Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02839200
Status:
COMPLETED
Last Update Posted:
2020-04-13
First Post:
2016-07-18
Brief Title:
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Multi-center Double-blind Randomized Placebo-controlled Active-reference Parallel-group Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Adult 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 WASO from baseline to Days 1 and 2 assessed by PSG
Detailed Description:
This study consists of the following phases screening phase double-blind treatment phase 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