Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Vanda Pharmaceuticals

Stanford Investigator(s):


  • Drug: tasimelteon
  • Drug: Placebo


Phase 3


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

   - 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

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study


Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jamie Zeitzer
6504935000 x 62410