Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia (PROEM)

A Prospective, Multi-center, 3-month, Observational Study to Evaluate the Effectiveness and Safety of Lemborexant in Chinese Patients With Insomnia in Real World Setting.

This study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(LEM). Patient self-evaluation reports and safety events will be collected at baseline and 4 visits during treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Drug: Lemborexant 5 MG

Detailed Description

This study is a prospective, open-label, single arm, multicenter study lasting 12 weeks to evaluate effectiveness and safety of lemborexant(LEM). Adult patients diagnosed with insomnia (including chronic and short-term insomnia) in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and ISI ≥10, clinically judged to need pharmacological treatment will be enrolled.Patients will be administered with LEM, and patient self-evaluation reports and safety events will be collected at baseline and each visit during treatment.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Xueli Li, Master; Phone Number: 15876549787; Email: lixueli@gdph.org.cn
• Study Contact Backup: Name: Shuqiong Zheng, Master; Phone Number: 13192676969; Email: 844349307@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital
      • Principal Investigator: Bin Zhang, MD
      • Contact: Shuqiong Zheng, Master; Phone Number: 13192676969; Email: 844349307@qq.com
      • Sub-Investigator: Ting Xu, MD
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Provincial People's Hospital
      • Contact: Xueli Li, Master; Phone Number: 15876549787; Email: lixueli@gdph.org.cn
      • Principal Investigator: Fujun Jia, MD
      • Sub-Investigator: Xueli Li, Master
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital
      • Contact: Yin Chen, MD; Phone Number: 1357088851; Email: cheny_sysu@163.com
      • Principal Investigator: Yamei Tang, MD
      • Sub-Investigator: Yin Chen, MD
    • Guangzhou, Guangdong, China, 510335
      • Guangzhou United Family Hospital
      • Contact: Jin Li, PHD; Phone Number: 13824492310; Email: li.jin@ufh.com.cn
      • Principal Investigator: Weiyin Jian, Bachelor
      • Sub-Investigator: Jin Li, PHD
    • Guangzhou, Guangdong, China, 511400
      • Clifford Hospital
      • Contact: Qian Wu, Bachelor; Phone Number: 13760787879; Email: 837964094@qq.com
      • Principal Investigator: Yongqiang Lin, Bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chinese patients with insomnia administered with LEM.

Description

Inclusion Criteria:

• Adults (≥18 years) and agreed to participate in the study, regardless of gender.
• Diagnosed with insomnia according to DSM-5.
• Insomnia Severity Index (ISI) score >10.
• Subjects who can guarantee at least 7 hours of bedtime.

Exclusion Criteria:

• Beings unable to understand the questionnaire.
• PHQ-9 scores ≥ 20.
• GAD-7 scores ≥ 15.
• Suicidal thoughts/behaviors in the past one month or history of suicide, etc.
• Severe psychiatric disorder in the judgment of the investigator prevents completion of the trial.
• History of serious illness, mental illness, medication use, and uncontrolled poor sleep habits that the investigator believes interfere with the study evaluation or the safety of the subject.
• According to the precautions listed in the instructions, there are any contraindications or other conditions for which the use is prohibited (such as narcolepsy, severe liver damage, pregnant, nursing or pregnant women, etc.).
• Other conditions not considered appropriate for participation by clinicians.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lemborexant(LEM); Subjects will be administered with Lemborexant(LEM). The dosage of LEM is 5 mg or 10mg taken no more than once per night during the study.	Drug: Lemborexant 5 MG; The recommended dosage of Lemborexant(LEM) is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability.; Other Names: DAYVIGO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with insomnia remission	Percentage of patients with total ISI score below 8 points after Lemborexant treatment. Insomnia remission is defined as total ISI below 8points. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity.	Baseline, week 1, week 2, week 4, week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate of Lemborexant treatment at each visit	The retention rate is defined as the percentage of participants remaining on Lemborexant treatment regardless of treatment pattern, starting from the first dose of study drug. The retention is primarily defined as follows: Patients who wish to continue LEM treatment at each visit.; Patients who wish to continue LEM treatment at each visit. but do not actually continue with a reason not related to the efficacy or safety of LEM treatment (including, but not limited to relocation, clinic transfer, or a burden of site visit expenses)	up to week 12
Change from baseline of mean ISI score at each visit	Change of mean ISI score from baseline was defined as the average score of ISI scale at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity.	Baseline, week 1, week 2, week 4, week 12
Change from baseline of mean ISI score at LEM 5mg and 10 mg at each visit	Change of mean ISI score from baseline was defined as the average score of ISI scale at LEM 5mg and LEM 10mg at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity.	Baseline, week 1, week 2, week 4, week 12
Change from baseline of mean ISI score at age <55 and ≥ 55 at each visit	Change of mean ISI score from baseline was defined as the average score of ISI scale at age <55 and ≥ 55 at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity.	Baseline, week 1, week 2, week 4, week 12
Change from baseline of mean ISI score with LEM monotherapy, alternative therapy, and combination therapy at each visit	Change of mean ISI score from baseline was defined as the average score of ISI scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.; LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy.; Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM.; Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity.	Baseline, week 1, week 2, week 4, week 12
Change from baseline of mean ISI score in patients with depression symptoms at each visit	Change of mean ISI score from baseline was defined as the average score of ISI scale in patients with depression symptoms at each visit relative to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.	Baseline, week 1, week 2, week 4, week 12
Proportion of insomnia treatment responders at each visit	Responder was defined as total ISI reduction≥6 compared to baseline. The ISI is a 7-item self-report questionnaire assessing the nature, severity and impact of insomnia. A 5-point likert scale is used to rate each item, score range=0 ~28. Higher score indicate worse severity.	Baseline, week 4, week 12
Changes of mean ESS score at each visit	Change of mean ESS score from baseline was defined as the average score of ESS scale at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness.	Baseline, week 1, week 2, week 4, week 12
Changes of mean ESS score at LEM 5mg and 10mg at each visit	Change of mean ESS score from baseline was defined as the average score of ESS scale at LEM 5mg and 10 mg at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness.	Baseline, week 1, week 2, week 4, week 12
Changes of mean ESS score at age <55 and ≥ 55 at each visit	Change of mean ESS score from baseline was defined as the average score of ESS scale at age <55 and ≥ 55 at each visit relative to baseline.The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness.	Baseline, week 1, week 2, week 4, week 12
Changes of mean ESS score with LEM monotherapy, alternative therapy, and combination therapy at each visit	Change of mean ESS score from baseline was defined as the average score of ESS scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.; LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy.; Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM.; Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics. The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness.	Baseline, week 1, week 2, week 4, week 12
Changes of mean QOL-BREF score at each visit	Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life.	Baseline, week 4, week 12
Changes of mean QOL-BREF score at LEM 5mg and 10mg at each visit	Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale at LEM 5mg and 10mg at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life.	Baseline, week 4, week 12
Changes of mean QOL-BREF score at age <55 and ≥ 55 at each visit	Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale at age <55 and ≥ 55 at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life.	Baseline, week 4, week 12
Changes of mean QOL-BREF score with LEM monotherapy, alternative therapy, and combination therapy at each visit	Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.; LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy.; Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM.; Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life.	Baseline, week 4, week 12
Changes of mean QOL-BREF score in patients with depression symptoms at each visit	Change of mean QOL-BREF score from baseline was defined as the average score of QOL-BREF scale in patients with depression symptoms at each visit relative to baseline. QOL-BREF is used 26-items WHOQOL-BREF assessing quality of life. A 5-point likert scale is used to rate each item, score range=0-100. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.	Baseline, week 4, week 12
Changes of mean PHQ-9 score at each visit	Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale at each visit relative to baseline. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.	Baseline, week 1, week 2, week 4, week 12
Changes of mean PHQ-9 score at LEM 5mg and 10mg at each visit	Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale at LEM 5mg and 10mg at each visit relative to baseline. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.	Baseline, week 1, week 2, week 4, week 12
Changes of mean PHQ-9 score at age <55 and ≥ 55 at each visit	Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale at age <55 and ≥ 55 at each visit relative to baseline. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.	Baseline, week 1, week 2, week 4, week 12
Changes of mean PHQ-9 score with LEM monotherapy, alternative therapy, and combination therapy at each visit	Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.; LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy.; Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM.; Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.	Baseline, week 1, week 2, week 4, week 12
Changes of mean PHQ-9 score in patients with depression symptoms at each visit	Change of mean PHQ-9 score from baseline was defined as the average score of PHQ-9 scale in patients with depression symptoms at each visit relative to baseline. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10.The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.	Baseline, week 1, week 2, week 4, week 12
Changes of mean GAD-7 score at each visit	Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety.	Baseline, week 1, week 2, week 4, week 12
Changes of mean GAD-7 score at LEM 5mg and 10mg at each visit	Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale at LEM 5mg and 10mg at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety.	Baseline, week 1, week 2, week 4, week 12
Changes of mean GAD-7 score at age <55 and ≥ 55 at each visit	Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale at age <55 and ≥ 55 at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety.	Baseline, week 1, week 2, week 4, week 12
Changes of mean GAD-7 score with LEM monotherapy, alternative therapy, and combination therapy at each visit	Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale with LEM monotherapy, alternative therapy, and combination therapy at each visit relative to baseline.; LEM monotherapy is defined as participant who has not previously taken hypnotics(e.g. benzodiazepine receptor agonists, sedative antidepressants, etc.) and initiated of LEM monotherapy.; Alternative therapy is defined as participant who discontinued benzodiazepine hypnotics with initiation of LEM.; Combination therapy is defined as participant who add LEM to the current medication of benzodiazepine hypnotics. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety.	Baseline, week 1, week 2, week 4, week 12
Changes of mean GAD-7 score in patients with depression symptoms at each visit	Change of mean GAD-7 score from baseline was defined as the average score of GAD-7 scale in patients with depression symptoms at each visit relative to baseline. The GAD-7 is a 7-items self-reported questionnaire assessing anxiety disorder severity. A 4-point likert scale is used to rate each item, score range=0-21, with higher scores indicating greater severity of anxiety. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.	Baseline, week 1, week 2, week 4, week 12
Changes of mean ESS score in patients with depression symptoms at each visit	Change of mean ESS score from baseline was defined as the average score of ESS scale in patients with depression symptoms at each visit relative to baseline. The ESS is a 8-items self-report questionnaire assessing daytime sleepiness. A 4-point likert scale is used to rate each item, score range=0-24, with higher scores indicating greater daytime sleepiness. Patients with depression symptoms were defined as patients with PHQ-9 ≥ 10. The PHQ-9 is a 9-items self-report questionnaire assessing depression and severity. A 4-point likert scale is used to rate each item, score range=0-27, with higher scores indicating greater severity of depression.	Baseline, week 1, week 2, week 4, week 12
Incidence of Treatment-Emergent Adverse Events during LEM treatment	Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity	Up to week 12
Incidence of Serious Adverse Events during LEM treatment	Percentage of Participants Reporting one or More Serious Adverse Events (SAEs)	Up to week 12

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Fujun Jia, MD, Guangdong Provincial People's Hospital; Principal Investigator: Bin Zhang, MD, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: insomnia; lemborexant
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; Sleep Aids, Pharmaceutical; Orexin Receptor Antagonists; Lemborexant
• Other Study ID Numbers: KY2023-1072-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No