Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder
Summary
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
Description
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-mask, placebo-controlled, parallel study. The study has three phases: the pre-randomization phase, the randomization phase, and the open-label extension. The randomization phase comprises the evaluation segment during which subjects will be asked to take either tasimelteon or placebo approximately 1 hour prior to their target bedtime for 26 weeks in a double-mask fashion. Subjects that complete the study will be given the opportunity to participate in the optional open-label extension (OLE) phase. During this phase, subjects will take open-label 20mg tasimelteon for an additional 26 weeks.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Non-24-Hour Sleep-Wake Disorder
Intervention
tasimelteon, Placebo
Status
Not yet recruiting
Source
Vanda Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01163032
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Sleep Disorders, Circadian Rhythm
Dyssomnias associated with disruption of the normal 24 hour sleep wake cycle secondary to travel (e.g., JET LAG SYNDROME), shift work, or other causes.
Parasomnias
Movements or behaviors associated with sleep, sleep stages, or partial arousals from sleep that may impair sleep maintenance. Parasomnias are generally divided into four groups: arousal disorders, sleep-wake transition disorders, parasomnias of REM sleep, and nonspecific parasomnias. (From Thorpy, Sleep Disorders Medicine, 1994, p191)
Sleep-wake Transition Disorders
Parasomnias characterized by behavioral abnormalities that occur during the transition between wakefulness and sleep (or between sleep and wakefulness).
Sleep Disorders, Intrinsic
Dyssomnias (i.e., insomnias or hypersomnias) associated with dysfunction of internal sleep mechanisms or secondary to a sleep-related medical disorder (e.g., sleep apnea, post-traumatic sleep disorders, etc.). (From Thorpy, Sleep Disorders Medicine, 1994, p187)
Sleep Bruxism
A sleep disorder characterized by grinding and clenching of the teeth and forceful lateral or protrusive jaw movements. Sleep bruxism may be associated with TOOTH INJURIES; TEMPOROMANDIBULAR JOINT DISORDERS; sleep disturbances; and other conditions.
Clinical Trials
Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine
The purpose of this research study is to evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The safety and...
This study's first aim is to widen the knowledge of the characteristics of delayed sleep phase disorder (DSPS) by focusing on the circadian rhythms of appetite regulation factors and their...
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sle...
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
The aim of this study is to demonstrate the efficacy of timed exposure to bright light for the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia patien...
Tips for Infant and Parent Sleep (TIPS)
Infant and maternal sleep in the postpartum are related, and influenced by the mother's understanding of infant sleep behavior, the environmental and social cues for sleep presented to the...
PubMed Articles
The Use of Exogenous Melatonin in Delayed Sleep Phase Disorder: A Meta-analysis.
STUDY OBJECTIVES: To perform a meta-analysis of the efficacy and safety of exogenous melatonin in advancing sleep-wake rhythm in patients with delayed sleep phase disorder. DESIGN: Meta analysis of pa...
Introduction: Insomnia is a prevalent disorder with nearly 50% of the US adult population reporting insomnia symptoms during the past year and 10 - 15% reporting chronic insomnia. In addition, insomni...
OBJECTIVE: To determine the effects of sodium oxybate (SXB) on sleep physiology and sleep/wakerelated symptoms in patients with fibromyalgia syndrome (FM). METHODS: Of 304 patients with FM (American C...
Identification of Causal Genes, Networks, and Transcriptional Regulators of REM Sleep and Wake.
Sleep-wake traits are well-known to be under substantial genetic control, but the specific genes and gene networks underlying primary sleep-wake traits have largely eluded identification using convent...
Actigraphy for measurement of sleep and sleep-wake rhythms in relation to surgery.
Patients undergoing surgery have severe sleep and sleep-wake rhythm disturbances resulting in increased morbidity. Actigraphy is a tool that can be used to quantify these disturbances. The aim of this...
