The purpose of this study is to evaluate the safety of a one year open-label treatment of tasimelteon 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, open-label study. The study has two phases: the screening phase and the evaluation phase. The screening phase is comprised of a screening visit where a patient's general health and initial eligibility will be evaluated. The evaluation phase is comprised of a baseline visit and a 52 week segment. Patients that meet all entry criteria for the study at baseline visit will enter the treatment segment where patients will be asked to take 20 mg tasimelteon daily approximately 60 minutes prior to their target bedtime for 52 weeks in an open-label fashion. An optional sub-study extension phase is available to subjects who complete the first year of treatment and consists of continued open-label treatment for up to 3 years additional.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
20 mg tasimelteon capsules, PO daily for 1 year
Unnamed facility
Garches, France
Unnamed facility
Lille, France
Unnamed facility
Lyon, France
Unnamed facility
Montpellier, France
Unnamed facility
Paris, France
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time frame: Week 4
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time frame: Week 8
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time frame: Week 12
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time frame: Week 16
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time frame: Week 26
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time frame: Week 34
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Unnamed facility
Rennes, France
Unnamed facility
Toulouse, France
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time frame: Week 42
Safety Evaluations
the recording of adverse events (AEs), clinical laboratory evaluations including labs, vital signs, and electrocardiograms(ECGs). The Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal behavior and ideation.
Time frame: Week 52
Patient Global Impression of Change (PGI-C)
A patient rated assessment of reported nighttime sleep
Time frame: Weeks 8, 16, 26, 34, 42, 52
Clinical Global Impression of Change (CGI-C)
rate of total improvement due to drug as viewed by the clinician
Time frame: Weeks 8, 16, 26, 34, 42, 52
Patient Global Impression of Change (PGI-C)
A patient rated assessment on daytime naps
Time frame: Weeks 8, 16, 26, 34, 42, 52