Patient-Reported Outcomes for Lemborexant in Chinese Participants With Insomnia

NCT06225947 | Recruiting DMC

• 1 other identifier: KY2023-1072-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Insomnia

Keywords

insomnia; lemborexant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• Retention rate of Lemborexant treatment at each visit

  up to week 12

• Change from baseline of mean ISI score at each visit

  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

  Baseline, week 1, week 2, week 4, week 12

• Change from baseline of mean ISI score at age <55 and ≥ 55 at each visit

  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

  Baseline, week 1, week 2, week 4, week 12

Study Arms (1)

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

Interventions

Lemborexant 5 MG DRUG

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.

Also known as: DAYVIGO

Lemborexant(LEM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese patients with insomnia administered with LEM.

You may qualify if:

• 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.
• Subjects signed informed consent forms after the prescription.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (5)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Guangzhou United Family Hospital

Guangzhou, Guangdong, 510335, China

RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

Clifford Hospital

Guangzhou, Guangdong, 511400, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Fujun Jia, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Bin Zhang, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueli Li, Master

CONTACT

15876549787; lixueli@gdph.org.cn

Shuqiong Zheng, Master

CONTACT

13192676969; 844349307@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: February 22, 2024
• Primary Completion: March 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)