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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, Arkansa

Clinical Research Site

Little Rock, Arkansa, United States, 72211

RECRUITING

United States, California

Clinical Research Site

Cerritos, California, United States, 90703

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, California

Clinical Research Site

Santa Anna, California, United States, 92705

RECRUITING

United States, Colorado

Clinical Research Site

Colorado Springs, Colorado, United States, 80918

RECRUITING

United States, Florida

Clinical Research Site

Hialeah, Florida, United States, 33016

RECRUITING

United States, Florida

Clinical Research Site

Miami, Florida, United States, 33144

RECRUITING

United States, Florida

Clinical Research Site

Miami, Florida, United States, 33176

RECRUITING

United States, Florida

Clinical Research Site

Miami, Florida, United States, 33186

RECRUITING

United States, Florida

Clinical Research Site

Miami Lakes, Florida, United States, 33016

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, Road cancer

Clinical Research Site

Lathrup Village, Road cancer, United States, 48076

RECRUITING

United States, Road cancer

Clinical Research Site

Novi, Road cancer, United States, 48377

RECRUITING

United States, Missouri

Clinical Research Site

Chesterfield, Missouri, United States, 63017

RECRUITING

United States, Missouri

Clinical Research Site

St louis, Missouri, United States, 63123

RECRUITING

United States, North Carolina

Clinical Research Site

Denver, North Carolina, United States, 28037

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

Charleston, South Carolina, United States, 29425

RECRUITING

United States, South Carolina

Clinical Research Site

Columbia, South Carolina, United States, 29201

RECRUITING

United States, Texas

Clinical Research Site

San Antonio, Texas, United States, 78229