Orthostatic IntolerancePhase 1RYGBNCT03808740

Orthostatic Intolerance After Bariatric Surgery

A Phase 1 study testing Atomoxetine in people with Orthostatic Intolerance, run by Vanderbilt University Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Orthostatic Intolerance
What is being tested?: Atomoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2018to 31 May 2021
Phase: Phase 1
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
No healthy volunteers
Adult

Who may be able to join

Obese subjects that will undergo bariatric surgery or medical weight loss.
Age 18-60 years
BMI >35 kg/m2
Weight < 400 lbs

Who cannot join

Diabetes type 1
Use of an alpha blockers, clonidine, beta-blockers.
Pregnancy or breast-feeding. Women of childbearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control.
The use of any strong CYP2D6 inhibitor (e.g., fluoxetine, paroxetine, quinidine, tipranavir).
Use of selective NET inhibitors.
Use of monoamine oxidase inhibitors.

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Cardiovascular disease such as myocardial infarction within six months prior to the study, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack
Hematocrit < 34%
Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study
Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, unlikelihood of completing the study, and investigator discretion

Trial locations and contacts

1 site in 1 country.

United States1 site

Cyndya Shibao
Nashville, Tennessee, 37027

Other trials in United States

About this study

More than 78 million adults in the U.S. are obese. Bariatric surgery is the only modality that results in sustained weight loss along with reversal of diabetes mellitus, and a decrease in cardiovascular events. Obesity is associated with increased sympathetic nervous system (SNS) activity that contributes to blood pressure regulation; sympathetic vasoconstrictor activity is maximally activated upon standing and is fundamental for the maintenance of orthostatic tolerance. After bariatric surgery, there is a significant and sustained reduction in SNS activity at three and six months after the procedure, which is related to weight loss. Recently, multiple retrospective studies have reported an orthostatic intolerance (OI) syndrome after bariatric surgery characterized by chronic pre-syncopal symptoms, syncope and orthostatic hypotension. In the Vanderbilt University Medical Center bariatric surgical center, 741 post-bariatric surgery patients reported OI symptoms, 98 (13.2%) of these patients, progressed to chronic OI and in17 cases, the OI was so disabling that patients initiated treatment with pressor agents. More than 50% of OI cases in the cohort developed the condition during a weight-stable period. Hence, investigators propose the novel hypothesis that after bariatric surgery, the persistent reduction in SNS activity contributes to impaired orthostatic tolerance, which is independent of weight loss.

Read the detailed description

Considering that SNS vasoconstrictor activity depends on synaptic norepinephrine concentrations, investigators propose a proof-of-concept study to test the hypothesis that the norepinephrine transporter (NET) inhibitor, atomoxetine, which increases synaptic norepinephrine concentrations, will improve post-bariatric OI. Understanding the changes in SNS activity and its contribution to orthostatic tolerance after bariatric surgery is of utmost importance to unravel the mechanisms of a novel and unrecognized syndrome, post-bariatric OI. In 2014, nearly 200,000 individuals in the US underwent bariatric surgery, and the number of bariatric surgery procedures is expected to increase by 22% each year. It is projected, therefore, an increase in the incidence of post-bariatric OI.

Participants with Roux-en-Y gastric bypass (RYGB) and Vertical sleeve gastrectomy (VSG) will be studied.

OI is a chronic and disabling condition; treatment is challenging because current therapies have debatable efficacy.

The proposed application will not only provide central knowledge on the pathophysiology of this new syndrome but also will fill an unmet therapeutic need by repurposing NET inhibitors for the treatment of OI.

Conditions: Orthostatic Intolerance
Being tested: Atomoxetine, Placebo
Medical subject headings: Orthostatic Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AtomoxetineDrug
Also called strattera
atomoxetine 0.5 mg/kg/day.
PlaceboDrug
Also called sugar pill
sugar pill

Study groups in NCT03808740
Study group	Role	What they receive
Roux-en-Y gastric bypass (RYGB)/Atomoxetine	Experimental	Participants with standard of care RYGB will receive atomoxetine, 0.5 mg/kg/day for 3 days Receives: Drug: Atomoxetine
Vertical sleeve gastrectomy (VSG) /Atomoxetine	Experimental	Participants with standard of care VSG will receive atomoxetine 0.5 mg/kg/day for 3 days Receives: Drug: Atomoxetine
Roux-en-Y gastric bypass (RYGB)/Placebo	Placebo comparator	Participants with standard of care RYGB will receive placebo 0.5 mg/kg/day for 3 days Receives: Drug: Placebo
Vertical sleeve gastrectomy (VSG)/ Placebo	Placebo comparator	Participants with standard of care VSG will receive placebo 0.5 mg/kg/day for 3 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months
To assess the hemodynamic (Blood Pressure) changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients.
Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope Orthostatic hemodynamics were analyzed as the area under the curve (AUC) after baseline-correction during HUT.
Measured: 0- 3 months
Cardiac Output During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months
To assess the hemodynamic (cardiac output [CO]) and cardiovascular autonomic changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients.
Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope Orthostatic hemodynamics were analyzed as the area under the curve (AUC) after baseline-correction during HUT.
Measured: 0- 3 months
Stroke Volume Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months
To assess the hemodynamic (stroke volume [SV]) and cardiovascular autonomic changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients.
Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope Orthostatic hemodynamics were analyzed as the area under the curve (AUC) after baseline-correction during HUT.
Measured: 0- 3 months
Calculated Total Peripheral Resistance During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months
To assess the hemodynamic ( total peripheral resistance [TPR]) and cardiovascular autonomic changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients.
Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope
Measured: 0- 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201831 May 2021

First posted18 Jan 2019
Study start1 Jul 2018
Primary completion31 May 2021
Study completion31 May 2021

Why it stopped: Due to COVID-19 pandemic, recruitment was stopped. All the weight loss surgeries were stopped.. Weight Loss clinic (VWL) was closed for IN person visits. We could not recruit any participant for Non surgical weight loss category.

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 Orthostatic IntoleranceStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03808740
Sponsor's protocol ID: 180499
Acronym: RYGB
Status last verified: Jun 2024
First submitted: 16 Jan 2019
Last updated: 27 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
Active, not recruitingObservational study
Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome
Active, not recruitingPhase 1/2
Treatment of Orthostatic Intolerance
Tachycardia, Chronic Orthostatic Intolerance
Active, not recruiting
Acute Salt Handling in Orthostatic Intolerance
Postural Tachycardia Syndrome, Orthostatic Tachycardia
Active, not recruiting
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
Postural Tachycardia Syndrome

All Orthostatic Intolerance trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Orthostatic Intolerance After Bariatric Surgery
ClinicalTrials.gov ID: NCT03808740
Acronym / sponsor ID: RYGB / 180499
Conditions: Orthostatic Intolerance
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to COVID-19 pandemic, recruitment was stopped. All the weight loss surgeries were stopped.. Weight Loss clinic (VWL) was closed for IN person visits. We could not recruit any participant for Non surgical weight loss category.
Enrolment: 10 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: 1 Jul 2018 (actual)
Primary completion: 31 May 2021 (actual)
Study completion: 31 May 2021 (actual)
First posted: 18 Jan 2019 (actual)
Results: Posted 27 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants with Roux-en-Y gastric bypass (RYGB) and Vertical sleeve gastrectomy (VSG) will be studied.

OI is a chronic and disabling condition; treatment is challenging because current therapies have debatable efficacy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Roux-en-Y gastric bypass (RYGB)/Atomoxetine	Experimental	Drug: AtomoxetineParticipants with standard of care RYGB will receive atomoxetine, 0.5 mg/kg/day for 3 days
Vertical sleeve gastrectomy (VSG) /Atomoxetine	Experimental	Drug: AtomoxetineParticipants with standard of care VSG will receive atomoxetine 0.5 mg/kg/day for 3 days
Roux-en-Y gastric bypass (RYGB)/Placebo	Placebo comparator	Drug: PlaceboParticipants with standard of care RYGB will receive placebo 0.5 mg/kg/day for 3 days
Vertical sleeve gastrectomy (VSG)/ Placebo	Placebo comparator	Drug: PlaceboParticipants with standard of care VSG will receive placebo 0.5 mg/kg/day for 3 days

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Obese subjects that will undergo bariatric surgery or medical weight loss.
Age 18-60 years
BMI >35 kg/m2
Weight < 400 lbs

Key exclusion criteria (12 listed)

Diabetes type 1
Use of an alpha blockers, clonidine, beta-blockers.
Pregnancy or breast-feeding. Women of childbearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control.
The use of any strong CYP2D6 inhibitor (e.g., fluoxetine, paroxetine, quinidine, tipranavir).
Use of selective NET inhibitors.

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
AtomoxetineAlso: stratteraatomoxetine 0.5 mg/kg/day.	Drug	Roux-en-Y gastric bypass (RYGB)/Atomoxetine, Vertical sleeve gastrectomy (VSG) /Atomoxetine
PlaceboAlso: sugar pillsugar pill	Drug	Roux-en-Y gastric bypass (RYGB)/Placebo, Vertical sleeve gastrectomy (VSG)/ Placebo

Primary outcome

Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months
Time frame: 0- 3 months
To assess the hemodynamic (Blood Pressure) changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients. Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope Orthostatic hemodynamics were analyzed as the area under the curve (AUC) after baseline-correction during HUT.
Cardiac Output During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months
Time frame: 0- 3 months
To assess the hemodynamic (cardiac output [CO]) and cardiovascular autonomic changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients. Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope Orthostatic hemodynamics were analyzed as the area under the curve (AUC) after baseline-correction during HUT.
Stroke Volume Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months
Time frame: 0- 3 months
To assess the hemodynamic (stroke volume [SV]) and cardiovascular autonomic changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients. Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope Orthostatic hemodynamics were analyzed as the area under the curve (AUC) after baseline-correction during HUT.
Calculated Total Peripheral Resistance During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months
Time frame: 0- 3 months
To assess the hemodynamic ( total peripheral resistance [TPR]) and cardiovascular autonomic changes during an orthostatic challenge with a head up tilt (HUT at 60 degrees) before and after bariatric surgery, at two time-points: after 10% weight loss (10% WL) and after 3 months, in morbidly obese patients. Our primary endpoint (orthostatic tolerance, OT) is defined as the time between the start of the 60 degree HUT until pre-syncope

Results and safety

Results posted to the registry on 27 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Baseline (Pre-surgery, RYGB/VSG)	10	10
Baseline Pre-hypocaloric Diet (Medical Weight Loss)	0	0

Primary outcome: Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months

Time frame: 0- 3 months. Mean (Standard Deviation). Unit: mmHg*hr

Measure	Pre- Bariatric Participants n = 10	Participants After 10% of Weight Loss n = 10	Participants After 3 Months of the Surgery n = 10
Systolic Blood pressure: analyze as Area under the curve (AUC) after baseline-correction during HUT.	113 (72.41)	56.02 (30.68)	39.4 (28.53)
Diastolic Blood pressure:analyze as Area under the curve (AUC) after baseline-correction during HUT	303.7 (93.74)	60.98 (29.54)	39.44 (28.53)

Population analysed: Orthostatic hemodynamics (SBP, DBP, HR) were analyzed as the area under the curve (AUC) after baseline-correction during HUT

Primary outcome: Cardiac Output During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months

Time frame: 0- 3 months. Mean (Standard Deviation). Unit: L/min

Measure	Pre- Bariatric Participants n = 10	Participants After 10% of Weight Loss n = 10	Participants After 3 Months of the Surgery n = 10
Value	9.124 (8.066)	3.562 (2.522)	4.916 (3.652)

Population analysed: Orthostatic hemodynamics (Cardiac Output ) were analyzed as the area under the curve (AUC) after baseline-correction during HUT

Primary outcome: Stroke Volume Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months

Time frame: 0- 3 months. Mean (Standard Deviation). Unit: mL

Measure	Pre- Bariatric Participants n = 10	Participants After 10% of Weight Loss n = 10	Participants After 3 Months of the Surgery n = 10
Value	116.2 (56.5)	148 (78.61)	105.6 (60.04)

Population analysed: Orthostatic hemodynamics (Stroke volume) were analyzed as the area under the curve (AUC) after baseline-correction during HUT

Primary outcome: Calculated Total Peripheral Resistance During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months

Time frame: 0- 3 months. Mean (Standard Deviation). Unit: mmHg*L/min

Measure	Pre- Bariatric Participants n = 10	Participants After 10% of Weight Loss n = 10	Participants After 3 Months of the Surgery n = 10
Value	9.162 (5.995)	7.239 (6.245)	9.167 (4.458)

Population analysed: Orthostatic hemodynamics (SBP, DBP, HR) were analyzed as the area under the curve (AUC) after baseline-correction during HUT

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Baseline (Pre-surgery, RYGB/VSG)	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Baseline Pre-hypocaloric Diet (Medical Weight Loss)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Orthostatic Intolerance

Enrolling by invitationObservational study
Presentation of Young Adults With and Without Joint Hypermobility
Hypermobile Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS)
Active, not recruitingObservational study
Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome
Postural Orthostatic Tachycardia Syndrome
Active, not recruitingPhase 1/2
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Active, not recruiting
Acute Salt Handling in Orthostatic Intolerance
Postural Tachycardia Syndrome, Orthostatic Tachycardia
Active, not recruiting
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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.

Cyndya Shiabao, M.D. principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atomoxetine in people with Orthostatic Intolerance, run by Vanderbilt University Medical Center 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 12 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: stopped early, as of the sponsor's last update on 27 Sep 2024. 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. Some participants in this study may receive a placebo. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2024). 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?

Blood Pressure Measurements During Orthostatic Challenge With a Head up Tilt (HUT at 60 Degrees) Before and After Bariatric Surgery: at 2 Timepoints: After 10% Weight Loss and After 3 Months (time frame: 0- 3 months). The study lists 4 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 NCT03808740.

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 27 Sep 2024.