Multiple SclerosisEarly Phase 1NCT04634994
Assessment of Synaptic Density in MS
A Early Phase 1 study testing [F-18]SDM-8 in people with Multiple Sclerosis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The investigators propose to use the novel SV2a-PET ligand, [F-18]SDM-8 to assess synaptic density in progressive multiple sclerosis (PMS) (including primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS)), given its improved imaging characteristics and potential for large… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- [F-18]SDM-8
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to 31 Dec 2026
- Phase
- Early Phase 1
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects meeting the definition for MS (including PPMS, RRMS or SPMS) by International Panel (2017 McDonald) Criteria. Age and sex-matched healthy controls will also be recruited.
- Subjects willing to undergo PET and MRI imaging
- Subjects willing and able to give informed consent
Who cannot join
- Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
- Individuals with bipolar disease and schizophrenia
- Concurrent medical conditions that contraindicate study procedures.
- Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.
- Claustrophobia
- Non-MRI compatible implanted devices
- Corticosteroid treatment in the past four weeks
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
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Steven Cicero, 617-264-3044, scicero@bwh.harvard.edu
Tarun Singhal, MD
About this study
Official title: Novel Assessment of Synaptic Density in Progressive MS
The investigators propose to use the novel SV2a-PET ligand, [F-18]SDM-8 to assess synaptic density in progressive multiple sclerosis (PMS) (including primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS)), given its improved imaging characteristics and potential for large scale applicability.
The specific aims of the study are:
Read more
Aim 1: To compare the cortical and subcortical grey matter synaptic density in PMS patients, patients with relapsing-remitting MS (RRMS), and healthy subjects, using a novel [F-18] labeled synaptic density PET ligand, [F-18]SDM8, also known as [F-18]SynvesT-1.
Aim 2: To compare the relationship of synaptic density PET and standard 3T MRI measures including global and regional brain atrophy and lesion load with clinical measures of physical disability, cognitive impairment, fatigue and depression in MS patients.
Aim 3: To assess the relationship of synaptic density PET with serum neurofilament light chain (NfL) and with serum measurements of inflammatory markers, IL-1β, TNF-α, IL-6, MCP-1 (Monocyte Chemoattractant Protein-1) and MIF-1 (Macrophage Migration Inhibitory Factor-1).
Read the detailed description
This is a single center, cross-sectional study of synaptic density measurement in patients with progressive MS as compared to RRMS and healthy controls.
Three groups of subjects will be recruited:
- Subjects meeting the definition for PMS (PPMS or SPMS) by International Panel Criteria
- Subjects meeting the definition for RRMS by the International Panel Criteria,
- Healthy Controls
Sample Size: We plan to enroll 40 subjects including at least 10 with PMS (PPMS or SPMS), 10 with RRMS and 10 healthy controls. This is a pilot study and the sample size estimations are not based on power calculations. In order to attain our goal sample size of 30 subjects, we estimate that we may need to enroll approximately 40 subjects to account for screen failures.
Physicians at the Brigham MS Center may present the study to a subject during a regular scheduled clinic visit. If the subject is interested in the study, a copy of the consent form will be given. The subject will then be contacted by telephone prior to the screening visit appointment. At the time of the subject's screening visit, an investigator will go over the study in detail, answer any questions the subject may have regarding the study and a licensed physician investigator will obtain informed consent. In accordance with NIH guidelines, efforts will be made to attain a mix of study participants, in terms of gender and racial/ethnic representation.
Subjects may be required to come for up to 4 visits for this study.
Initial Visit:
During the first visit, subjects will be administered the screening questionnaire (if that has not already been done over telephone). Subjects will review and sign the consent form. They will be administered standardized questionnaires for cognitive testing and/or other co-morbidities.
PET Visit:
All subjects will undergo one visit for the PET scan. During the PET scan visits, all women subjects of child bearing age will undergo a stat quantitative serum hCG pregnancy test (or urine pregnancy test) and only women with a negative test will undergo the radiopharmaceutical injection.
PET imaging procedures
For PET scanning, an intravenous (IV) catheter will be inserted into the radial antecubital or other arm or hand vein for injection of tracer. Radiopharmaceutical will be injected as a bolus (approximately 5mCi for [F-18]SynVest-1 followed by 5 mL of saline).
The whole PET session will last up to 120 min.
MRI Visit:
All subjects will undergo a 3T Brain MRI during an MRI visit that may precede or follow the PET scan visit.
Pregnancy screening prior to MRI:
All women will be queried about their pregnancy status, use of contraception and last menstrual period. If they are reliably using contraception, can state the timing of their last menstrual period, and do not believe they could be pregnant, we will proceed with the MRI scan without pregnancy testing. If they cannot do this, then they will undergo a urine pregnancy test. If a woman is seeking pregnancy and not using contraception, she will undergo a urine pregnancy test.
MRI imaging procedures MRI scanning session will be performed at BWH MRI facility at 60 Fenwood Road, Boston, MA.
Several pulse sequences will be performed to image the brain. There will be no intravenous contrast used for any of the MRIs.
The MRI scan session will take approximately 1 hour.
A non-diagnostic CT scan will be performed for attenuation correction of PET transmission data at the time of initiation of scanning.
For the PET portion, as this drug is radioactive, the subject will be exposed to a small amount of radiation as a result of participation in this study. The per unit radiation dose for [F-18]SynVEst-1 is 1.4mSv/mCi_(37.8 μSv/MBq). The total amount of radiation exposure from [F-18]SynVEst-1 is 7mSv (for 5mCi injected dose). This amount of radiation is approximately 14% of the yearly amount of radiation allowed for persons who work with radiation. Additional dose from low dose CT performed for attenuation correction of PET images is estimated to be 1mSv per CT scan. Hence, the total radiation exposure from the procedure is 8mSv or approximately 16% of the yearly amount of radiation exposure allowed for persons working with radiation.
- Conditions
- Multiple Sclerosis
- Being tested
- [F-18]SDM-8
- Keywords
- Multiple Sclerosis, MS, Synaptic Density, Positron Emission Tomography, PET
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]SDM-8Drug
PET radiopharmaceutical. Subjects will undergo [F-18]SDM-8 PET Scanning to measure synaptic density.
| Study group | Role | What they receive |
|---|---|---|
| PMS, RRMS, and Healthy Control Subjects | Experimental | Not described Receives: Drug: [F-18]SDM-8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET measurements in individuals with PMS, RRMS, and healthy controls
To compare PET measurements including standardized uptake value (SUV) and standardized uptake value ratio (SUVR) in individuals with PMS, RRMS, and healthy controls.
Measured: Baseline
Secondary outcomes (1)
Correlations between PET measurements and clinical, MRI, and blood and serum measures
To examine correlations between PET measurements and clinical measures (e.g., Expanded Disability Status Scale, Timed 25 Foot Walk, Symbol Digit Modalities Test), MRI measures (e.g., global atrophy, regional atrophy, lesion load), and blood and serum biomarkers (e.g., nNfL).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start14 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, TARUN SINGHAL, Brigham and Women's Hospital
- Investigators
- Tarun Singhal, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634994
- Sponsor's protocol ID
- 2020P003171
- Status last verified
- Jan 2026
- First submitted
- 9 Nov 2020
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tourdias T, Dousset V. Neuroinflammatory imaging biomarkers: relevance to multiple sclerosis and its therapy. Neurotherapeutics. 2013 Jan;10(1):111-23. doi: 10.1007/s13311-012-0155-4.
PubMed 23132327Mendoza-Torreblanca JG, Vanoye-Carlo A, Phillips-Farfan BV, Carmona-Aparicio L, Gomez-Lira G. Synaptic vesicle protein 2A: basic facts and role in synaptic function. Eur J Neurosci. 2013 Dec;38(11):3529-39. doi: 10.1111/ejn.12360. Epub 2013 Sep 16.
PubMed 24102679Cai Z, Li S, Matuskey D, Nabulsi N, Huang Y. PET imaging of synaptic density: A new tool for investigation of neuropsychiatric diseases. Neurosci Lett. 2019 Jan 19;691:44-50. doi: 10.1016/j.neulet.2018.07.038. Epub 2018 Jul 31.
PubMed 30075287Wegner C, Esiri MM, Chance SA, Palace J, Matthews PM. Neocortical neuronal, synaptic, and glial loss in multiple sclerosis. Neurology. 2006 Sep 26;67(6):960-7. doi: 10.1212/01.wnl.0000237551.26858.39.
PubMed 17000961Mandolesi G, Grasselli G, Musumeci G, Centonze D. Cognitive deficits in experimental autoimmune encephalomyelitis: neuroinflammation and synaptic degeneration. Neurol Sci. 2010 Nov;31(Suppl 2):S255-9. doi: 10.1007/s10072-010-0369-3.
PubMed 20635112Di Filippo M, Portaccio E, Mancini A, Calabresi P. Multiple sclerosis and cognition: synaptic failure and network dysfunction. Nat Rev Neurosci. 2018 Oct;19(10):599-609. doi: 10.1038/s41583-018-0053-9.
PubMed 30158590Friese MA. Widespread synaptic loss in multiple sclerosis. Brain. 2016 Jan;139(Pt 1):2-4. doi: 10.1093/brain/awv349. No abstract available.
PubMed 26747852Peterson JW, Bo L, Mork S, Chang A, Trapp BD. Transected neurites, apoptotic neurons, and reduced inflammation in cortical multiple sclerosis lesions. Ann Neurol. 2001 Sep;50(3):389-400. doi: 10.1002/ana.1123.
PubMed 11558796Weiner HL. The challenge of multiple sclerosis: how do we cure a chronic heterogeneous disease? Ann Neurol. 2009 Mar;65(3):239-48. doi: 10.1002/ana.21640.
PubMed 19334069
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Assessment of Synaptic Density in Progressive MS
- ClinicalTrials.gov ID
- NCT04634994
- Acronym / sponsor ID
- 2020P003171
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, Synaptic Density, Positron Emission Tomography, PET
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 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.
The investigators propose to use the novel SV2a-PET ligand, [F-18]SDM-8 to assess synaptic density in progressive multiple sclerosis (PMS) (including primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS)), given its improved imaging characteristics and potential for large scale applicability.
The specific aims of the study are:
Aim 1: To compare the cortical and subcortical grey matter synaptic density in PMS patients, patients with relapsing-remitting MS (RRMS), and healthy subjects, using a novel [F-18] labeled synaptic density PET ligand, [F-18]SDM8, also known as [F-18]SynvesT-1.
Aim 2: To compare the relationship of synaptic density PET and standard 3T MRI measures including global and regional brain atrophy and lesion load with clinical measures of physical disability, cognitive impairment, fatigue and depression in MS patients.
Aim 3: To assess the relationship of synaptic density PET with serum neurofilament light chain (NfL) and with serum measurements of inflammatory markers, IL-1β, TNF-α, IL-6, MCP-1 (Monocyte Chemoattractant Protein-1) and MIF-1 (Macrophage Migration Inhibitory Factor-1).
Detailed description
This is a single center, cross-sectional study of synaptic density measurement in patients with progressive MS as compared to RRMS and healthy controls.
Three groups of subjects will be recruited:
- Subjects meeting the definition for PMS (PPMS or SPMS) by International Panel Criteria
- Subjects meeting the definition for RRMS by the International Panel Criteria,
- Healthy Controls
Sample Size: We plan to enroll 40 subjects including at least 10 with PMS (PPMS or SPMS), 10 with RRMS and 10 healthy controls. This is a pilot study and the sample size estimations are not based on power calculations. In order to attain our goal sample size of 30 subjects, we estimate that we may need to enroll approximately 40 subjects to account for screen failures.
Physicians at the Brigham MS Center may present the study to a subject during a regular scheduled clinic visit. If the subject is interested in the study, a copy of the consent form will be given. The subject will then be contacted by telephone prior to the screening visit appointment. At the time of the subject's screening visit, an investigator will go over the study in detail, answer any questions the subject may have regarding the study and a licensed physician investigator will obtain informed consent. In accordance with NIH guidelines, efforts will be made to attain a mix of study participants, in terms of gender and racial/ethnic representation.
Subjects may be required to come for up to 4 visits for this study.
Initial Visit:
During the first visit, subjects will be administered the screening questionnaire (if that has not already been done over telephone). Subjects will review and sign the consent form. They will be administered standardized questionnaires for cognitive testing and/or other co-morbidities.
PET Visit:
All subjects will undergo one visit for the PET scan. During the PET scan visits, all women subjects of child bearing age will undergo a stat quantitative serum hCG pregnancy test (or urine pregnancy test) and only women with a negative test will undergo the radiopharmaceutical injection.
PET imaging procedures
For PET scanning, an intravenous (IV) catheter will be inserted into the radial antecubital or other arm or hand vein for injection of tracer. Radiopharmaceutical will be injected as a bolus (approximately 5mCi for [F-18]SynVest-1 followed by 5 mL of saline).
The whole PET session will last up to 120 min.
MRI Visit:
All subjects will undergo a 3T Brain MRI during an MRI visit that may precede or follow the PET scan visit.
Pregnancy screening prior to MRI:
All women will be queried about their pregnancy status, use of contraception and last menstrual period. If they are reliably using contraception, can state the timing of their last menstrual period, and do not believe they could be pregnant, we will proceed with the MRI scan without pregnancy testing. If they cannot do this, then they will undergo a urine pregnancy test. If a woman is seeking pregnancy and not using contraception, she will undergo a urine pregnancy test.
MRI imaging procedures MRI scanning session will be performed at BWH MRI facility at 60 Fenwood Road, Boston, MA.
Several pulse sequences will be performed to image the brain. There will be no intravenous contrast used for any of the MRIs.
The MRI scan session will take approximately 1 hour.
A non-diagnostic CT scan will be performed for attenuation correction of PET transmission data at the time of initiation of scanning.
For the PET portion, as this drug is radioactive, the subject will be exposed to a small amount of radiation as a result of participation in this study. The per unit radiation dose for [F-18]SynVEst-1 is 1.4mSv/mCi_(37.8 μSv/MBq). The total amount of radiation exposure from [F-18]SynVEst-1 is 7mSv (for 5mCi injected dose). This amount of radiation is approximately 14% of the yearly amount of radiation allowed for persons who work with radiation. Additional dose from low dose CT performed for attenuation correction of PET images is estimated to be 1mSv per CT scan. Hence, the total radiation exposure from the procedure is 8mSv or approximately 16% of the yearly amount of radiation exposure allowed for persons working with radiation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PMS, RRMS, and Healthy Control Subjects | Experimental | Drug: [F-18]SDM-8 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects meeting the definition for MS (including PPMS, RRMS or SPMS) by International Panel (2017 McDonald) Criteria. Age and sex-matched healthy controls will also be recruited.
- Subjects willing to undergo PET and MRI imaging
- Subjects willing and able to give informed consent
Key exclusion criteria (7 listed)
- Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
- Individuals with bipolar disease and schizophrenia
- Concurrent medical conditions that contraindicate study procedures.
- Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.
- Claustrophobia
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 |
|---|---|---|
| [F-18]SDM-8PET radiopharmaceutical. Subjects will undergo [F-18]SDM-8 PET Scanning to measure synaptic density. | Drug | PMS, RRMS, and Healthy Control Subjects |
Primary outcome
PET measurements in individuals with PMS, RRMS, and healthy controls
Time frame: Baseline
To compare PET measurements including standardized uptake value (SUV) and standardized uptake value ratio (SUVR) in individuals with PMS, RRMS, and healthy controls.
1 secondary outcome
Correlations between PET measurements and clinical, MRI, and blood and serum measures
Time frame: Baseline
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 9 Jan 2026.
- Background: PubMed 23132327Tourdias T, Dousset V. Neuroinflammatory imaging biomarkers: relevance to multiple sclerosis and its therapy. Neurotherapeutics. 2013 Jan;10(1):111-23. doi: 10.1007/s13311-012-0155-4.
- Background: PubMed 24102679Mendoza-Torreblanca JG, Vanoye-Carlo A, Phillips-Farfan BV, Carmona-Aparicio L, Gomez-Lira G. Synaptic vesicle protein 2A: basic facts and role in synaptic function. Eur J Neurosci. 2013 Dec;38(11):3529-39. doi: 10.1111/ejn.12360. Epub 2013 Sep 16.
- Background: PubMed 30075287Cai Z, Li S, Matuskey D, Nabulsi N, Huang Y. PET imaging of synaptic density: A new tool for investigation of neuropsychiatric diseases. Neurosci Lett. 2019 Jan 19;691:44-50. doi: 10.1016/j.neulet.2018.07.038. Epub 2018 Jul 31.
- Background: PubMed 17000961Wegner C, Esiri MM, Chance SA, Palace J, Matthews PM. Neocortical neuronal, synaptic, and glial loss in multiple sclerosis. Neurology. 2006 Sep 26;67(6):960-7. doi: 10.1212/01.wnl.0000237551.26858.39.
- Background: PubMed 20635112Mandolesi G, Grasselli G, Musumeci G, Centonze D. Cognitive deficits in experimental autoimmune encephalomyelitis: neuroinflammation and synaptic degeneration. Neurol Sci. 2010 Nov;31(Suppl 2):S255-9. doi: 10.1007/s10072-010-0369-3.
- Background: PubMed 30158590Di Filippo M, Portaccio E, Mancini A, Calabresi P. Multiple sclerosis and cognition: synaptic failure and network dysfunction. Nat Rev Neurosci. 2018 Oct;19(10):599-609. doi: 10.1038/s41583-018-0053-9.
- Background: PubMed 26747852Friese MA. Widespread synaptic loss in multiple sclerosis. Brain. 2016 Jan;139(Pt 1):2-4. doi: 10.1093/brain/awv349. No abstract available.
- Background: PubMed 11558796Peterson JW, Bo L, Mork S, Chang A, Trapp BD. Transected neurites, apoptotic neurons, and reduced inflammation in cortical multiple sclerosis lesions. Ann Neurol. 2001 Sep;50(3):389-400. doi: 10.1002/ana.1123.
- Background: PubMed 19334069Weiner HL. The challenge of multiple sclerosis: how do we cure a chronic heterogeneous disease? Ann Neurol. 2009 Mar;65(3):239-48. doi: 10.1002/ana.21640.
- 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.
Tarun Singhal, MD principal investigator
Brigham and Women's Hospital
1 site 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 [F-18]SDM-8 in people with Multiple Sclerosis, run by Brigham and Women's Hospital 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 3 inclusion and 7 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 9 Jan 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.
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?
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 Tarun Singhal, MD (617-264-3043, tsinghal@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET measurements in individuals with PMS, RRMS, and healthy controls (time frame: Baseline). 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 NCT04634994, which also lists 9 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 9 Jan 2026.