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.
- drug : placebo
- drug : tasimelteon
Phase: Phase 3
Ages Eligible For Study:
- 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;