Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742699
Status:
COMPLETED
Last Update Posted:
2023-03-15
First Post:
2021-02-03
Brief Title:
An Open-label Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia
Sponsor:
Kurume University
Organization:
Kurume University
Study Overview
Official Title:
An Open-label Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia
Status:
COMPLETED
Status Verified Date:
2023-03
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:
This study will be conducted to evaluate whether the approach of direct transitioning to lemborexant LEM is supported for insomnia patients who are unsatisfied with current medication
Transition from Following 4 regimens of interest will be investigated Z-Drug monotherapy suvorexant SUV monotherapy SUV and benzodiazepine receptor agonists BZRA combination therapy and ramelteon RMT and BZRA combination therapy Patients with insomnia who have been treated with one of the regimens but do not have treatment satisfaction will be enrolled
As a comprehensive indicator of patient satisfaction including treatment efficacy and safety the proportion of patients with successful transitioning will be evaluated at 2 weeks after transitioning thus important initial response after transitioning will be evaluated as a primary endpoint In addition as a secondary purpose the treatment continuation efficacy and tolerability and the treatment impression for insomnia Patient Global Impression of Insomnia for 14 weeks after transitioning will be assessed
Transition from Following 4 regimens of interest will be investigated Z-Drug monotherapy suvorexant SUV monotherapy SUV and benzodiazepine receptor agonists BZRA combination therapy and ramelteon RMT and BZRA combination therapy Patients with insomnia who have been treated with one of the regimens but do not have treatment satisfaction will be enrolled
As a comprehensive indicator of patient satisfaction including treatment efficacy and safety the proportion of patients with successful transitioning will be evaluated at 2 weeks after transitioning thus important initial response after transitioning will be evaluated as a primary endpoint In addition as a secondary purpose the treatment continuation efficacy and tolerability and the treatment impression for insomnia Patient Global Impression of Insomnia for 14 weeks after transitioning will be assessed
Detailed Description:
None
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