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New treatment option for Excessive Sleepiness
Official title Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
ClinicalTrials.gov ID: NCT06568367
What this study is testing
What is Solriamfetol 150 mg?
Solriamfetol 150 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for excessive sleepiness.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Meets International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD)
- Provides written informed consent to participate in the study before the conduct of any study procedures.
- Male or female, aged 18 to 65 inclusive.
You likely can't join if
- Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
- Unable to comply with study procedures.
- Medically inappropriate for study participation in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Cullman, Alabama, United States
- Chandler, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Cerritos, California, United States
- Chula Vista, California, United States
- Huntington Beach, California, United States
- Long Beach, California, United States
- Santa Ana, California, United States
- Colorado Springs, Colorado, United States
- Brandon, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Atlanta, Georgia, United States
- Stockbridge, Georgia, United States
- Towson, Maryland, United States
- Boston, Massachusetts, United States
- Lansing, Michigan, United States
- Novi, Michigan, United States
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cullman, Alabama, United States; Chandler, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Cerritos, California, United States; Chula Vista, California, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.