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Sleep Apnea, ObstructivePhase 1NCT04647383

A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Phase 1 study testing Lemborexant 10 mg in people with Sleep Apnea, Obstructive and Pulmonary Disease, Chronic Obstructive, run by Eisai Inc. at 11 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

The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to [>=] 45 to less than [<] 65 years; elderly >=65 to 90 years) with moderate to severe obstructive sleep apnea (OSA)… Read more about this study

Who is it for?
Ages 45 to 90 years
What is being tested?
Lemborexant 10 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
11 sitesUnited States
Study dates
6 Jan 2021to 10 Feb 2022
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 45 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age >=45 and <=90 at the time of informed consent
  • Voluntary agreement and ability to provide written informed consent
  • Body mass index (BMI) <40 Kilogram per meter square (kg/m^2)
  • Reports habitually sleeping for at least 5.5 hours per night
  • Reports habitual bedtime between 21:00 and midnight
  • Agrees to stay in bed for 7 hours per night for the duration of the study
Show all 23Show fewer
  • At Screening Visit 2: Has completed the sleep diary for at least 5 consecutive nights
  • At Screening Visit 2: Confirmation of mean habitual bedtime (MHB) between 21:00 and midnight (sleep diary)
  • Additional Inclusion Criteria (OSA Cohort)
  • Moderate to severe OSA diagnosed according to the criteria of the ICSD, confirmed by PSG (home sleep testing by portable monitor is acceptable) within the previous 5 years or a repeated PSG during screening
  • On screening PSG: moderate OSA (defined as 15 <=AHI <30) or severe OSA (defined as AHI >=30 per hour)
  • SpO2 >=94% assessed as part of vital signs at Screening Visit 1
  • Additional Inclusion Criteria (COPD Cohort)
  • Screening spirometry performed as per the Global Initiative for Obstructive Lung Disease (GOLD) recommendations
  • On screening spirometry, based on post-bronchodilator Forced Expiratory Volume in 1 second (FEV1):
  • FEV1/Forced Vital Capacity (FVC) <0.70 and one of the following:
  • 50% <=FEV1 <80% predicted (GOLD 2 Classification for moderate COPD) or
  • 30% <=FEV1 <50% predicted (GOLD 3 Classification for severe COPD)
  • Moderate to severe COPD according to medical history and screening spirometry as per the GOLD criteria (GOLD 2019)
  • On screening PSG
  • AHI <15
  • SpO2 during wakefulness >90% (both supine and sitting)
  • SpO2 during sleep >=80% for at least 75% of the recording period with no more than five continuous minutes <80% and with no SpO2 readings <70%

Who cannot join

  • Females of childbearing potential
  • A current diagnosis of restless legs syndrome, periodic limb movement disorder, circadian rhythm sleep disorder, or narcolepsy
  • Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicate the need for referral for a diagnostic evaluation for the presence of narcolepsy
  • A history of symptoms of rapid eye movement (REM) Behavior Disorder, sleep-related violent behavior, sleep-driving, or sleep-eating, or symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study
  • Periodic Limb Movement with Arousal Index (PLMAI) as measured on the screening
  • PSG:
Show all 45Show fewer
  • Age 18 to <65 years: PLMAI >=10
  • Age >65 years: PLMAI >15
  • A prolonged QT interval by Fredericia (QTcF) (QTcF >450 milliseconds [ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening
  • Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS])
  • Any lifetime suicidal behavior (per the Suicidal Behavior section of the C-SSRS) within 10 years of Screening
  • Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
  • Hypersensitivity to the study drug or any of the excipients
  • Used any prohibited prescription or over-the-counter medications within 1 week or 5 half-lives, whichever is longer, before the screening PSG
  • Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study
  • Scheduled for surgery during the study that requires general anesthesia or administration of prohibited medications
  • Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics or prior suicide attempt(s) within approximately the last 2 years
  • History of drug or alcohol dependency or abuse within approximately the last 2 years
  • Use of illegal recreational drugs (includes marijuana, regardless of whether prescribed for medicinal use)
  • Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5*the half-life, whichever is longer preceding informed consent
  • Previously participated in other clinical trial of lemborexant
  • Exposure within the last 14 days to an individual with confirmed or probable corona virus disease 2019 (COVID-19) or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention (CDC) list of COVID symptoms or any other reason to consider the participant at potential risk for an acute COVID-19 infection
  • Additional Exclusion Criteria (OSA Cohort)
  • SpO2 <80% for >=5% of TST during the screening PSG
  • Use of a continuous positive airway pressure (CPAP) device or dental appliance within 2 weeks of the screening PSG, and does not agree to abstain from the use of a CPAP device or dental appliance from the
  • Current evidence of a clinically significant, active respiratory disorder other than OSA. This includes bronchiectasis, emphysema, asthma, COPD or any other pulmonary disorder identified by review of medical history, physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments
  • Current evidence of other clinically significant disease (example, psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality), malignancy within the past 5 years (other than adequately treated basal cell carcinoma or in situ carcinoma of the cervix), or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments. Screening Visit through the last study visit
  • Additional Exclusion Criteria (COPD Cohort)
  • Use of continuous (>16 hours/day) oxygen therapy
  • Use of oxygen therapy during PSG
  • Determination that, in the opinion of the investigator, removal of oxygen therapy could affect the participant's safety or interfere with the study assessments
  • Recent changes to COPD medications or recent acute exacerbation of COPD (that is, needing hospitalization or treatment with oral corticosteroids and/or antibiotics) within 3 months of enrollment
  • On screening spirometry (COPD only):
  • FEV1/FVC >=0.70
  • FEV1 >=80% predicted (GOLD 1 Classification for mild COPD)
  • FEV1 <30% predicted (GOLD 4 Classification for very severe COPD)
  • On screening PSG (COPD only):
  • Moderate to severe OSA (AHI >=15)
  • SpO2 <90% during wakefulness (supine and sitting)
  • SpO2 during sleep <80% for 25% or more of the recording with >5 consecutive minutes <80% and any SpO2 reading <70%
  • ECG evidence of right ventricular hypertrophy or right heart failure
  • Screening hematocrit >55%
  • Use of a CPAP device or dental appliance within 2 weeks of the screening PSG, and does not agree to abstain from the use of a CPAP device or dental appliance from the Screening Visit through the last study visit
  • Current evidence of a clinically significant, active respiratory disorder other than COPD and mild OSA. This includes any other pulmonary disorder identified by review of medical history, physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments.
  • Current evidence of other clinically significant disease other than COPD and mild OSA (example, psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality), malignancy within the past 5 years (other than adequately treated basal cell carcinoma or in situ carcinoma of the cervix), or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • NeuroTrials Research Inc.

    Atlanta, Georgia, 30328

  • Teradan Clinical Trials

    Brandon, Florida, 33511

  • CTI Clinical Trial & Consulting Services

    Cincinnati, Ohio, 45212

  • Intrepid Research, LLC

    Cincinnati, Ohio, 45245

  • St. Francis Medical Institute

    Clearwater, Florida, 33765

  • Pulmonary Associates

    Glendale, Arizona, 85306

  • Research Centers of America

    Hollywood, Florida, 33024

  • Clinical Trials of Florida, LLC

    Miami, Florida, 33186

  • Pacific Research Network

    San Diego, California, 92103

  • GNP Research

    Valdosta, Georgia, 31605

  • Clinical Site Partners Orlando, LLC

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Crossover Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Subjects With Moderate to Severe Obstructive Sleep Apnea and Adult and Elderly Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to [>=] 45 to less than [<] 65 years; elderly >=65 to 90 years) with moderate to severe obstructive sleep apnea (OSA) compared with placebo, and using pulse oximetry determine whether lemborexant decreases the peripheral oxygen saturation (SpO2) during total sleep time (TST) on Day 8 of treatment in adult and elderly participants (adults >=45 to <65 years; elderly >=65 to 90 years) with moderate to severe chronic obstructive pulmonary disease (COPD) compared with placebo.

Being tested
Placebo, Lemborexant 10 mg
Keywords
E2006, Lemborexant, Peripheral Oxygen Saturation, Apnea Hypopnea Index
Medical subject headings
Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Respiration Disorders

What participants receive

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

  • PlaceboDrug

    Also called E2006

    OSA: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

  • Lemborexant 10 mgDrug

    Also called E2006

    OSA: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

  • PlaceboDrug

    Also called E2006

    COPD: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

  • Lemborexant 10 mgDrug

    Also called E2006

    COPD: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.

Study groups in NCT04647383
Study groupRoleWhat they receive
OSA Cohort, Sequence A: Placebo + Lemborexant 10 mgExperimentalParticipants with OSA will receive one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days will be maintained between the 2 treatment periods.
Receives: Drug: Placebo; Drug: Lemborexant 10 mg
OSA Cohort, Sequence B: Lemborexant 10 mg + PlaceboExperimentalParticipants with OSA will receive one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days will be maintained between the 2 treatment periods.
Receives: Drug: Placebo; Drug: Lemborexant 10 mg
COPD Cohort, Sequence C: Placebo + Lemborexant 10 mgExperimentalParticipants with COPD will receive one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days will be maintained between the 2 treatment periods.
Receives: Drug: Placebo; Drug: Lemborexant 10 mg
COPD Cohort, Sequence D: Lemborexant 10 mg + PlaceboExperimentalParticipants with COPD will receive one lemborexant 10 mg tablet on the night of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet on the night of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days will be maintained between the 2 treatment periods.
Receives: Drug: Placebo; Drug: Lemborexant 10 mg

What is being measured

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

  1. OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2

    AHI was the number of apneas and hypopneas divided by the total sleep time (TST) (in minutes) and multiplied by 60 (minute per hour [min/hour]) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI greater than or equal to (>=) 5 to less than (<) 15 is classed as mild, AHI >=15 to <30 as moderate, and AHI >=30 as severe. TST was defined as the total time asleep in minutes using polysomnography (PSG).

    Measured: Day 8 of Treatment Periods 1 and 2 (up to Day 30)

  2. COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2

    SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.

    Measured: Day 8 of Treatment Periods 1 and 2 (up to Day 30)

Secondary outcomes (10)

  1. OSA Cohort: AHI on Day 1 of Treatment Periods 1 and 2

    AHI was the number of apneas and hypopneas divided by the TST (in minutes) and multiplied by 60 (min/hour) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI >=5 to <15 is classed as mild, >=15 to <30 as moderate, and AHI >=30 as severe. TST was defined as the total time asleep in minutes using PSG.

    Measured: Day 1 of Treatment Periods 1 and 2 (up to Day 23)

  2. OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2

    SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.

    Measured: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  3. OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2

    TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

    Measured: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  4. OSA Cohort: Mean Oxygen Desaturation Index (ODI) on Days 1 and 8 of Treatment Periods 1 and 2

    ODI was defined as (oxygen desaturations >=3%*60)/TST (that is, the average number of oxygen desaturations >=3% per hour of sleep), as defined by the American Academy of Sleep Medicine. TST was defined as the total time asleep in minutes using PSG.

    Measured: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  5. OSA Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2

    Desaturation was defined as decrease in the mean SpO2 of >=3% (over the last 120 seconds) that lasts for at least 10 seconds. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

    Measured: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  6. COPD Cohort: Peripheral SpO2 During TST on Day 1 of Treatment Periods 1 and 2

    SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.

    Measured: Day 1 of Treatment Periods 1 and 2 (up to Day 23)

  7. COPD Cohort: AHI on Days 1 and 8 of Treatment Periods 1 and 2

    AHI was the number of apneas and hypopneas divided by the TST (in minutes) and multiplied by 60 (min/hour) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI >=5 to <15 is classed as mild, >=15 to <30 as moderate, and AHI >=30 as severe. TST was defined as the total time asleep in minutes using PSG.

    Measured: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  8. COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2

    TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

    Measured: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  9. COPD Cohort: Mean ODI on Days 1 and 8 of Treatment Periods 1 and 2

    ODI was defined as (oxygen desaturations >=3%*60)/TST (that is, the average number of oxygen desaturations >=3% per hour of sleep), as defined by the American Academy of Sleep Medicine. TST was defined as the total time asleep in minutes using PSG.

    Measured: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

  10. COPD Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2

    Desaturation was defined as decrease in the mean SpO2 of >=3% (over the last 120 seconds) that lasts for at least 10 seconds. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.

    Measured: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)

Timeline

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

  1. First posted30 Nov 2020
  2. Study start6 Jan 2021
  3. Primary completion10 Feb 2022
  4. Study completion10 Feb 2022

Resources

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
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04647383
Sponsor's protocol ID
E2006-A001-113
Status last verified
Feb 2022
First submitted
26 Nov 2020
Last updated
10 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Publications

  • Khullar A, Boulos MI, Mak MSB, Moline M, Cheng JY, Hall N. Effect of lemborexant on sleep parameters and architecture in adult and elderly participants with mild-to-severe obstructive sleep apnea. Sleep Med. 2025 Oct;134:106757. doi: 10.1016/j.sleep.2025.106757. Epub 2025 Aug 18.

    PubMed 40848323

  • Cheng JY, Lorch D, Hall N, Moline M. Respiratory safety of lemborexant in adult and elderly subjects with moderate-to-severe chronic obstructive pulmonary disease. J Sleep Res. 2025 Apr;34(2):e14334. doi: 10.1111/jsr.14334. Epub 2024 Sep 12.

    PubMed 39266012

  • Cheng JY, Lorch D, Lowe AD, Uchimura N, Hall N, Shah D, Moline M. A randomized, double-blind, placebo-controlled, crossover study of respiratory safety of lemborexant in moderate to severe obstructive sleep apnea. J Clin Sleep Med. 2024 Jan 1;20(1):57-65. doi: 10.5664/jcsm.10788.

    PubMed 37677076

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lemborexant 10 mg in people with Sleep Apnea, Obstructive and Pulmonary Disease, Chronic Obstructive, run by Eisai Inc. at 11 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 23 inclusion and 45 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 10 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 11 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 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 10 Oct 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?

OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2 (time frame: Day 8 of Treatment Periods 1 and 2 (up to Day 30)). 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?

On the ClinicalTrials.gov record for NCT04647383, 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 10 Oct 2023.

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