Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-27 @ 12:36 PM
Study NCT ID:
NCT06568367
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2024-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Sponsor:
Axsome Therapeutics, Inc.
Organization:
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:
2025-11
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:
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 1:1:1 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:
False
Is a FDA Regulated Drug?:
True
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?: