Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder (NCT04788953) | Clinical Trial Compass
TerminatedPhase 4
Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder
Stopped: Study was stopped due to funding limitations.
United States84 participantsStarted 2021-07-21
Plain-language 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).
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Men and women
✓. Ages 18 to 64 years
✓. Early-morning shift workers with a fixed work schedule (start times between 3 AM-6 AM, for at least 3 days per week)
✓. ≥ 20 work hours per week, 6-hour to 12-hour shifts
✓. ≥ 3-month history of working early morning shifts prior to the study
✓. Shift work disorder (as measured by 4-item SWD screening questionnaire and SWD symptoms confirmed by clinician) with excessive sleepiness (as measured by the modified ESS) specifically related to early morning shifts
✓. Baseline MWT average sleep latency \<20 minutes on the first 4 scheduled naps
✓. Body mass index 18.5 to 45 kg/m2
Exclusion criteria
✕. History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder, or surgical history that could affect the safety of the participant or interfere with study efficacy, safety, or the ability of the participant to complete the trial based on the judgment of the investigator.
✕. Presence of renal impairment or calculated creatinine clearance \< 60 mL/min.
✕. Laboratory value(s) outside the laboratory reference range that is considered to be clinically significant by the investigator (clinical chemistry, hematology, and urinalysis; see Appendix II).
What they're measuring
1
Change in Mean Sleep Latency
Timeframe: Study Visit 2 (i.e., Baseline Visit) and Study Visit 5 (i.e., End-of-Treatment Visit after 4 weeks on solriamfetol or placebo)
. Hypothyroidism or hyperthyroidism, unless stabilized by appropriate medication for at least 3 months prior to screening.
✕. Clinically significant EKG abnormality in the opinion of the investigator.
✕. Presence of significant cardiovascular disease including but not limited to: myocardial infarction within the past year, unstable angina pectoris, symptomatic congestive heart failure (ACC/AHA stage C or D), revascularization procedures within the past year, uncontrolled atrial fibrillation, ventricular cardiac arrhythmias requiring automatic implantable cardioverter defibrillator or medication therapy, uncontrolled hypertension, systolic blood pressure ≥ 155 mmHg or diastolic blood pressure ≥ 95 mmHg (at Screening or Baseline), or any history of cardiovascular disease or any significant cardiovascular condition that in the investigator's opinion may jeopardize participant safety in the study.
✕. History of bariatric surgery within the past year or a history of any gastric bypass procedure.
✕. Use of an MAOI in the past 14 days or five half-lives (whichever is longer) prior to the Baseline Visit, or plans to use an MAOI during the study.