Clinical Trial: Tasimelteon for the Treatment of Non-24-hour Sleep-Wake Disorder (N24HSWD) in Blind Individuals With no Light Perception

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Wi

Brief Summary: 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.

Detailed Summary:

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 w
Sponsor: Vanda Pharmaceuticals

Current Primary Outcome: Number of participants with Treatment-Emergent Adverse Events (AEs) [ Time Frame: 24 months + 12 month optional extension ]

Treatment-emergent adverse events will be summarized by presenting the number and percentage of patients having any treatment-emergent AE, having an AE in each body system, and having each individual AE.


Original Primary Outcome: Number of participants with Treatment-Emergent Adverse Events [ Time Frame: 24 months ]

Treatment-emergent adverse events will be summarized by presenting the number and percentage of patients having any treatment-emergent AE, having an AE in each body system, and having each individual AE.


Current Secondary Outcome:

  • Number of participants with changes in Clinical Laboratory Data [ Time Frame: 24 months + 12 month optional extension ]
    Standard Serum Hematology and Chemistry tests will be performed at baseline and through the 24 months of treatment
  • Number of participants with newly occurring or worsening ECG abnormalities [ Time Frame: 24 months + 12 month optional extension ]
  • Number of participants with clinically notable Vital Signs and Body Measurements [ Time Frame: 24 months + 12 month optional extension ]
  • Number of participants who report a positive result for the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 months + 12 month optional extension ]


Original Secondary Outcome:

  • Number of participants with changes in Clinical Laboratory Data [ Time Frame: 24 months ]
    Standard Serum Hematology and Chemistry tests will be performed at baseline and through the 24 months of treatment
  • Number of participants with newly occurring or worsening ECG abnormalities [ Time Frame: 24 months ]
  • Number of participants with clinically notable Vital Signs and Body Measurements [ Time Frame: 24 months ]
  • Number of participants who report a positive result for the C-SSRS [ Time Frame: 24 months ]


Information By: Vanda Pharmaceuticals

Dates:
Date Received: August 30, 2011
Date Started: October 2011
Date Completion:
Last Updated: April 20, 2015
Last Verified: April 2015