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

Axsome Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Shift-work Disorder; Excessive Sleepiness

Treatments: Drug: Solriamfetol 300 mg; Drug: Placebo; Drug: Solriamfetol 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06568367

SOL-SWD-301

Details and patient eligibility

About

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).

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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520 participants in 3 patient groups, including a placebo group

Solriamfetol 150mg

Experimental group

Description:

Up to 12 weeks

Treatment:

Drug: Solriamfetol 150 mg

Solriamfetol 300mg

Experimental group

Description:

Up to 12 weeks

Treatment:

Drug: Solriamfetol 300 mg

Placebo

Placebo Comparator group

Description:

Up to 12 weeks

Treatment:

Drug: Placebo