A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon Versus Placebo in Totally Blind Subjects With N24HSWD Followed by an OLE Phase

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 now accepting new patients for this trial. Please contact Jamie Zeitzer at 6504935000 x 62410 for more information.

Investigator(s):

Intervention(s):

  • drug : placebo
  • drug : tasimelteon

Phase: Phase 3

Eligibility

Ages Eligible For Study:

18 Years - 75 Years

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;

External Links

Contact information

Primary Contact:

Jamie Zeitzer 6504935000 x 62410

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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