RECRUITING

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

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Conditions

Excessive SleepinessShift-work DisorderSolriamfetolSunosiSWDDopamine norepinephrine reuptake inhibitoNon-stimulant therapyInsomniaCircadian Rhythm Sleep DisorderTrace amine-associated receptor 1 (TAAR1) agonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2024-08-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06568367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD)
  2. * Provides written informed consent to participate in the study before the conduct of any study procedures.
  3. * Male or female, aged 18 to 65 inclusive.
  1. * Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
  2. * Unable to comply with study procedures.
  3. * Medically inappropriate for study participation in the opinion of the investigator.

Contacts and Locations

Study Contact

Study Director
CONTACT
212-332-5061
sol-swd-301@axsome.com

Study Locations (Sites)

Clinical Research Site
Chula Vista, California, 91910
United States
Clinical Research Site
Long Beach, California, 90805
United States
Clinical Research Site
Atlanta, Georgia, 30238
United States
Clinical Research Site
Stockbridge, Georgia, 30281
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
Columbia, South Carolina, 29201
United States
Clinical Research Site
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Axsome Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Excessive Sleepiness
  • Solriamfetol
  • Sunosi
  • SWD
  • Dopamine norepinephrine reuptake inhibito
  • Non-stimulant therapy
  • Insomnia
  • Circadian Rhythm Sleep Disorder
  • Trace amine-associated receptor 1 (TAAR1) agonist

Additional Relevant MeSH Terms

  • Excessive Sleepiness
  • Shift-work Disorder