Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia

Insomnia Clinical Trial

— PROEM  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06225947
• Other study ID #: KY2023-1072-02
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Guangdong Provincial People's Hospital
• Contact: Xueli Li, Master
• Phone: 15876549787
• Email: lixueli[@]gdph.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
China	Clifford Hospital	Guangzhou	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Guangzhou United Family Hospital	Guangzhou	Guangdong
China	Nanfang Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital	Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of Serious Adverse Events during LEM treatment	Percentage of Participants Reporting one or More Serious Adverse Events (SAEs)	Up to week 12