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NCT06568367 · ClinicalTrials.gov registry record · Phase 3
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
A Phase 3 study of Shift-work Disorder and Excessive Sleepiness, sponsored by Axsome Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 520
- Enrollment target
- 20
- Study locations
NCT06568367: Recruiting Phase 3 study of Shift-work Disorder and Excessive Sleepiness, sponsored by Axsome Therapeutics.
NCT06568367 is a Phase 3 study of Shift-work Disorder and Excessive Sleepiness that is actively recruiting participants, run by Axsome Therapeutics. The registered enrollment target is 520 participants, above the 84-participant average among 3 other Shift-work Disorder trials with a reported enrollment target (519% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06568367, a Phase 3 study of Shift-work Disorder and Excessive Sleepiness, is actively recruiting participants, sponsored by Axsome Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 520 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Solriamfetol 150 mg
- DRUG Solriamfetol 300 mg
Study Locations (20)
Florida
- Clinical Research Site - Brandon
- Clinical Research Site - Hialeah
- Clinical Research Site - Miami
- Clinical Research Site - Miami
- Clinical Research Site - Miami
- Clinical Research Site - Miami Lakes
California
- Clinical Research Site - Cerritos
- Clinical Research Site - Chula Vista
- Clinical Research Site - Huntington Beach
- Clinical Research Site - Long Beach
- Clinical Research Site - Santa Ana
Arizona
- Clinical Research Site - Chandler
- Clinical Research Site - Tucson
Georgia
- Clinical Research Site - Atlanta
- Clinical Research Site - Stockbridge
Alabama
- Clinical Research Site - Cullman
Arkansas
- Clinical Research Site - Little Rock
Colorado
- Clinical Research Site - Colorado Springs
Maryland
- Clinical Research Site - Towson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 520 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What NCT06568367 shows while recruiting
NCT06568367 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, above the 84-participant average among 3 other Shift-work Disorder trials with a reported enrollment target (519% higher).
The record links to 2 conditions, with Shift-work Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06568367 names 20 study sites across 9 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06568367 about?
NCT06568367 is a clinical study titled "Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)". 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 w...
What is the current status of trial NCT06568367?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 520 participants. The study started on 2024-08-01. Estimated completion is 2026-12.
What conditions does trial NCT06568367 study?
This clinical trial studies the following conditions: Shift-work Disorder, Excessive Sleepiness.
What interventions are being tested in trial NCT06568367?
The interventions under investigation include: Placebo (DRUG), Solriamfetol 150 mg (DRUG), Solriamfetol 300 mg (DRUG).
Who is sponsoring clinical trial NCT06568367?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06568367 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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