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

ConditionsExcessive SleepinessShift-work Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAxsome Therapeutics, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

520 Participants
are divided into 3 treatment groups
Group A: Solriamfetol 150mgExperimental treatment 1 intervention
Group B: Solriamfetol 300mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Change from Baseline to Week 12 in the Clinical Global Impressions of Severity of Illness (CGI-S) for sleepiness during the night shift.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Axsome Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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