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Phase 1 Completed N=63 Randomized Double-blind Treatment

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

Sleep Apnea, Obstructive · Pulmonary Disease, Chronic Obstructive · Respiration Disorders
Source: ClinicalTrials.gov NCT04647383 ↗
Enrolled (actual)
63
Serious AEs
1.6%
Results posted
Oct 2023
Primary outcomePrimary: OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2 — 45.09; 44.90 events (apnea plus hyponea) per hour

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 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 to 90 years) with moderate to severe chronic obstructive pulmonary disease (COPD) compared with placebo.

Outcome Measures

OutcomeResultp-value
PRIMARY
OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2
45.09; 44.90
PRIMARY
COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2
90.80; 91.27
SECONDARY
OSA Cohort: AHI on Day 1 of Treatment Periods 1 and 2
44.65; 41.64
SECONDARY
OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2
93.12; 93.00; 93.44; 93.06
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
11.966; 12.849; 2.708; 3.748; 0.776; 1.125
SECONDARY
OSA Cohort: Mean Oxygen Desaturation Index (ODI) on Days 1 and 8 of Treatment Periods 1 and 2
39.71; 36.52; 39.07; 39.51
SECONDARY
OSA Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2
253.85; 256.52; 255.28; 273.97
SECONDARY
COPD Cohort: Peripheral SpO2 During TST on Day 1 of Treatment Periods 1 and 2
91.53; 91.13
SECONDARY
COPD Cohort: AHI on Days 1 and 8 of Treatment Periods 1 and 2
6.09; 7.40; 5.88; 6.15
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
15.593; 21.468; 0.860; 3.286; 0.155; 0.224
SECONDARY
COPD Cohort: Mean ODI on Days 1 and 8 of Treatment Periods 1 and 2
4.61; 5.46; 4.34; 4.71
SECONDARY
COPD Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2
26.77; 36.07; 25.33; 29.97

Eligibility Criteria

Inclusion Criteria

  • Male or female, age >=45 and =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) 90% (both supine and sitting)
  • SpO2 during sleep >=80% for at least 75% of the recording period with no more than five continuous minutes =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 =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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04647383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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