Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Start Date
8/1/2024
Completion Date
12/1/2026
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.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Solriamfetol 150 mg
Solriamfetol 300 mg
Placebo
Conditions
Locations
Clinical Research Site
Auburn, Alabama 36832
United States
Clinical Research Site
Cullman, Alabama 35055
United States
Clinical Research Site
Chandler, Arizona 85224
United States
Clinical Research Site
Tucson, Arizona 85704
United States
Clinical Research Site
Little Rock, Arkansas 72211
United States
Clinical Research Site
Anaheim, California 92801
United States
Clinical Research Site
Cerritos, California 90703
United States
Clinical Research Site
Chula Vista, California 91910
United States
Clinical Research Site
Huntington Beach, California 92647
United States
Clinical Research Site
Long Beach, California 90805
United States
Clinical Research Site
Santa Ana, California 92705
United States
Clinical Research Site
Colorado Springs, Colorado 80918
United States
Clinical Research Site
Brandon, Florida 33511
United States
Clinical Research Site
Hialeah, Florida 33016
United States
Clinical Research Site
Miami, Florida 33135
United States
Clinical Research Site
Miami, Florida 33144
United States
Clinical Research Site
Miami, Florida 33176
United States
Clinical Research Site
Miami Lakes, Florida 33016
United States
Clinical Research Site
Atlanta, Georgia 30238
United States
Clinical Research Site
Stockbridge, Georgia 30281
United States
Clinical Research Site
Chicago, Illinois 60634
United States
Clinical Research Site
Kenner, Louisiana 70065
United States
Clinical Research Site
Towson, Maryland 21286
United States
Clinical Research Site
Boston, Massachusetts 02115
United States
Clinical Research Site
Lansing, Michigan 48911
United States
Clinical Research Site
Novi, Michigan 48377
United States
Clinical Research Site
Southfield, Michigan 48075
United States
Clinical Research Site
Chesterfield, Missouri 63017
United States
Clinical Research Site
St Louis, Missouri 63123
United States
Clinical Research Site
Henderson, Nevada 89052
United States
Clinical Research Site
Middletown, New Jersey 07748
United States
Clinical Research Site
Denver, North Carolina 28037
United States
Clinical Research Site
Fayetteville, North Carolina 28304
United States
Clinical Research Site
Huntersville, North Carolina 28078
United States
Clinical Research Site
Cincinnati, Ohio 45212
United States
Clinical Research Site
Cincinnati, Ohio 45245
United States
Clinical Research Site
Wyomissing, Pennsylvania 19610
United States
Clinical Research Site
Charleston, South Carolina 29425
United States
Clinical Research Site
Columbia, South Carolina 29201
United States
Clinical Research Site
Houston, Texas 77058
United States
Clinical Research Site
Houston, Texas 77070
United States
Clinical Research Site
San Antonio, Texas 78229
United States
Clinical Research Site
Sugar Land, Texas 77478
United States
Clinical Research Site
Spokane, Washington 99204
United States
Clinical Research Site
Calgary, Alberta T2Z 3A6
Canada
Clinical Research Site
Markham, Ontario L3R 1A3
Canada
Clinical Research Site
Ottawa, Ontario K2C 0P7
Canada
Clinical Research Site
Toronto, Ontario M4N 4M5
Canada
Clinical Research Site
Toronto, Ontario M5S 3A3
Canada