Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
Condition: Non-24-Hour Sleep-Wake Disorder
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Intervention: tasimelteon; Placebo
Intervention description: 20 mg tasimelteon capsules, PO daily for 6 months; Placebo capsules, PO daily for 6 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Blindness; Eye Diseases; Nap Disorders; Circadian Rhythm Disorders; Sleep disorders; Circadian Rhythm Sleep Disorders; Dyssomnias; Nervous System Diseases

Summary:

      The purpose of this study is to evaluate the efficacy and safety of a six month double-mask
      treatment of tasimelteon or placebo in male and female subjects with Non-24-Hour Sleep-Wake
      Disorder
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability and acceptance to provide informed consent;

          -  No perception of light by the subject's own report;

          -  Diagnosis of N24HSWD as determined by:

               1. History (within the last 3 months) of trouble sleeping at night difficulty
                  initiating sleep or staying asleep), difficulty awakening in the morning, or
                  daytime sleepiness as determined by answering yes to at least one question in the
                  Sleep Complaint Questionnaire and

               2. Urinary aMT6s demonstrates a progressive delay of the aMT6 acrophase time.

          -  Willing and able to comply with study requirements and restrictions including a
             commitment to a fixed 9-hour sleep opportunity during the study;

          -  Fluent in English;

        Exclusion Criteria:

          -  Have a probable diagnosis of a current sleep disorder other than N24HSWD that is the
             primary cause of the sleep disturbance based on clinical investigator medical
             judgment;

          -  Current clinically significant cardiovascular, respiratory, neurologic, hepatic,
             hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently
             controlled and stable;

          -  History (within the 12 months prior to screening) of psychiatric disorders including
             Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium
             or any other psychiatric disorder that in the opinion of the clinical investigator
             would affect participation in the study or full compliance with study procedures;

          -  History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;

          -  Worked night, rotating, or split (period of work, followed by break, and then return
             to work) shift work within 1 month of the screening visit or plan to work these shifts
             during the study;

          -  Unable to perform calls to the study IVR system to report questionnaire results;

          -  Exposure to any investigational drug, including placebo, within 30 days or 5 half
             lives (whichever was longer) of screening;

          -  Use of central nervous system prescription or OTC medications, other than melatonin,
             that affects the sleep-wake cycle

          -  Use of melatonin or melatonin agonist