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NCT06568367 | RECRUITING | Excessive Sleepiness

Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
Sponsor:

Axsome Therapeutics, Inc.

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).

Condition or disease

Excessive Sleepiness

Shift-work Disorder

Intervention/treatment

Solriamfetol 150 mg

Solriamfetol 300 mg

Placebo

Phase

PHASE3

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 Type : INTERVENTIONAL
Estimated Enrollment : 520 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-08-01
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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.
Exclusion Criteria
  • * 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.
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

Location Details

NCT06568367

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Clinical Research Site

Chula Vista, California, United States, 91910

RECRUITING

United States, California

Clinical Research Site

Long Beach, California, United States, 90805

RECRUITING

United States, Georgia

Clinical Research Site

Atlanta, Georgia, United States, 30238

RECRUITING

United States, Georgia

Clinical Research Site

Stockbridge, Georgia, United States, 30281

RECRUITING

United States, North Carolina

Clinical Research Site

Huntersville, North Carolina, United States, 28078

RECRUITING

United States, Ohio

Clinical Research Site

Cincinnati, Ohio, United States, 45212

RECRUITING

United States, Ohio

Clinical Research Site

Cincinnati, Ohio, United States, 45245

RECRUITING

United States, Pennsylvania

Clinical Research Site

Wyomissing, Pennsylvania, United States, 19610

RECRUITING

United States, South Carolina

Clinical Research Site

Columbia, South Carolina, United States, 29201

RECRUITING

United States, Texas

Clinical Research Site

Saint Anthony, Texas, United States, 78229