Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

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

NCT06568367 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • DRUG Placebo
  • DRUG Solriamfetol 150 mg
  • DRUG Solriamfetol 300 mg

Study Locations (20)

Florida

  • Clinical Research Site — Brandon
  • Clinical Research Site — Hialeah
  • Clinical Research Site — Miami
  • Clinical Research Site — Miami
  • Clinical Research Site — Miami
  • Clinical Research Site — Miami Lakes

California

  • Clinical Research Site — Cerritos
  • Clinical Research Site — Chula Vista
  • Clinical Research Site — Huntington Beach
  • Clinical Research Site — Long Beach
  • Clinical Research Site — Santa Ana

Arizona

  • Clinical Research Site — Chandler
  • Clinical Research Site — Tucson

Georgia

  • Clinical Research Site — Atlanta
  • Clinical Research Site — Stockbridge

Alabama

  • Clinical Research Site — Cullman

Arkansas

  • Clinical Research Site — Little Rock

Colorado

  • Clinical Research Site — Colorado Springs

Maryland

  • Clinical Research Site — Towson

Trial Details

FieldValue
Enrollment Target 520 participants
Start Date 2024-08-01
Est. Completion 2026-12
Phase Phase 3

Sponsor

Axsome Therapeutics

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06568367

The ClinicalTrials.gov registry entry for NCT06568367 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Shift-work Disorder appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06568367 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06568367 about?

NCT06568367 is a clinical study titled "Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)". 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 w...

What is the current status of trial NCT06568367?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 520 participants. The study started on 2024-08-01. Estimated completion is 2026-12.

What conditions does trial NCT06568367 study?

This clinical trial studies the following conditions: Shift-work Disorder, Excessive Sleepiness. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06568367?

The interventions under investigation include: Placebo (DRUG), Solriamfetol 150 mg (DRUG), Solriamfetol 300 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06568367?

This trial is sponsored by Axsome Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06568367 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial