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Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder

NCT04788953 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-09-24

Study results available
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Summary

In this research study the investigators want to learn more about whether the medication Solriamfetol improves daytime sleepiness in workers who start work at very early times (between 3 and 6am).

Conditions

  • Excessive Sleepiness
  • Shift-work Disorder

Interventions

DRUG

Solriamfetol Oral Tablet

The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019

DRUG

Placebo

Control subjects will receive placebo tablets for oral use.

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    collaborator INDUSTRY

  • Charles A. Czeisler, PhD, MD

    lead OTHER

Principal Investigators

  • Charles A Czeisler, PhD,MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2024-04-06
Completion
2024-04-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04788953 on ClinicalTrials.gov