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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA Cohort, Sequence A: Placebo + Lemborexant 10 mg | Experimental | Participants 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. |
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| OSA Cohort, Sequence B: Lemborexant 10 mg + Placebo | Experimental | Participants 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. |
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| COPD Cohort, Sequence C: Placebo + Lemborexant 10 mg | Experimental | Participants 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. |
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| COPD Cohort, Sequence D: Lemborexant 10 mg + Placebo | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 8 of Treatment Periods 1 and 2 (up to Day 30) |
| 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. | Day 8 of Treatment Periods 1 and 2 (up to Day 30) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
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:
Moderate to severe COPD according to medical history and screening spirometry as per the GOLD criteria (GOLD 2019)
On screening PSG
Exclusion Criteria:
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:
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):
On screening PSG (COPD only):
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Glendale | Arizona | 85306 | United States | ||
| Pacific Research Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40848323 | Derived | 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. | |
| 39266012 | Derived | 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. |
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Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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A total of 48 participants for the obstructive sleep apnea (OSA) cohort were screened, of which 15 were screen failures and 33 were randomized in OSA cohort to receive study treatment. A total of 108 participants were screened for the chronic obstructive pulmonary disease (COPD) cohort, of which 78 were screen failures and 30 were randomized in COPD cohort to receive study treatment.
Participants took part in the study at 10 investigative sites in the United States from 06 January 2021 to 10 February 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | OSA Cohort, Sequence A: Placebo + Lemborexant 10 mg | Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant 10 milligram (mg) tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 (8 Days) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2020 | Dec 10, 2022 |
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| Lemborexant 10 mg | Drug | 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. |
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| Placebo | Drug | 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. |
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| Lemborexant 10 mg | Drug | 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. |
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| Day 1 of Treatment Periods 1 and 2 (up to Day 23) |
| 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. | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
| 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. | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
| 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. | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
| 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. | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
| 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. | Day 1 of Treatment Periods 1 and 2 (up to Day 23) |
| 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. | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
| 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. | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
| 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. | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
| 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. | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
| San Diego |
| California |
| 92103 |
| United States |
| Teradan Clinical Trials | Brandon | Florida | 33511 | United States |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| Clinical Trials of Florida, LLC | Miami | Florida | 33186 | United States |
| Clinical Site Partners Orlando, LLC | Winter Park | Florida | 32789 | United States |
| NeuroTrials Research Inc. | Atlanta | Georgia | 30328 | United States |
| GNP Research | Valdosta | Georgia | 31605 | United States |
| CTI Clinical Trial & Consulting Services | Cincinnati | Ohio | 45212 | United States |
| Intrepid Research, LLC | Cincinnati | Ohio | 45245 | United States |
| 37677076 | Derived | 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. |
| FG001 | OSA Cohort, Sequence B: Lemborexant 10 mg + Placebo | Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods. |
| FG002 | COPD Cohort, Sequence C: Placebo + Lemborexant 10 mg | Participants with COPD received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods. |
| FG003 | COPD Cohort, Sequence D: Lemborexant 10 mg + Placebo | Participants with COPD received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods. |
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| Washout Period (14 Days) |
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| Treatment Period 2 (8 Days) |
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The safety analysis set for each cohort was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | OSA Cohort, Sequence A: Placebo + Lemborexant 10 mg | Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods. |
| BG001 | OSA Cohort, Sequence B: Lemborexant 10 mg + Placebo | Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by one lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods. |
| BG002 | COPD Cohort, Sequence C: Placebo + Lemborexant 10 mg | Participants with COPD received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods. |
| BG003 | COPD Cohort, Sequence D: Lemborexant 10 mg + Placebo | Participants with COPD received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 1, followed by lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Period 2. A washout period of 14 days was maintained between both treatment periods. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | 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). | The pharmacodynamic (PD) analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | events (apnea plus hyponea) per hour | Day 8 of Treatment Periods 1 and 2 (up to Day 30) |
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| Primary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Day 8 of Treatment Periods 1 and 2 (up to Day 30) |
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| Secondary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Mean | Standard Deviation | events (apnea plus hyponea) per hour | Day 1 of Treatment Periods 1 and 2 (up to Day 23) |
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| Secondary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, "number analyzed" signifies those participants who were evaluable at given timepoint for this outcome measure. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
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| Secondary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, "number analyzed" signifies those participants who were evaluable at given timepoint for this outcome measure. | Posted | Mean | Standard Deviation | percentage of TST | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
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| Secondary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, "number analyzed" signifies those participants who were evaluable at given timepoint for this outcome measure. | Posted | Mean | Standard Deviation | events per hour | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
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| Secondary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, "number analyzed" signifies those participants who were evaluable at given timepoint for this outcome measure. | Posted | Mean | Standard Deviation | events (number of desaturations) | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
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| Secondary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Mean | Standard Deviation | percentage of oxygen saturation | Day 1 of Treatment Periods 1 and 2 (up to Day 23) |
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| Secondary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Mean | Standard Deviation | events (apnea plus hyponea) per hour | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
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| Secondary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Mean | Standard Deviation | percentage of TST | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
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| Secondary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Mean | Standard Deviation | events per hour | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
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| Secondary | 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. | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | Posted | Mean | Standard Deviation | events (number of desaturations) | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) |
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Baseline up to end of follow up visit (up to 59 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OSA Cohort: Placebo | Participants with OSA received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods. | 0 | 33 | 1 | 33 | 0 | 33 |
| EG001 | OSA Cohort: Lemborexant 10 mg | Participants with OSA received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods. | 0 | 33 | 0 | 33 | 2 | 33 |
| EG002 | COPD Cohort: Placebo | Participants with COPD received lemborexant-matched placebo tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods. | 0 | 30 | 0 | 30 | 2 | 30 |
| EG003 | COPD Cohort: Lemborexant 10 mg | Participants with COPD received lemborexant 10 mg tablet, orally, once daily on the night (within 5 minutes of lights off) of Day 1 through Day 8 of Treatment Periods 1 and 2. A washout period of 14 days was maintained between both treatment periods. | 0 | 30 | 1 | 30 | 1 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SARS-CoV-2 test positive | Investigations | MedDRA Version 24.1 | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Ulna fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Information | Eisai Inc. | +1-888-274-2378 | esi_medinfo@eisai.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 19, 2020 | Dec 10, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000634104 | lemborexant |
Not provided
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Japanese |
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| Native Hawaiian or Other Pacific Islander |
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