OSAPhase 2RESCUE-ComboNCT04639193
Combination Drug-Therapy for Patients With Untreated Obstructive Sleep Apnea
A Phase 2 study testing Acetazolamide, Eszopiclone and Venlafaxine in people with OSA and Obstructive Sleep Apnea, run by University of California, San Diego at 2 sites in United States.
Trial summary
Obstructive sleep apnea (OSA) is common and associated with many adverse health consequences, but many patients are unable to tolerate standard therapies such as continuous positive airway pressure (CPAP) and thus remain untreated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- OSA, Obstructive Sleep Apnea
- What is being tested?
- Acetazolamide, Eszopiclone and Venlafaxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2020to 27 Jan 2022
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 18-40 kg/m2
- Untreated Moderate or Severe OSA (AHI during supine NREM sleep >15/h) with a fraction of hypopneas >25% of all events
Who cannot join
- Pregnancy
- Breastfeeding
- Prisoners
- Adherent with effective therapy for OSA
- Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy
- Inability to sleep supine for overnight sleep studies
Show all 20Show fewer
- Circadian rhythm disorder
- Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
- Uncontrolled hypertension (systolic blood pressure >160mmHg, diastolic blood pressure >95mmHg)
- Presence of tracheostomy
- Hospitalization within the past 90 days
- Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (< 5 years)
- Prior gastric bypass surgery
- Chronic liver disease or end-stage kidney disease
- Active illicit substance use or >2 oz daily alcohol use (i.e. >2 12 oz bottles of beers, >2 5 oz glasses of wine, >2 1.5 oz glasses of hard liquor such as spirits, gin, whiskey, etc.)
- Psychiatric disease, other than well controlled depression/anxiety
- Cognitive impairment, inability to provide consent, or inability to complete research procedures (e.g. questionnaires that are only available/validated in English)
- Chronically using study drugs or drugs with similar pharmacodynamic effects (acetazolamide - carbonic anhydrase inhibitors, eszopiclone - benzodiazepine receptor agonists, venlafaxine - serotonin/norepinephrine reuptake inhibitors and other antidepressants)
- Regular use of medications known to affect control of breathing (opioids, benzodiazepines, theophylline)
- Contraindications to taking study drugs, including allergies to any of the drugs or sulfa allergy; concomitant use of antidepressants, opioids, sedatives/hypnotics, thiazide diuretics or angiotensin-receptor blockers; or severe nocturnal hypoxia (SpO2 nadir <70% on diagnostic sleep study).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altman Clinical and Translational Research Institute Building
La Jolla, California, 92037
UCSD Health - Pulmonary and Sleep Clinic
La Jolla, California, 92121
About this study
Official title: Rescuing OSA Patients Unable to Tolerate CPAP Using Endotype-Targeted Combination Drug Therapy: a Randomized, Double-Blind, Placebo-Controlled Trial
Obstructive sleep apnea (OSA) is common and associated with many adverse health consequences, but many patients are unable to tolerate standard therapies such as continuous positive airway pressure (CPAP) and thus remain untreated. Single-drug therapies have shown promising results in treating sleep apnea, but on average patients have only experienced partial relief. Multi-drug therapy may offer a more effective treatment approach. The goal of this study is to test the effect of combination therapy with three FDA-approved drugs (Diamox [acetazolamide], Lunesta [eszopiclone] +/- Effexor [venlafaxine]) on OSA severity and physiology.
Read the detailed description
Study participants will undergo three 3-day drug regimens. On days 1 and 2 of each drug regimen, subjects will take the study drugs at home; on day 3 of each drug regimen subjects will take the study drugs as part of an overnight inlab sleep study (including assessments of sleepiness/alertness, sleep quality and blood pressure). Initially subjects will take dual-therapy (acetazolamide+eszopiclone) vs placebo in random order; if sleep apnea resolved with dual-therapy, then subjects will undergo an open-label single-drug regimen (acetazolamide), else an open-label triple-drug regimen (acetazolamide + eszopiclone + venlafaxine).
- Conditions
- OSA, Obstructive Sleep Apnea
- Being tested
- Acetazolamide, Eszopiclone, Placebo, Venlafaxine
- Keywords
- sleep, drug
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Diamox
Acetazolamide tablet (encapsulated)
EszopicloneDrug
Also called Lunesta
Eszopiclone tablet (encapsulated)
PlaceboDrug
Sugar capsule manufactured to match encapsulated Acetazolamide/Eszopiclone
VenlafaxineDrug
Also called Effexor
Venlafaxine capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo, then Dual-Therapy, then Single/Triple-Therapy | Experimental | Subjects will start with a 3-day PLACEBO regimen:
* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.
* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.
* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.
After a wash-out period of 4+ days, subjects will then cross-over to a 3-day EXPERIMENTAL DUAL-regimen:
* Day 1: Acetazolamide 250mg at bedtime at home.
* Day 2: Acetazolamide 500mg at bedtime at home.
* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.
After a wash-out period of 4+ days, subjects will then undergo an OPEN-LABEL SINGLE/TRIPLE-regimen:
* Day 1: Acetazolamide 250mg at bedtime at home.
* Day 2: Acetazolamide 500mg at bedtime at home.
* Day 3: Acetazolamide 500mg alone or Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory, if sleep apnea resolved or did not resolve with the dual regimen, respectively. Receives: Drug: Acetazolamide; Drug: Eszopiclone; Drug: Placebo; Drug: Venlafaxine |
| Dual-Therapy, then Placebo, then Single/Triple-Therapy | Experimental | Subjects will start with a 3-day EXPERIMENTAL DUAL-regimen:
* Day 1: Acetazolamide 250mg at bedtime at home.
* Day 2: Acetazolamide 500mg at bedtime at home.
* Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory.
After a wash-out period of 4+ days, subjects will then cross-over to a 3-day PLACEBO regimen:
* Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home.
* Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home.
* Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory.
After a wash-out period of 4+ days, subjects will then undergo an OPEN-LABEL SINGLE/TRIPLE-regimen:
* Day 1: Acetazolamide 250mg at bedtime at home.
* Day 2: Acetazolamide 500mg at bedtime at home.
* Day 3: Acetazolamide 500mg alone or Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory, if sleep apnea resolved or did not resolve with the dual regimen, respectively. Receives: Drug: Acetazolamide; Drug: Eszopiclone; Drug: Placebo; Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
The AHI is a measure of sleep apnea severity and based on the American Academy of Sleep Medicine (AASM)-recommended criteria is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a >=3% desaturation or cortical arousal) per hour of sleep. To avoid confounding by sleep stages and positions across study nights the primary focus was on the AHI during supine non rapid eye movement (NREM) sleep. For comparability with other studies, we also explored the AASM-acceptable "AHI4", which defines hypopneas as reduced breathing for 10+ seconds associated with a >=4% desaturation.
Measured: 3 nights
Secondary outcomes (9)
SpO2 Nadir
The lowest measured blood oxygen saturation during the overnight sleep study measured in percent.
Measured: 3 nights
Pathophysiological Traits: Vpassive, Vactive, Arousal Threshold
Pathophysiological traits were quantified as %Veupnea from polysomnography data using a validated algorithm.
Measured: 3 nights
Pathophysiological Trait: Loop Gain
Loop Gain 1 was quantified from polysomnography data using a validated algorithm. This metric measures the increase in respiratory drive relative to a preceding drop in ventilation and thus is dimensionless (typical range is approximately 0.2 to 1.5, with values >0.7 being considered high loop gain, indicating ventilatory instability)
Measured: 3 nights
Percent Responders
Full responders were defined as a drop in AHI>50% to <10/h.
Measured: 3 nights
Blood Pressure
Systolic/Diastolic Blood Pressure (measured at rest in the morning following the overnight sleep study).
Measured: 3 nights
Subjective Sleepiness: Stanford Sleepiness Scale (SSS)
Subjective sleepiness was assessed using the Stanford Sleepiness Scale (SSS) in the morning following the overnight sleep study. The score ranges from 1 to 7, with greater values indicating more sleepiness.
Measured: 3 nights
Sleep Quality: PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance
Sleep quality was assessed based on a modified 8-question PROMIS Sleep Disturbance (SDA 8b) questionnaire in the morning following the overnight sleep study. The raw score ranges from 8 to 40 and is translated into a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Greater T-scores indicate greater sleep disturbance.
Measured: 3 nights
Psychomotor Vigilance: Response Speed
Vigilance was assessed using the 10-minute psychomotor vigilance test (PVT) in the morning following the overnight sleep study. Primary focus was on "response speed" 1/reaction time (1/RT) and lapses (reaction time >500ms).
Measured: 3 nights
Psychomotor Vigilance: Lapses
Vigilance was assessed using the 10-minute psychomotor vigilance test (PVT) in the morning following the overnight sleep study. Primary focus was on "response speed" 1/reaction time (1/RT) and lapses (reaction time >500ms).
Measured: 3 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Dec 2020
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
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 (1)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled, cross-over trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- American Thoracic Society
- Responsible party
- Principal investigator, Christopher Schmickl, University of California, San Diego
- Investigators
- Christopher Schmickl, MD, PhD, Principal investigator, Associate Physician and Postdoctoral Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639193
- Sponsor's protocol ID
- 191990
- Acronym
- RESCUE-Combo
- Status last verified
- May 2024
- First submitted
- 12 Nov 2020
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmickl CN, Orr JE, Alex RM, Gruenberg E, Parra G, White S, Spenceley A, DeSarkar T, Kong M, DeYoung PN, Sands SA, Owens RL, Malhotra A. Combination Drug Therapy with Acetazolamide, Eszopiclone +/- Venlafaxine for Obstructive Sleep Apnea (RESCUE-Combo): A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Ann Am Thorac Soc. 2025 Feb;22(2):263-273. doi: 10.1513/AnnalsATS.202407-736OC.
PubMed 39514000
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescuing OSA Patients Unable to Tolerate CPAP Using Endotype-Targeted Combination Drug Therapy: a Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04639193
- Acronym / sponsor ID
- RESCUE-Combo / 191990
- Conditions
- OSA, Obstructive Sleep Apnea
- Keywords
- sleep, drug
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- American Thoracic Society
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Posted 2 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is common and associated with many adverse health consequences, but many patients are unable to tolerate standard therapies such as continuous positive airway pressure (CPAP) and thus remain untreated. Single-drug therapies have shown promising results in treating sleep apnea, but on average patients have only experienced partial relief. Multi-drug therapy may offer a more effective treatment approach. The goal of this study is to test the effect of combination therapy with three FDA-approved drugs (Diamox [acetazolamide], Lunesta [eszopiclone] +/- Effexor [venlafaxine]) on OSA severity and physiology.
Detailed description
Study participants will undergo three 3-day drug regimens. On days 1 and 2 of each drug regimen, subjects will take the study drugs at home; on day 3 of each drug regimen subjects will take the study drugs as part of an overnight inlab sleep study (including assessments of sleepiness/alertness, sleep quality and blood pressure). Initially subjects will take dual-therapy (acetazolamide+eszopiclone) vs placebo in random order; if sleep apnea resolved with dual-therapy, then subjects will undergo an open-label single-drug regimen (acetazolamide), else an open-label triple-drug regimen (acetazolamide + eszopiclone + venlafaxine).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, cross-over trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo, then Dual-Therapy, then Single/Triple-Therapy | Experimental | Drug: Acetazolamide, Drug: Eszopiclone, Drug: Placebo, Drug: VenlafaxineSubjects will start with a 3-day PLACEBO regimen: * Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home. * Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home. * Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory. After a wash-out period of 4+ days, subjects will then cross-over to a 3-day EXPERIMENTAL DUAL-regimen: * Day 1: Acetazolamide 250mg at bedtime at home. * Day 2: Acetazolamide 500mg at bedtime at home. * Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory. After a wash-out period of 4+ days, subjects will then undergo an OPEN-LABEL SINGLE/TRIPLE-regimen: * Day 1: Acetazolamide 250mg at bedtime at home. * Day 2: Acetazolamide 500mg at bedtime at home. * Day 3: Acetazolamide 500mg alone or Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory, if sleep apnea resolved or did not resolve with the dual regimen, respectively. |
| Dual-Therapy, then Placebo, then Single/Triple-Therapy | Experimental | Drug: Acetazolamide, Drug: Eszopiclone, Drug: Placebo, Drug: VenlafaxineSubjects will start with a 3-day EXPERIMENTAL DUAL-regimen: * Day 1: Acetazolamide 250mg at bedtime at home. * Day 2: Acetazolamide 500mg at bedtime at home. * Day 3: Acetazolamide 500mg + Eszopiclone 2mg at bedtime in the sleep laboratory. After a wash-out period of 4+ days, subjects will then cross-over to a 3-day PLACEBO regimen: * Day 1: Placebo (matching Acetazolamide 250mg) at bedtime at home. * Day 2: Placebo (matching Acetazolamide 500mg) at bedtime at home. * Day 3: Placebo (matching Acetazolamide 500mg + Eszopiclone 2mg) at bedtime in the sleep laboratory. After a wash-out period of 4+ days, subjects will then undergo an OPEN-LABEL SINGLE/TRIPLE-regimen: * Day 1: Acetazolamide 250mg at bedtime at home. * Day 2: Acetazolamide 500mg at bedtime at home. * Day 3: Acetazolamide 500mg alone or Acetazolamide 500mg + Eszopiclone 2mg + Venlafaxine 50mg at bedtime in the sleep laboratory, if sleep apnea resolved or did not resolve with the dual regimen, respectively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 18-40 kg/m2
- Untreated Moderate or Severe OSA (AHI during supine NREM sleep >15/h) with a fraction of hypopneas >25% of all events
Key exclusion criteria (20 listed)
- Pregnancy
- Breastfeeding
- Prisoners
- Adherent with effective therapy for OSA
- Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy
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 |
|---|---|---|
| AcetazolamideAlso: DiamoxAcetazolamide tablet (encapsulated) | Drug | Dual-Therapy, then Placebo, then Single/Triple-Therapy, Placebo, then Dual-Therapy, then Single/Triple-Therapy |
| EszopicloneAlso: LunestaEszopiclone tablet (encapsulated) | Drug | Dual-Therapy, then Placebo, then Single/Triple-Therapy, Placebo, then Dual-Therapy, then Single/Triple-Therapy |
| PlaceboSugar capsule manufactured to match encapsulated Acetazolamide/Eszopiclone | Drug | Dual-Therapy, then Placebo, then Single/Triple-Therapy, Placebo, then Dual-Therapy, then Single/Triple-Therapy |
| VenlafaxineAlso: EffexorVenlafaxine capsule | Drug | Dual-Therapy, then Placebo, then Single/Triple-Therapy, Placebo, then Dual-Therapy, then Single/Triple-Therapy |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: 3 nights
The AHI is a measure of sleep apnea severity and based on the American Academy of Sleep Medicine (AASM)-recommended criteria is defined as the number of apneas (no breathing for 10+ seconds) and hypopneas (reduced breathing for 10+ seconds associated with a >=3% desaturation or cortical arousal) per hour of sleep. To avoid confounding by sleep stages and positions across study nights the primary focus was on the AHI during supine non rapid eye movement (NREM) sleep. For comparability with other studies, we also explored the AASM-acceptable "AHI4", which defines hypopneas as reduced breathing for 10+ seconds associated with a >=4% desaturation.
9 secondary outcomes
SpO2 Nadir
Time frame: 3 nights
Pathophysiological Traits: Vpassive, Vactive, Arousal Threshold
Time frame: 3 nights
Pathophysiological Trait: Loop Gain
Time frame: 3 nights
Percent Responders
Time frame: 3 nights
Blood Pressure
Time frame: 3 nights
Subjective Sleepiness: Stanford Sleepiness Scale (SSS)
Time frame: 3 nights
Sleep Quality: PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance
Time frame: 3 nights
Psychomotor Vigilance: Response Speed
Time frame: 3 nights
Psychomotor Vigilance: Lapses
Time frame: 3 nights
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39514000Schmickl CN, Orr JE, Alex RM, Gruenberg E, Parra G, White S, Spenceley A, DeSarkar T, Kong M, DeYoung PN, Sands SA, Owens RL, Malhotra A. Combination Drug Therapy with Acetazolamide, Eszopiclone +/- Venlafaxine for Obstructive Sleep Apnea (RESCUE-Combo): A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Ann Am Thorac Soc. 2025 Feb;22(2):263-273. doi: 10.1513/AnnalsATS.202407-736OC.
- 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. This study is not recruiting at the moment.
Christopher Schmickl, MD, PhD principal investigator
Associate Physician and Postdoctoral Fellow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetazolamide, Eszopiclone and Venlafaxine in people with OSA and Obstructive Sleep Apnea, run by University of California, San Diego 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 2 inclusion and 20 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 May 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?
Apnea Hypopnea Index (AHI) (time frame: 3 nights). 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 NCT04639193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.