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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Charles A. Czeisler, PhD, MD
Study ID
NCT04788953
Phase
PHASE4
Status
Terminated

Conditions

  • Excessive Sleepiness
  • Shift-work Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Solriamfetol Oral Tablet — DRUG
    The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
  • Placebo — DRUG
    Control subjects will receive placebo tablets for oral use.

Study Details

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).

Key Dates

Start date
Jul 21, 2021
Status verified
Sep 2025
Primary completion
Apr 6, 2024
Completion
Apr 19, 2024

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Solriamfetol (Sunosi)
    Participants will start at 75 mg and take that dose for 3 consecutive days. Participants will take their first 75mg dose on an early morning work day and take the next two 75 mg doses upon awakening regardless of their work schedule. They will then move to 150mg on the next early morning work day and for all subsequent early morning shift work days. The drug/placebo will be taken orally within 30 minutes after awakening, before the start of each early morning shift. Prior to the end of study of visit (Visit 5), drug will be taken at home within 30 minutes of awakening.
  • Placebo Comparator: Control
    Participants randomized into the Control arm will receive a placebo

Primary Outcome Measure

Change in Mean Sleep Latency [ Time Frame: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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