Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568367
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Studying Solriamfetol Modulation of TAAR-1 Dopamine and Norepinephrine in Shift Work Disorder SUSTAIN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-center Randomized Double-blind Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SUSTAIN Studying Solriamfetol Modulation of TAAR-1 Dopamine and Norepinephrine in Shift Work Disorder is a Phase 3 multi-center randomized double-blind placebo-controlled parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder SWD
Detailed Description:
Eligible subjects must meet the International Classification of Sleep Disorders Third Edition ICSD-3 criteria for Shift Work Disorder SWD Subjects will be randomized in a 111 ratio to receive solriamfetol titrated to either 150 mg 300 mg or placebo once per night shift for 12 weeks
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