning task (primary), as well as resting state BOLD signal (exploratory). EEG resting state data will be compared and correlated with the fMRI resting state data.
- Anatomical MRI: VBM (primary) and DTI (exploratory)
- Genetics: (a) S/S genotype of the serotonin transporter promoter region polymorphism. (primary) (b) Polymorphism frequency of several genes related to affective disorders and/or stress (exploratory)
- Stress biomarkers: salivary cortisol levels (exploratory). [EVALUATION IN HEALTHY VOLUNTEERS COMPLETE]
- Autonomic nervous system function: heart rate variability as measured by EKG (exploratory). [COMPLETE]
- Psychological profile scales: scores exploratory.
- The relationship between hemodynamic responses in regions implicated in interoception and self-reported measures of IA, motor symptoms and behavioral ratings (exploratory)
- EEG-EMG study: Characteristics of event related cortical potentials correlated with simple behavioral motor tasks in healthy volunteers. Differences between go and no-go potentials will be identified and quantified. This analysis will allow planning a properly powered study for patients with functional movement disorders.
- Conditions
- Movement Disorders
- Being tested
- MRI
- Keywords
- Conversion Disorder, Psychogenic Movement Disorders, Non-Epileptic Seizure, Functional Magnetic Resonance Imaging (fMRI), Genetic Polymorphisms
- Medical subject headings
- Movement Disorders, Conversion Disorder, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
The imaging study will use a block design to (i) optimize amygdala activation to emotionally valenced images, (ii) to optimize analysis of PPI and (iii) to optimize the go/no-task design. G. T2-sensitive functional images will be obtained on a MRI system with a 1.5 Tesla superconducting magnet and a standard head coil. An echo planar image sequence (TR=2500msec, TE=33 msec, 90 flip angle) with 30 contiguous 2mm thick coronal oblique slices with 1 mm interslice gap centered over the amygdala, tilted 30 to the anterior, to improve susceptibility artifact. Three-dimensional anatomical images will be taken for the co-registration of the functional images.
| Study group | Role | What they receive |
|---|---|---|
| fMRI study | Experimental | subjects receiving MRI Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI study: blood oxygenation level dependent (BOLD) signal in the regions of interest during a gender identification task
fMRI BOLD signal change focusing on regions of interest during emotional valence task
Measured: throughout
Genetics: S/S genotype of the serotonin transporter promoter region polymorphism.
The S/S genotype of the 5HTTLPR polymorphism
Measured: throughout
Anatomical MRI: VBM
Structural grey matter brain data
Measured: throughout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study start5 Oct 2007
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
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 Movement DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hyun Joo Cho, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500994
- Sponsor's protocol ID
- 070190
- Other IDs
- 07-N-0190
- Status last verified
- May 2025
- First submitted
- 12 Jul 2007
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Waugh RE, Parker JA, Hallett M, Horovitz SG. Classification of Functional Movement Disorders with Resting-State Functional Magnetic Resonance Imaging. Brain Connect. 2023 Feb;13(1):4-14. doi: 10.1089/brain.2022.0001. Epub 2022 Jun 16.
PubMed 35570651
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobiological Studies of Functional Movement Disorders and Non-Epileptic Seizures
- ClinicalTrials.gov ID
- NCT00500994
- Acronym / sponsor ID
- 070190
- Conditions
- Movement Disorders
- Keywords
- Conversion Disorder, Psychogenic Movement Disorders, Non-Epileptic Seizure, Functional Magnetic Resonance Imaging (fMRI), Genetic Polymorphisms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 5 Oct 2007 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 13 Jul 2007 (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.
This study is part of a series of studies that will explore how the mind and the brain work to cause episodes of uncontrollable shaking in people who have no known underlying brain or medical disorder. The study is conducted at NIH and at the Brown University Rhode Island Hospital.
Healthy volunteers and people with functional movement disorders (FMD) or non-epileptic seizures (NES) who are 18 years of age or older may be eligible for this study.
Patients with NES have 3 teaspoons of blood drawn. The blood is tested for two genes that are normally found in healthy individuals to see if they are found more frequently in patients with uncontrolled shaking.
Patients with FMD have blood drawn for testing and also undergo functional magnetic resonance imaging (fMRI) to look at how the brain functions while the subject performs a specific task. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the scan, the subject lies on a table that can slide in and out of the scanner, a metal cylinder. The scan lasts about 60 to 90 minutes, during which the subject may be asked to lie still for up to 10 minutes at a time and to perform tasks, such as identifying the gender of faces shown on a screen.
Healthy volunteers may have blood drawn for genetic testing or fMRI or both.
Detailed description
Objectives:
The study investigates the neurobiological correlates of conversion disorder (CD). The primary objectives are to investigate in CD patients:
- The role of emotional valence in an implicit emotional processing task (COMPLETE)
- The frequency of the 5HTTLPR S/S genotype
- Structural differences in grey matter of the brain as detected by voxel-based morphometry (VBM)
- The neural correlates of fear conditioning and fear extinction in a fear learning fMRI task
- The neural correlates of interoceptive activity in a Interoceptive Attention fMRI task
- Identifying the cortical physiology correlated with making a movement following a go command.
- Identifying the cortical physiology correlated with not making a movement following a no-go command.
- Identifying the cortical physiology correlated with planning to move or not move following a choose go-no go command.
Exploratory objectives are to investigate in CD patients:
- The frequency of several gene polymorphisms that are implicated in stress and affective disorder, including 5HTTLPR S/S (serotonin receptor), COMT (catechol-o-methyltransferase enzyme), Val/Met BDNF (brain-derived neurotrophic factor) and FKBP5 rs1360780 genotypes, as well as other polymorphisms or mutations to be determined later. Additionally, epigenetic data will be explored.
- The levels of salivary cortisol as a measure of stress.
- The heart rate variability, as a measure of autonomic nervous system function. (COMPLETE)
- Structural differences in white matter of the brain as detected by diffusion tensor imaging (DTI)
- The resting state BOLD fMRI signal
- The impact of the caregiver's attitude on the patients' symptoms
- The relationship between hemodynamic responses in regions implicated in interoception and self-reported measures of interoceptive attention, as well as behavioral and motor symptom severity
Study population:
We intend to study adult patients with diagnoses of functional movement disorders (FMD) seen by the Human Motor Control Section clinic (HMCS), patients with diagnoses of psychogenic non-epileptic seizures (PNES) seen by the Epilepsy clinic and healthy volunteers. Up to 12 healthy volunteers will be for the EEG-EMG sub-study. The PNES patient group will include patients seen at Rhode Island Hospital. Additionally, we would like to study caregivers of patient's with FMD who are enrolled un protocol 07-N-0190.
Design:
An assessment for psychiatric diagnoses and measurement scales will be administered to the FMD and PNES patients, healthy volunteer controls and caregivers.
- Functional MRI (fMRI): emotional processing will be studied using a gender identification task with differing emotional valences. (COMPLETE) Limbic processing will also be studied using a fear learning fMRI task. Resting state BOLD fMRI signal will also be obtained.
- Anatomical MRI: VBM and DTI will be performed using anatomical MRI sequences collected during the fMRI scanning or subsequent dedicated anatomical MRI sessions.
- Genetics: blood will be collected for testing.
- Stress biomarkers: saliva will be collected for testing. [EVALUATION IN HEALTHY VOLUNTEERS COMPLETE].
- Autonomic nervous system function: electrocardiogram (EKG) will be obtained to determine heart rate variability. [COMPLETE].
- Event related potentials: 64-channel EEG and surface EMG will be recorded during a go , no-go and choose go-no go behavioral task.
- EEG will be recorded during the resting state condition (five minutes with eyes open and five minutes with eyes closed).
Outcome measures:
- fMRI study: blood oxygenation level dependent (BOLD) signal in the regions of interest during a gender identification task (primary) [COMPLETE], in regions of interest during a fear learning task (primary), as well as resting state BOLD signal (exploratory). EEG resting state data will be compared and correlated with the fMRI resting state data.
- Anatomical MRI: VBM (primary) and DTI (exploratory)
- Genetics: (a) S/S genotype of the serotonin transporter promoter region polymorphism. (primary) (b) Polymorphism frequency of several genes related to affective disorders and/or stress (exploratory)
- Stress biomarkers: salivary cortisol levels (exploratory). [EVALUATION IN HEALTHY VOLUNTEERS COMPLETE]
- Autonomic nervous system function: heart rate variability as measured by EKG (exploratory). [COMPLETE]
- Psychological profile scales: scores exploratory.
- The relationship between hemodynamic responses in regions implicated in interoception and self-reported measures of IA, motor symptoms and behavioral ratings (exploratory)
- EEG-EMG study: Characteristics of event related cortical potentials correlated with simple behavioral motor tasks in healthy volunteers. Differences between go and no-go potentials will be identified and quantified. This analysis will allow planning a properly powered study for patients with functional movement disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fMRI study | Experimental | Device: MRIsubjects receiving MRI |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of clinically definite FMD utilizing Fahn and Williams criteria. The diagnosis must be made by a neurologist
- Able to give informed consent
- Age 18 or older
- Age 18 or older
- Able to give informed consent
Key exclusion criteria (36 listed)
- Significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy
- Inflammatory disorders or autoimmune disorders active within the last 6 months
- Patients with psychotic disorders or manic depression or active substance abuse within the last 6 months
- Current suicidal ideation
- Disease severity requiring inpatient treatment
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 |
|---|---|---|
| MRIThe imaging study will use a block design to (i) optimize amygdala activation to emotionally valenced images, (ii) to optimize analysis of PPI and (iii) to optimize the go/no-task design. G. T2-sensitive functional images will be obtained on a MRI system with a 1.5 Tesla superconducting magnet and a standard head coil. An echo planar image sequence (TR=2500msec, TE=33 msec, 90 flip angle) with 30 contiguous 2mm thick coronal oblique slices with 1 mm interslice gap centered over the amygdala, tilted 30 to the anterior, to improve susceptibility artifact. Three-dimensional anatomical images will be taken for the co-registration of the functional images. | Device | fMRI study |
Primary outcome
fMRI study: blood oxygenation level dependent (BOLD) signal in the regions of interest during a gender identification task
Time frame: throughout
fMRI BOLD signal change focusing on regions of interest during emotional valence task
Genetics: S/S genotype of the serotonin transporter promoter region polymorphism.
Time frame: throughout
The S/S genotype of the 5HTTLPR polymorphism
Anatomical MRI: VBM
Time frame: throughout
Structural grey matter brain data
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 16 May 2025.
- Derived from this study: PubMed 35570651Waugh RE, Parker JA, Hallett M, Horovitz SG. Classification of Functional Movement Disorders with Resting-State Functional Magnetic Resonance Imaging. Brain Connect. 2023 Feb;13(1):4-14. doi: 10.1089/brain.2022.0001. Epub 2022 Jun 16.
- 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. This study is not recruiting at the moment.
Hyun Joo Cho, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MRI in people with Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 2 sites 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 15 inclusion and 36 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 16 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
fMRI study: blood oxygenation level dependent (BOLD) signal in the regions of interest during a gender identification task (time frame: throughout). The study lists 3 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 NCT00500994, 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 16 May 2025.