Non-24-Hour Sleep-Wake Disorder Clinical Trial
Official title:
A Randomized Withdrawal Study to Demonstrate the Maintenance of Effect of 20 mg Tasimelteon in the Treatment of N24HSWD
The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering 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.
This will be a multicenter, randomized withdrawal, double-masked, placebo-controlled,
parallel study. The study has three phases: the tasimelteon run-in phase, the tau estimation
phase, and the randomized withdrawal phase. Subjects who have participated in study
VP-VEC-162-3201 that meet the entry criteria for this study will be eligible for the run-in
phase The run-in phase comprises a screening visit where subject's initial eligibility will
be evaluated. Subjects that meet the inclusion/exclusion criteria at screening will enter
the run-in phase and will be dosed with 20 mg of tasimelteon daily for 6 weeks. The tau
estimation phase (48 hour urine collection samples to evaluate response to tasimelteon) will
follow the run-in phase and will last approximately 6 weeks long. The randomized withdrawal
phase comprises approximately eight weeks of treatment with either placebo or tasimelteon 20
mg taken approximately 1 hour prior to their target bedtime in a double-masked fashion.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01429116 -
Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception
|
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 |