Smokingnic_physoNCT02008292
Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors
A study testing Physostigmine in people with Smoking and Schizophrenia, run by Yale University at 3 sites in United States.
Trial summary
The purpose of the study is to measure the sensitivity of NCFHEB binding to changes in endogenous acetylcholine levels in healthy smoking and nonsmoking subjects, and in schizophrenic smoking and nonsmoking subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Schizophrenia
- What is being tested?
- Physostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2013to Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- who are able to read and write
- who are able to give voluntary written informed consent
- have no current uncontrolled medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology
- have no history of a neurological or psychiatric disorder (DSMIV Axis 1 and 2) other than schizophrenia in schizophrenia subgroup
- have not regularly used any prescription, herbal or illegal psychotropic medications (e.g. antidepressants, antipsychotics, anxiolytics, ecstasy) in the past 6 months (controls).
- Subjects with schizophrenia have not used any herbal or illegal substances in the past 6 months (medication inclusion listed below in Aim 5)
Show all 13Show fewer
- drink less than <21 drinks/week for women and less than <35 drinks per week for men
- have not used marijuana in the past 30 days and have not met criteria for dependence in the past 2 years
- If female, not pregnant or breast feeding
- If female of childbearing age, must use an acceptable method of birth control, as determined by the principal investigator
- do not suffer from claustrophobia or any MR contradictions
- willing to donate blood for genetic studies
- willing to be followed up monthly after study participation via phone or email contact
Who cannot join
- Presence of acute or unstable medical or neurological illness. Subjects will be excluded from the study if they present with any history of serious medical or neurological illness or if they show signs of a major medical or neurological illness on examination or lab testing including history of seizures, head injury, brain tumor, heart, liver or kidney disease, eating disorder, diabetes.
- Presence of an Axis I diagnosis other than nicotine dependence and schizophrenia (for schizophrenia subgroup) in the past 2 years
- Regular use of any psychotropic drugs including anxiolytics and antidepressants and other over-the-counter medications and herbal products within the last year, and none within the last month for healthy controls.
- Regular use of antidepressants or psychotropic over-the-counter medications and herbal products within the last year
- For subjects with Schizophrenia, use of SSRI's (Paxil, Prozac Zoloft, Lexapro and Celexa) and use of tricyclic anti-depressants, except for a minimal dose used to treat anything other than depression, per the Investigator's discretion.
- Pregnancy/Breast feeding
Show all 14Show fewer
- Subjects with a pacemaker or other ferromagnetic material in body.
- Subjects with a sitting pulse rate >100 bpm will be excluded
- Subjects with hypertension defined as sitting systolic blood pressure of >160 mmHg and/or sitting diastolic blood pressure of >100 mmHg will be excluded. Those individuals with hypertension that is well controlled by medication (e.g., within the above mentioned range) are not excluded
- Specifically, we will exclude subjects who have any active clinically significant deviation from the normal range in their electrocardiogram (EKG). However, subjects who have abnormalities in their EKG but the condition has been present for a while and the study cardiologist has evaluated and feels comfortable with the condition, would not be excluded on the basis of their cardiac condition. Examples of conditions that may meet these criteria (e.g., condition has been present for a while) include but are not limited to T-wave abnormalities, atrial fibrillation, prolonged PR interval, and right bundle branch block.
- Subjects with an allergy to salicylates
- Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
- Subjects with current, past or anticipated exposure to radiation in the work place
- Blood donation within eight weeks of the start of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Connecticut Mental Health Center
New Haven, Connecticut, 06519
Yale Magnetic Resonance Research Center
New Haven, Connecticut, 06519
Yale PET Center
New Haven, Connecticut, 06519
About this study
The purpose of the study is to measure the sensitivity of NCFHEB binding to changes in endogenous acetylcholine levels in healthy smoking and nonsmoking subjects, and in schizophrenic smoking and nonsmoking subjects. We hypothesize that physostigmine-induced elevated ACh levels will lead to a reduction in the availability of nicotinic receptors for the binding of the radioligand. We hypothesize there will be greater increase in ACh level (or greater reduction in radio tracer binding) in smoking as compared to nonsmoking subjects. We hypothesize there will be greater increase in ACh level (or greater reduction in radio tracer binding) in smoking as compared to nonsmoking subjects with schizophrenia, but the extent of this change will be different than in controls.
We are also measuring the sensitivity of PHNO binding to changes in dopamine levels in healthy smoking and nonsmoking subjects before and after amphetamine challenge.
Read the detailed description
- Magnetic resonance image. Within approximately two weeks of the PET study, anatomical MRIs will be acquired at the Yale University MRI Center. Subjects will be taken through a ferromagnetic metal detector before entering the scan room. The purpose of the MRI scan is to direct the region of interest placement on the lower resolution PET images. The T1 weighted images will be acquired on a 3 Tesla Siemens Scanner. There will also be an additional resting state scan with subjects in the scanner, eyes open, fixating on a cross.
- Physostigmine challenge Physostigmine will be administered as follows. Glycopyrrolate, a cholinergic antagonist that does not have central side-effects, will be administered prior to physostigmine challenge to block physostigmine peripheral side-effects (e.g. nausea). Subjects will receive 200 mcg /ml x 1 ml of glycopyrrolate through an IV. Physostigmine administered i.v. has a short half life of 20 min with peak plasma levels 20-30 min post administration. The same dose of physostigmine will be administered as in the preliminary data: 1.5 mg/hr for 1 hr. Vital signs, including systolic and diastolic blood pressure, heart rate and respiration rate, will be monitored before physostigmine and then at 10, 20, 30, 60 min after the beginning of the infusion and then hourly until the end of the study day. Subjects will be questioned before, during, and after physostigmine challenge about potential adverse reactions typical to this medication (nausea, upset stomach, etc., as in Risks section). [If there is a significant and persistent drop in subjects' heart rate (>15% for at least 1 min), the IV physostigmine infusion will be stopped but the subject will continue to be monitored and will be discharged at the discretion of the study doctor. In emergency situation, PET center protocol will be followed accordingly (on file with HIC).
- Amphetamine challenge On PHNO PET days, subjects will have a baseline PHNO scan and then will receive amphetamine by mouth (0.5mg/kg). Approximately 2.5 hours after amphetamine administration, subjects will be scanned with PHNO again.
- Positron emission tomography PET scans may be performed on the High Resolution Research Tomograph (HRRT, 2-3 mm resolution) or another similar camera. Venous catheters will be used for i.v. administration of the radiotracer, venous blood sampling of AChE activity, and for the administration of glycopyrrolate and physostigmine. A radial artery catheter will be inserted by an experienced physician before the PET scan to draw arterial blood samples for metabolite analysis and for determination of the fraction of plasma radioactivity unbound to protein. At the beginning of scan, the subject's head will be immobilized and a transmission scan will be obtained for attenuation correction. PET scans will be acquired using bolus or bolus to infusion administration of up to 10 millicuries of NCFHEB or PHNO. Dynamic images of radioactivity concentration are reconstructed with corrections for attenuation, normalization, random events, scatter, and deadtime. Subject motion is corrected automatically on an event-by-event basis with the Vicra motion tracking system. Vital signs (blood pressure, pulse and respiration) are collected prior to and during each PET scan. Urine pregnancy test will be again administered on the PET scan day prior to the initiation of any imaging procedures. Smoking abstinence, when appropriate, will also be confirmed for smoking subjects prior to PET scanning.
PET scanning will then proceed as following for each aim:
Aim 1. Subjects will be asked to come to the PET center on two separate days to participate in one NCFHEB PET scan each time to assess test retest reproducibility of binding parameters measured with the radiotracer.
Aim 2. Subjects will participate in one PET scan day. Aim 3. Subjects from Aim 2 who are able to continue smoking abstinence will be asked to come back for another PET scan after about 6-8 weeks of smoking abstinence.
Aim 4. Baseline NCFHEB PET imaging will be conducted followed by administration of physostigmine. Preferably, this will be done on the same day. However, at times there is not enough radiotracer or subject is not able to tolerate a longer scan day. Therefore, some subjects may complete the study over two separate days (preferably within 1 month apart based on the availability of PET scanning times and subject's schedule).
Aim 5. Baseline NCFHEB PET imaging will be conducted followed by administration of physostigmine. Preferably, this will be done on the same day. However, at times when there is not enough radiotracer or when a subject is not able to tolerate a longer scan day. Therefore, some subjects may complete the study over two separate days (preferably within 1 month apart based on the availability of PET scanning times and subject's schedule).
Control subjects may participate in more than 1 aim. For example, nonsmoking subjects may complete Aim 1 and if chose, participate in Aim 4. Thus, subjects may participate in up to 4 PET scans for this protocol.
Aim 7. Subjects from Aim 4 will be asked to participate in 2 PHNO PET scans and amphetamine administration.
- Conditions
- Smoking, Schizophrenia
- Being tested
- Physostigmine
- Keywords
- smoking, schizophrenia, acetylcholine
- Medical subject headings
- Smoking, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysostigmineDrug
Also called IV physostigmine
All subjects will receive physostigmine to induce elevated ACh levels in the brain.
| Study group | Role | What they receive |
|---|---|---|
| physostigmine and amphetamine | Experimental | There is only one arm to the study. All subjects will receive physostigmine and amphetamine. Receives: Drug: Physostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Acetylcholine (ACh) Levels After Physostigmine Administration as Confirmed by PET Images.
PET images will be obtained in healthy controls and smoker subjects after physostigmine administration. Change in ACh levels will be determined by change in binding potential of Norchloro-fluoro-homoepibatidine (NCFHEB)
Measured: first 150 minute scan at baseline, second 150 minute scan start 10 minutes post physostigmine administration
Change in Dopamine (DA) Levels After Amphetamine Administration as Confirmed by PET Images.
PET images will be obtained in all subjects after amphetamine administration. Change in DA levels will be determined by change in binding potential of PHNO, a selective dopamine D2 receptor agonist.
Measured: first 120 min scan at baseline, second 120 scan 2.5 hours after amphetamine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Yale 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kelly Cosgrove, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008292
- Sponsor's protocol ID
- 1210010989/2000021470
- Other IDs
- 2R01DA015577-05, K23DA045957, R01DA038832
- Acronym
- nic_physo
- Status last verified
- Oct 2023
- First submitted
- 2 Dec 2013
- Last updated
- 25 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors
- ClinicalTrials.gov ID
- NCT02008292
- Acronym / sponsor ID
- nic_physo / 1210010989/2000021470
- Conditions
- Smoking, Schizophrenia
- Keywords
- smoking, schizophrenia, acetylcholine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2013
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Posted 6 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to measure the sensitivity of NCFHEB binding to changes in endogenous acetylcholine levels in healthy smoking and nonsmoking subjects, and in schizophrenic smoking and nonsmoking subjects. We hypothesize that physostigmine-induced elevated ACh levels will lead to a reduction in the availability of nicotinic receptors for the binding of the radioligand. We hypothesize there will be greater increase in ACh level (or greater reduction in radio tracer binding) in smoking as compared to nonsmoking subjects. We hypothesize there will be greater increase in ACh level (or greater reduction in radio tracer binding) in smoking as compared to nonsmoking subjects with schizophrenia, but the extent of this change will be different than in controls.
We are also measuring the sensitivity of PHNO binding to changes in dopamine levels in healthy smoking and nonsmoking subjects before and after amphetamine challenge.
Detailed description
- Magnetic resonance image. Within approximately two weeks of the PET study, anatomical MRIs will be acquired at the Yale University MRI Center. Subjects will be taken through a ferromagnetic metal detector before entering the scan room. The purpose of the MRI scan is to direct the region of interest placement on the lower resolution PET images. The T1 weighted images will be acquired on a 3 Tesla Siemens Scanner. There will also be an additional resting state scan with subjects in the scanner, eyes open, fixating on a cross.
- Physostigmine challenge Physostigmine will be administered as follows. Glycopyrrolate, a cholinergic antagonist that does not have central side-effects, will be administered prior to physostigmine challenge to block physostigmine peripheral side-effects (e.g. nausea). Subjects will receive 200 mcg /ml x 1 ml of glycopyrrolate through an IV. Physostigmine administered i.v. has a short half life of 20 min with peak plasma levels 20-30 min post administration. The same dose of physostigmine will be administered as in the preliminary data: 1.5 mg/hr for 1 hr. Vital signs, including systolic and diastolic blood pressure, heart rate and respiration rate, will be monitored before physostigmine and then at 10, 20, 30, 60 min after the beginning of the infusion and then hourly until the end of the study day. Subjects will be questioned before, during, and after physostigmine challenge about potential adverse reactions typical to this medication (nausea, upset stomach, etc., as in Risks section). [If there is a significant and persistent drop in subjects' heart rate (>15% for at least 1 min), the IV physostigmine infusion will be stopped but the subject will continue to be monitored and will be discharged at the discretion of the study doctor. In emergency situation, PET center protocol will be followed accordingly (on file with HIC).
- Amphetamine challenge On PHNO PET days, subjects will have a baseline PHNO scan and then will receive amphetamine by mouth (0.5mg/kg). Approximately 2.5 hours after amphetamine administration, subjects will be scanned with PHNO again.
- Positron emission tomography PET scans may be performed on the High Resolution Research Tomograph (HRRT, 2-3 mm resolution) or another similar camera. Venous catheters will be used for i.v. administration of the radiotracer, venous blood sampling of AChE activity, and for the administration of glycopyrrolate and physostigmine. A radial artery catheter will be inserted by an experienced physician before the PET scan to draw arterial blood samples for metabolite analysis and for determination of the fraction of plasma radioactivity unbound to protein. At the beginning of scan, the subject's head will be immobilized and a transmission scan will be obtained for attenuation correction. PET scans will be acquired using bolus or bolus to infusion administration of up to 10 millicuries of NCFHEB or PHNO. Dynamic images of radioactivity concentration are reconstructed with corrections for attenuation, normalization, random events, scatter, and deadtime. Subject motion is corrected automatically on an event-by-event basis with the Vicra motion tracking system. Vital signs (blood pressure, pulse and respiration) are collected prior to and during each PET scan. Urine pregnancy test will be again administered on the PET scan day prior to the initiation of any imaging procedures. Smoking abstinence, when appropriate, will also be confirmed for smoking subjects prior to PET scanning.
PET scanning will then proceed as following for each aim:
Aim 1. Subjects will be asked to come to the PET center on two separate days to participate in one NCFHEB PET scan each time to assess test retest reproducibility of binding parameters measured with the radiotracer.
Aim 2. Subjects will participate in one PET scan day. Aim 3. Subjects from Aim 2 who are able to continue smoking abstinence will be asked to come back for another PET scan after about 6-8 weeks of smoking abstinence.
Aim 4. Baseline NCFHEB PET imaging will be conducted followed by administration of physostigmine. Preferably, this will be done on the same day. However, at times there is not enough radiotracer or subject is not able to tolerate a longer scan day. Therefore, some subjects may complete the study over two separate days (preferably within 1 month apart based on the availability of PET scanning times and subject's schedule).
Aim 5. Baseline NCFHEB PET imaging will be conducted followed by administration of physostigmine. Preferably, this will be done on the same day. However, at times when there is not enough radiotracer or when a subject is not able to tolerate a longer scan day. Therefore, some subjects may complete the study over two separate days (preferably within 1 month apart based on the availability of PET scanning times and subject's schedule).
Control subjects may participate in more than 1 aim. For example, nonsmoking subjects may complete Aim 1 and if chose, participate in Aim 4. Thus, subjects may participate in up to 4 PET scans for this protocol.
Aim 7. Subjects from Aim 4 will be asked to participate in 2 PHNO PET scans and amphetamine administration.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| physostigmine and amphetamine | Experimental | Drug: PhysostigmineThere is only one arm to the study. All subjects will receive physostigmine and amphetamine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- who are able to read and write
- who are able to give voluntary written informed consent
- have no current uncontrolled medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology
- have no history of a neurological or psychiatric disorder (DSMIV Axis 1 and 2) other than schizophrenia in schizophrenia subgroup
- have not regularly used any prescription, herbal or illegal psychotropic medications (e.g. antidepressants, antipsychotics, anxiolytics, ecstasy) in the past 6 months (controls).
Key exclusion criteria (14 listed)
- Presence of acute or unstable medical or neurological illness. Subjects will be excluded from the study if they present with any history of serious medical or neurological illness or if they show signs of a major medical or neurological illness on examination or lab testing including history of seizures, head injury, brain tumor, heart, liver or kidney disease, eating disorder, diabetes.
- Presence of an Axis I diagnosis other than nicotine dependence and schizophrenia (for schizophrenia subgroup) in the past 2 years
- Regular use of any psychotropic drugs including anxiolytics and antidepressants and other over-the-counter medications and herbal products within the last year, and none within the last month for healthy controls.
- Regular use of antidepressants or psychotropic over-the-counter medications and herbal products within the last year
- For subjects with Schizophrenia, use of SSRI's (Paxil, Prozac Zoloft, Lexapro and Celexa) and use of tricyclic anti-depressants, except for a minimal dose used to treat anything other than depression, per the Investigator's discretion.
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 |
|---|---|---|
| PhysostigmineAlso: IV physostigmineAll subjects will receive physostigmine to induce elevated ACh levels in the brain. | Drug | physostigmine and amphetamine |
Primary outcome
Change in Acetylcholine (ACh) Levels After Physostigmine Administration as Confirmed by PET Images.
Time frame: first 150 minute scan at baseline, second 150 minute scan start 10 minutes post physostigmine administration
PET images will be obtained in healthy controls and smoker subjects after physostigmine administration. Change in ACh levels will be determined by change in binding potential of Norchloro-fluoro-homoepibatidine (NCFHEB)
Change in Dopamine (DA) Levels After Amphetamine Administration as Confirmed by PET Images.
Time frame: first 120 min scan at baseline, second 120 scan 2.5 hours after amphetamine administration
PET images will be obtained in all subjects after amphetamine administration. Change in DA levels will be determined by change in binding potential of PHNO, a selective dopamine D2 receptor agonist.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
Kelly Cosgrove, PhD principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physostigmine in people with Smoking and Schizophrenia, run by Yale University at 3 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 13 inclusion and 14 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 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Acetylcholine (ACh) Levels After Physostigmine Administration as Confirmed by PET Images. (time frame: first 150 minute scan at baseline, second 150 minute scan start 10 minutes post physostigmine administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.