UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054075 |
|---|---|
| Receipt number | R000061746 |
| Scientific Title | Use of Lemborexant for Insomnia in Our Clinic: A Retrospective Study |
| Date of disclosure of the study information | 2024/04/06 |
| Last modified on | 2026/01/13 13:28:46 |
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Basic information
Public title
Use of Lemborexant for Insomnia in Our Clinic: A Retrospective Study
Acronym
Use of Lemborexant for Insomnia in Our Clinic: A Retrospective Study
Scientific Title
Use of Lemborexant for Insomnia in Our Clinic: A Retrospective Study
Scientific Title:Acronym
Use of Lemborexant for Insomnia in Our Clinic: A Retrospective Study
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy and side effects of Lemborexant in patients with insomnia, primarily focusing on younger individuals, utilizing a large sample size. While previous research has demonstrated that Lemborexant improves sleep quality and reduces sleep onset time with relatively few side effects, the effects and side effects of long-term use necessitate further examination with a larger cohort. Furthermore, there are few studies that have investigated the long-term effects and side effects of Lemborexant in younger populations. This research aims to provide new scientific evidence for the treatment of insomnia by comprehensively assessing the efficacy and side effects of Lemborexant in patients with insomnia, with a particular focus on younger individuals, through a large-scale sample size.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study evaluates the impact of Lemborexant treatment on patients' sleep latency, number of nocturnal awakenings, frequency of early morning awakenings, and sleep quality. Additionally, the efficacy of Lemborexant will be assessed using the Athens Insomnia Scale (AIS).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who visited our clinic between April 2022 and March 2024
2.Patients diagnosed with insomnia and prescribed Lemborexant at their initial visit
3.Patients with no history of Lemborexant use prior to their first consultation
4.Adult patients aged 18 years and older
Key exclusion criteria
1.Patients diagnosed with sleep disorders other than insomnia
2.Patients who were administered other insomnia medications or had their Lemborexant dosage changed within 4 weeks from the initial consultation
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Rui |
| Middle name | |
| Last name | Hioki |
Organization
Wellness General Clinic
Division name
Wellness General Clinic
Zip code
550013
Address
Yukinari building 7F, 1-8-1, Shinmachi, Nishi-ku, Osaka-Shi, Osaka
TEL
0666848552
info@wellness-general.jp
Public contact
Name of contact person
| 1st name | Hinako |
| Middle name | |
| Last name | Imamura |
Organization
Wellness General Clinic
Division name
Wellness General Clinic
Zip code
550013
Address
Yukinari building 7F, 1-8-1, Shinmachi, Nishi-ku, Osaka-Shi, Osaka
TEL
0666848552
Homepage URL
info@wellness-general.jp
Sponsor or person
Institute
Wellness General Clinic
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University Institutional Review Board
Address
Abeno Medics 6F, 1-2-7, Asahi-cho, Abeno-ku, Osaka-shi, Osaka
Tel
06-6645-3456
gr-a-knky-ethics@omu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
382
Results
AIS total score improved from 11.9 at the first visit to 5.9 at the final follow up. All eight subitems also decreased significantly after Holm-Bonferroni correction.
A linear mixed-effects model with random intercepts revealed a significant main effect of Time.
Proportion achieving AIS under 5 rose from 7.6 % at the first visit to 50.3 % at final follow up.
Results date posted
| 2026 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All included patients had at least one online consultation during the observation period. Furthermore, there were no significant differences in baseline characteristics between the patients included in the analysis and the 67 patients who were excluded due to dosage adjustments within four weeks (dose-adjusted group). Of the 382 participants, 267 (69.9%) completed three or more AIS assessments. There were no significant differences in baseline characteristics between the two-visit group and the three-or-more-visit group. The number of patients was 382 (male/female = 189/193). The mean subject age was 34.3 years. The mean lemborexant dosage during the observation period was 5.8 mg. The mean observation period for all participants was 216.6 days, with an average interval of 30.7 days until the second visit. The median observation period was 95 days. The most frequent psychiatric comorbidities were depression (6.8 %) and adjustment disorder (5.8 %).
Participant flow
Eight-hundred forty-three patients aged 18 years or older were prescribed lemborexant on their first visit during the observation period. Among them, 394 patients were prescribed hypnotics other than lemborexant during the observation period, while 449 patients were prescribed lemborexant exclusively. Of these, 67 patients had their lemborexant dosage adjusted within 4 weeks of the first visit. Ultimately, 382 patients were included in the analysis.
Adverse events
Overall, 83 participants (21.7 %) reported at least one mild, transient adverse event. Most commonly somnolence (15.4 %) and headache (6.0 %). No physician-recorded treatment discontinuations due to adverse events occurred.
Outcome measures
Primary Outcome: Athens Insomnia Scale (AIS)
Secondary Outcomes: Age, sex, adverse events, medical history, and prescribed dosage
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to provide new scientific evidence for the treatment of insomnia by comprehensively evaluating the effects and side effects of Lemborexant in patients with insomnia, primarily among younger individuals, utilizing a large sample size. It will investigate the impact of Lemborexant treatment on reducing sleep latency, decreasing the number of nocturnal awakenings, lowering the frequency of early morning awakenings, and overall improvement in sleep quality through a large-scale sample size. Additionally, a detailed analysis of side effects will elucidate the safety profile of Lemborexant.
Data will be extracted using a Data Warehouse (DWH) from clinical records and consultation information such as those from Wellness Comprehensive Clinic.
Using the data collected with the aforementioned method, the following statistical analyses will be conducted:
Patient baseline information: age, gender, diagnosis, medical history, medication history, occupation, height, weight
Consultation outcomes: Athens Insomnia Scale (AIS), side effects
Prescription: prescribed medications and dosages
Management information
Registered date
| 2024 | Year | 04 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061746
