Clinical trial NCT06568367: Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Excessive Sleepiness
Shift-work Disorder
Keywords: Excessive Sleepiness
Solriamfetol
Sunosi
SWD
Dopamine norepinephrine reuptake inhibitor
Non-stimulant therapy
Insomnia
Circadian Rhythm Sleep Disorder
Trace amine-associated receptor 1 (TAAR1) agonist
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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: 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.

Primary outcomes:
measure: Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).
timeFrame: 12 weeks
measure: Change from Baseline to Week 12 in the Clinical Global Impressions of Severity of Illness (CGI-S) for sleepiness during the night shift.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Research Site
state: Arkansas
city: Cerritos
country: United States
facility: Clinical Research Site
state: California
city: Chula Vista
country: United States
facility: Clinical Research Site
state: California
city: Long Beach
country: United States
facility: Clinical Research Site
state: California
city: Santa Ana
country: United States
facility: Clinical Research Site
state: California
city: Colorado Springs
country: United States
facility: Clinical Research Site
state: Colorado
city: Hialeah
country: United States
facility: Clinical Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Clinical Research Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Research Site
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Site
state: Georgia
city: Lathrup Village
country: United States
facility: Clinical Research Site
state: Michigan
city: Novi
country: United States
facility: Clinical Research Site
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Clinical Research Site
state: Missouri
city: Denver
country: United States
facility: Clinical Research Site
state: North Carolina
city: Huntersville
country: United States
facility: Clinical Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Clinical Research Site
state: Ohio
city: Wyomissing
country: United States
facility: Clinical Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Site
state: South Carolina
city: Columbia
country: United States
facility: Clinical Research Site
state: South Carolina
city: San Antonio
country: United States
facility: Clinical Research Site
state: Texas
Study officials:
References: