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

Conditions

• Excessive Sleepiness
• Shift-work Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Solriamfetol 150 mg — DRUG
  Solriamfetol tablets, taken once daily
• Solriamfetol 300 mg — DRUG
  Solriamfetol tablets, taken once daily
• Placebo — DRUG
  Placebo tablets, taken once daily

Study Details

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).

Key Dates

First listed

Aug 23, 2024

Start date

Aug 1, 2024

Status verified

Jul 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

520 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Solriamfetol 150mg
  Up to 12 weeks
• Experimental: Solriamfetol 300mg
  Up to 12 weeks
• Placebo Comparator: Placebo
  Up to 12 weeks

Primary Outcome Measure

Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT). [ Time Frame: 12 weeks ]

Central Contacts

• Study Director
  212-332-5061
  [email protected]

Locations (44)

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