Non-24-Hour Sleep-Wake Disorder Clinical Trial
Official title:
An Extension Open-Label Safety Study of a 24-month 20 mg Dose Regimen of Tasimelteon for the Treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception Who Have Enrolled in Other Tasimelteon Clinical Trials
The purpose of this study is to evaluate the safety of tasimelteon in male and female patients who suffer from Non-24-Hour Sleep-Wake Disorder.
Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals 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 is < 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. As time
progresses, the endogenous circadian rhythm of sleep-wake propensity in these individuals
moves further and further away from the 24-hour light-dark cycle and gradually, these
individuals are unable to sleep at night and as a result experience extreme sleepiness
during the daytime hours and more frequent naps with a longer duration. Eventually, the
sleep-wake time moves back into alignment with the social time for sleep and the individuals
sleep well at night and have decreased daytime napping. The alignment between their
endogenous circadian rhythms and the 24-hour day is temporary as they are continually
drifting later and later each day.
The study is comprised of one 24-month treatment phase, as all subjects enrolled in the
trial have already been diagnosed with N24HSWD. Frequency of study visits will depend on the
subject's prior length of exposure to tasimelteon; accordingly, subjects will be assigned to
one of two groups upon enrollment into the study. The short-term exposure group will consist
of subjects for which it is possible at screening that they have been exposed to tasimelteon
for less than 6 months. The long-term exposure group will consist of subjects who have more
than 6 months of exposure to tasimelteon.
After completion of the 24-month treatment phase, subjects have the option to enroll into
the optional open-label extension sub-study for an additional 52 weeks. Frequency of visits
will be identical regardless of previous exposure (short term/long term).
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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
|
Phase 3 | |
| Completed |
NCT01163032 -
Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
|
Phase 3 |