Non-24-Hour Sleep-Wake Disorder Clinical Trial
Official title:
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
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01430754 -
Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
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Phase 3 | |
| Completed |
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Phase 3 |