Critical IllnessPhase 2/3NCT02819141

Self-management of Sedative Therapy by Ventilated Patients

A Phase 2/3 study testing Dexmedetomidine in people with Critical Illness and Anxiety, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Critical Illness, Anxiety, Respiratory Failure
What is being tested?: Dexmedetomidine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 161 participants
Where: 2 sitesUnited States
Study dates: Nov 2016to Dec 2024
Phase: Phase 2/3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is acutely mechanically ventilated during the current hospitalization.
Subject is currently receiving a continuous intravenous infusion of a sedative/opioid medication(s) or has received at least one intravenous bolus dose of a sedative/opioid medication in the previous 24 hours (fentanyl, hydromorphone, ketamine, morphine, midazolam, diazepam, lorazepam, propofol, haloperidol, dexmedetomidine).
Subject must pass pre-Patient-Controlled Sedation (PCS) screening test and be assessed Richmond Agitation-Sedation Scale (RASS) -2 to +1
Subject Age ≥ 18 years
Subject or their proxy is capable of providing informed consent

Who cannot join

Aggressive ventilatory support or prone ventilation.
Hypotension (systolic blood pressure < 85 mmHg) requiring a vasopressor at a dose greater than norepinephrine or epinephrine 0.15 mcg/kg/min or vasopressin > 2.4 units per hour. Subjects will be excluded if they require more than one continuous infusion of a catecholamine vasopressor medication simultaneously. Subjects will be excluded if the vasopressor dose was higher than norepinephrine or epinephrine 0.15 mcg/kg/min, vasopressin > 2.4 units per hour, phenylephrine >3 mcg/kg/min, dopamine >10 mcg/kg/min or dobutamine at any dose in the prior 6 hours. If dopamine is being used to increase heart rate, rather than as a vasopressor for hypotension, subject will be excluded.
Second or third degree heart block or bradycardia (heart rate < 50 beats/min).
Paralysis or other condition preventing the use of push button device
Positive pregnancy test or lactation
Acute hepatitis or liver failure (direct bilirubin >5 mg/dL)

Show all 12Show fewer

Acute stroke or uncontrolled seizures.
Acute myocardial infarction within 48 hours prior to enrollment.
Severe cognition or communication problems (such as coma, deafness without signing literacy, physician-documented dementia)
Assessed RASS -3, -4, -5 or RASS +2,+3, +4
Chronic ventilator support in place of residence prior to current hospitalization.
Imminent extubation from mechanical ventilator support.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

School of Medicine, University of Minnesota
Minneapolis, Minnesota, 55455
Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients

The purpose of this randomized clinical trial is to test the efficacy of dexmedetomidine for the self-management of sedative therapy (SMST) in a sample of critically ill patients receiving mechanical ventilator support. The investigators hypothesis is that self-management of sedative therapy by mechanically ventilated patients in the intensive care unit (ICU), tailored to their individual needs will be more efficacious than nurse-administered sedative therapy in reducing anxiety, which may reduce duration of mechanical ventilator support and occurrence of delirium.

Read the detailed description

The overall objective of this study is to demonstrate efficacy for conducting a future, pragmatic effectiveness trial to test whether self-management of sedative therapy (SMST) is superior to nurse-administered sedative therapy in day-to-day intensive care unit (ICU) practice. This efficacy trial is powered for the investigators primary, clinically relevant endpoints (anxiety, duration of mechanical ventilation, and delirium presence), and examines patient outcomes adversely affected by sedative administration practices, such as prolonged ICU stays, altered mental status, and diminished post-ICU quality of life. This randomized clinical trial with a total of 190 mechanically ventilated patients enrolled and maintained on protocol will address the following Specific Aims.

The primary aim is to determine the efficacy of SMST compared to nurse-administered sedative therapy on anxiety, duration of mechanical ventilation, and presence of delirium in mechanically ventilated patients (MVPs).

The secondary aim is to compare level of arousal and sedative exposure in mechanically ventilated patients (MVPs) randomized to SMST to those MVPs receiving nurse-administered sedative therapy. The investigators hypothesize that SMST patients will be easily arousable, more alert, and exposed to less sedation than those who receive nurse-administered sedative therapy.

Exploratory aims are to compare post-ICU outcomes (physical/functional status, psychological well-being, and health-related quality of life) and recall of ICU experiences between MVPs randomized to SMST and those receiving nurse-administered sedative therapy.

Conditions: Critical Illness, Anxiety, Respiratory Failure
Being tested: Dexmedetomidine
Medical subject headings: Critical Illness, Anxiety Disorders, Respiratory Insufficiency

What participants receive

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

DexmedetomidineDrug
Also called Precedex
Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.

Study groups in NCT02819141
Study group	Role	What they receive
Control	No intervention	These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team
Dexmedetomidine	Experimental	These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety. Receives: Drug: Dexmedetomidine

What is being measured

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

Anxiety Rating Using the 100mm Vertical Visual Analog Scale
Vertical visual analog scale will be used to measure level of state anxiety from 0/zero (no anxiety) to 100 (most anxiety ever). Higher scores mean more anxiety.
Measured: 7 days
Duration of Mechanical Ventilatory Support After Study Enrollment
Duration of time (hours) patients received mechanical ventilatory support after randomization to either Control or dexmedetomidine self-management of sedative therapy to extubation.
Measured: 7 days
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU)
Confusion Assessment Method-ICU (CAM-ICU) used to assess for the presence (CAM-ICU+) or absence (CAM-ICU-) of delirium at each assessment.
Measured: 7 days

Secondary outcomes (3)

Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS)
The Richmond Agitation-Sedation Scale (RASS) was used to assess the level of alertness and agitation in enrolled patients. Scores range from -5 to +4. RASS 0/zero indicates alert and calm patient. Negative scores (-1 to -5) indicate increasing level of sedation with -5 indicating unarousable. Positive scores indicate increasing agitation (+1 to +4) with +4 indicating a combative patient. For enrolled study patients, RASS score -2 (light sedation) to +1 (restless) was considered in range. We report here the total number of patients assessed as outside the desirable range of RASS score -5 to -3 and +2 to +4 by each ICU study day.
Measured: 7 days
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients.
Sedation intensity combines the number of sedative doses and the dose amount of any of 9 intravenous (IV) sedative medications (lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine) recorded in the electronic health record, summarized over all patients and time periods each day to obtain medians and quartiles. Each of the 9 sedative drugs administered during each 4-hr period is then assigned a ranking: 0 for drug not used, 1 for the bottom quartile, 2 for the second quartile, 3 for the third, and 4 for the fourth. A score is determined by summing for the 24-hr day over the 6, 4-hour blocks to produce a daily Sedation Intensity Score from 0-36, higher score more intense dosing received of sedative medications.
Measured: Daily Sedation intensity over a 7-day ICU study protocol period
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients.
Sedation Frequency is the number of individual intravenous (IV) sedative medication(s) doses administered to patients over each 24-hour day of lorazepam, midazolam, propofol, morphine, hydromorphone, dexmedetomidine, fentanyl, haloperidol, ketamine. Sedation frequency ranges from 0-216 with a higher number indicating more frequent receipt of a sedative medication(s).
Measured: Daily Sedation Frequency over a 7-day ICU study protocol period

Timeline

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

Nov 2016Dec 2024

First posted30 Jun 2016 (estimated)
Study startNov 2016
Primary completionOct 2024
Study completionDec 2024

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Critical IllnessStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 161 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02819141
Sponsor's protocol ID: 16-000417
Other IDs: 5R01HL130881
Status last verified: Sep 2025
First submitted: 23 Jun 2016
Last updated: 2 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Tracy MF, Chlan L, Savik K, Skaar DJ, Weinert C. A Novel Research Method for Determining Sedative Exposure in Critically Ill Patients. Nurs Res. 2019 Jan/Feb;68(1):73-79. doi: 10.1097/NNR.0000000000000322.
PubMed 30540694
Chlan LL, Weinert CR, Tracy MF, Skaar DJ, Gajic O, Ask J, Mandrekar J. Study protocol to test the efficacy of self-administration of dexmedetomidine sedative therapy on anxiety, delirium, and ventilator days in critically ill mechanically ventilated patients: an open-label randomized clinical trial. Trials. 2022 May 16;23(1):406. doi: 10.1186/s13063-022-06391-w.
PubMed 35578315
Chlan LL, Tracy MF, Ask J, Lal A, Mandrekar J. The impact of the COVID-19 pandemic on ICU clinical trials: a description of one research team's experience. Trials. 2023 May 11;24(1):321. doi: 10.1186/s13063-023-07355-4.
PubMed 37165383

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

RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness

All Critical Illness trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients
ClinicalTrials.gov ID: NCT02819141
Acronym / sponsor ID: 16-000417
Conditions: Critical Illness, Anxiety, Respiratory Failure
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 161 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: University of Minnesota, National Heart, Lung, and Blood Institute (NHLBI)
Study start: Nov 2016 (actual)
Primary completion: Oct 2024 (actual)
Study completion: Dec 2024 (actual)
First posted: 30 Jun 2016 (estimated)
Results: Posted 2 Oct 2025

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team
Dexmedetomidine	Experimental	Drug: DexmedetomidineThese patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject is acutely mechanically ventilated during the current hospitalization.
Subject is currently receiving a continuous intravenous infusion of a sedative/opioid medication(s) or has received at least one intravenous bolus dose of a sedative/opioid medication in the previous 24 hours (fentanyl, hydromorphone, ketamine, morphine, midazolam, diazepam, lorazepam, propofol, haloperidol, dexmedetomidine).
Subject must pass pre-Patient-Controlled Sedation (PCS) screening test and be assessed Richmond Agitation-Sedation Scale (RASS) -2 to +1
Subject Age ≥ 18 years
Subject or their proxy is capable of providing informed consent

Key exclusion criteria (12 listed)

Aggressive ventilatory support or prone ventilation.
Hypotension (systolic blood pressure < 85 mmHg) requiring a vasopressor at a dose greater than norepinephrine or epinephrine 0.15 mcg/kg/min or vasopressin > 2.4 units per hour. Subjects will be excluded if they require more than one continuous infusion of a catecholamine vasopressor medication simultaneously. Subjects will be excluded if the vasopressor dose was higher than norepinephrine or epinephrine 0.15 mcg/kg/min, vasopressin > 2.4 units per hour, phenylephrine >3 mcg/kg/min, dopamine >10 mcg/kg/min or dobutamine at any dose in the prior 6 hours. If dopamine is being used to increase heart rate, rather than as a vasopressor for hypotension, subject will be excluded.
Second or third degree heart block or bradycardia (heart rate < 50 beats/min).
Paralysis or other condition preventing the use of push button device
Positive pregnancy test or lactation

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
DexmedetomidineAlso: PrecedexPatient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.	Drug	Dexmedetomidine

Primary outcome

Anxiety Rating Using the 100mm Vertical Visual Analog Scale
Time frame: 7 days
Vertical visual analog scale will be used to measure level of state anxiety from 0/zero (no anxiety) to 100 (most anxiety ever). Higher scores mean more anxiety.
Duration of Mechanical Ventilatory Support After Study Enrollment
Time frame: 7 days
Duration of time (hours) patients received mechanical ventilatory support after randomization to either Control or dexmedetomidine self-management of sedative therapy to extubation.
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU)
Time frame: 7 days
Confusion Assessment Method-ICU (CAM-ICU) used to assess for the presence (CAM-ICU+) or absence (CAM-ICU-) of delirium at each assessment.

3 secondary outcomes

Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS)
Time frame: 7 days
Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients.
Time frame: Daily Sedation intensity over a 7-day ICU study protocol period
Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients.
Time frame: Daily Sedation Frequency over a 7-day ICU study protocol period

Results and safety

Results posted to the registry on 2 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	81	75
Dexmedetomidine	80	60

Primary outcome: Anxiety Rating Using the 100mm Vertical Visual Analog Scale

Time frame: 7 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Control n = 81	Dexmedetomidine n = 80
Day 1 morning	44.4 (33.2)	43.4 (33.4)
Day 1 afternoon	40.5 (31.8)	33.1 (30.9)
Day 1 evening	45.1 (32.4)	40.9 (35.7)
Day 2 morning	49.8 (30.9)	44.6 (34.4)
Day 2 afternoon	41.9 (33.4)	41.4 (38.5)
Day 2 evening	50.9 (32.7)	54.9 (36.3)
Day 3 morning	48 (35.0)	49.8 (39.8)
Day 3 afternoon	43.3 (33.9)	58.6 (40.1)

Control vs Dexmedetomidine: p = 0.30, Generalized estimating equations
Control vs Dexmedetomidine: p = 0.9858, Generalized Estimating equations

Population analysed: Not all enrolled patients able to respond to each assessment time point for anxiety ratings. They may have been extubated and completed the ICU study phase, withdrew from the study, or died.

Primary outcome: Duration of Mechanical Ventilatory Support After Study Enrollment

Time frame: 7 days. Mean (Standard Deviation). Unit: hours

Measure	Control n = 81	Dexmedetomidine n = 80
Value	68.7 (58.2)	50.3 (52.8)

Control vs Dexmedetomidine: p = 0.02, t-test, 1 sided

Population analysed: Includes all patients enrolled who were randomized using an Intention to treat analysis

Primary outcome: Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU)

Time frame: 7 days. Number. Unit: participants CAM-ICU+

Measure	Control n = 81	Dexmedetomidine n = 80
Study entry CAM-ICU+	15	7
Day #1 CAM-ICU+	14	10
Day #2 CAM-ICU+	9	5
Day #3 CAM-ICU+	8	3
Day #4 CAM-ICU+	2	2
Day #5 CAM-ICU+	2	2
Day #6 CAM-ICU+	0	4
Day #7 CAM-ICU+	0	2

Control vs Dexmedetomidine: p = 0.97, Generalized estimating equations
Control vs Dexmedetomidine: p = 0.5647, Generalized estimating equations

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event Data were collected from study enrollment day 0 to day 7 of the ICU phase plus an additional 24 hours after completion of the 7-day ICU phase for a total maximum of 8 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	5 of 81 (6.2%)	29 of 81 (35.8%)	1 of 81
Dexmedetomidine	12 of 80 (15%)	24 of 80 (30%)	0 of 80

Limitations and caveats (from the sponsor): The corona virus (COVID-19) global pandemic adversely impacted the ICU clinical trial. The pandemic influenced many aspects of patient availability for enrollment, changes to patient management including sedation regimens and clinical practice in the care of critically ill patients receiving mechanical ventilatory support. Fewer than planned patients randomized to dexmedetomidine self-management of sedative therapy actually received the experimental intervention, resulting in unbalanced numbers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30540694Tracy MF, Chlan L, Savik K, Skaar DJ, Weinert C. A Novel Research Method for Determining Sedative Exposure in Critically Ill Patients. Nurs Res. 2019 Jan/Feb;68(1):73-79. doi: 10.1097/NNR.0000000000000322.
Background: PubMed 35578315Chlan LL, Weinert CR, Tracy MF, Skaar DJ, Gajic O, Ask J, Mandrekar J. Study protocol to test the efficacy of self-administration of dexmedetomidine sedative therapy on anxiety, delirium, and ventilator days in critically ill mechanically ventilated patients: an open-label randomized clinical trial. Trials. 2022 May 16;23(1):406. doi: 10.1186/s13063-022-06391-w.
Background: PubMed 37165383Chlan LL, Tracy MF, Ask J, Lal A, Mandrekar J. The impact of the COVID-19 pandemic on ICU clinical trials: a description of one research team's experience. Trials. 2023 May 11;24(1):321. doi: 10.1186/s13063-023-07355-4.
Individual participant dataSharing planned: No

Related trials for Critical Illness

RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness

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.

Linda L Chlan, RN, PhD principal investigator

Mayo Clinic

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dexmedetomidine in people with Critical Illness and Anxiety, run by Mayo Clinic 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 5 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: finished, as of the sponsor's last update on 2 Oct 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 2 Oct 2025). 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?

Anxiety Rating Using the 100mm Vertical Visual Analog Scale (time frame: 7 days). 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 NCT02819141, which also lists 3 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 2 Oct 2025.