Ignite Creation Date:
2024-05-06 @ 8:51 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02841709
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2016-07-20
Brief Title:
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Multi-center Double-blind Randomized Placebo-controlled 5-period 5-treatment Crossover Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Status:
COMPLETED
Status Verified Date:
2020-04
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 evaluates the dose response of ACT-541468 on the change of wake after sleep onset WASO assessed by polysomnography PSG on the first 2 days of each treatment period
Detailed Description:
The study consists of 3 phases a screening phase a double-blind treatment phase consisting of 5 periods and a safety follow-up phase Safety is monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None