Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04549168
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2020-09-09
Brief Title:
A Study of Lemborexant in Chinese Participants With Insomnia Disorder
Sponsor:
Eisai Co Ltd
Organization:
Eisai Inc
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Parallel-Group Phase 3 Study of the Efficacy and Safety of Lemborexant in Chinese Subjects With Insomnia Disorder
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to confirm using polysomnography PSG that lemborexant 10 milligram mg is superior to placebo on objective sleep onset as assessed by latency to persistent sleep LPS during the last 2 nights of 1 month of treatment in participants with insomnia disorder
Detailed Description:
The study will have 2 phases the Prerandomization Phase and the Randomization Phase The Prerandomization Phase will comprise 3 periods that will last up to a maximum of 35 days a Screening Period a Run-in Period and a Baseline Period The Randomization Phase will comprise a Treatment Period during which participants will be treated for 30 nights 1 month and a minimum 14-day Follow-up Period before an End of Study EOS Visit up to 54 days The total study duration for each participant on this study is 89 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None