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
Study type: Interventional
Phase: Phase 3

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
    

Detailed description: 
      Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals, primarily those without
      light perception, are unable to synchronize their endogenous circadian pacemaker to the
      24-hour light-dark cycle, and the timing of their circadian rhythm instead reflects the
      intrinsic period of their endogenous circadian pacemaker. As a result, the circadian rhythm
      of sleep-wake propensity in these individuals moves gradually later and later each day if
      there circadian period is > 24 hours and earlier and earlier if < 24 hours. These individuals
      will be able to sleep well at night when their sleep-wake propensity rhythm is approximately
      aligned with the 24-hour light-dark and social cycle. However, after a short time, the
      endogenous sleep-wake propensity rhythm and the 24-hour light-dark cycle will move out of
      synchrony with each other, and they may have difficulty falling asleep until well into the
      night. In addition to problems sleeping at the desired time, the subjects experience daytime
      sleepiness and daytime napping.

      This will be a multicenter, randomized, double-masked, placebo-controlled, parallel study.
      The study has two phases: the pre-randomization phase followed by either the randomization
      phase or the open-label extension (OLE). The pre-randomization phase comprises a screening
      visit where subject's initial eligibility will be evaluated, a circadian period (τ)
      estimation segment, and a variable-length in-phase transition segment in which subjects will
      wait to start treatment until their circadian phase is aligned with their target bedtime.
      Subjects that meet all entry criteria for the study will enter the randomization phase.
      During the randomization phase, subjects will be asked to take either 20 mg tasimelteon or
      placebo approximately 1 hour prior to their target bedtime for 26 weeks in a double-masked
      fashion. Subjects who have a τ greater than 24.0 and meet all entry criteria but that are
      ineligible for the randomization phase due to their τ estimate may be given the opportunity
      to participate in the OLE phase. During the OLE phase, subjects will take open-label 20mg
      tasimelteon for 26 weeks.
    

Intervention name(s): tasimelteon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg tasimelteon capsules, PO daily for 6 months; Placebo capsules, PO daily for 6 months
Other intervention name(s): VEC-162
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blindness; Eye Diseases; Nap Disorders; Circadian Rhythm Disorders; Sleep disorders; Circadian Rhythm Sleep Disorders; Dyssomnias; Nervous System Diseases