Advertisement

Topics

Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder

2014-08-27 03:12:11 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:11-0400

Clinical Trials [2888 Associated Clinical Trials listed on BioPortfolio]

Study of the Pharmacokinetics and Safety of Tasimelteon Children With Non-24-Hour Sleep-Wake Disorder

Open-label, single-dose, non-controlled trial to evaluate the pharmacokinetics and safety of tasimelteon in children from 3 years to less than 18 years of age who are totally blind with no...

Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia

The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy individuals after a phase advance in jet lag type insomnia.

Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of lemborexant (4 dose levels) or placebo taken daily for 4 weeks in approximately 125 male or fem...

Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers

The purpose of this study is to test the hypothesis that ingestion of the wake-inhibiting drug suvorexant 30 minutes prior to daytime sleep initiation in individuals working overnight shif...

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 ...

PubMed Articles [6976 Associated PubMed Articles listed on BioPortfolio]

Efficacy of melatonin with behavioural sleep-wake scheduling for delayed sleep-wake phase disorder: A double-blind, randomised clinical trial.

Delayed Sleep-Wake Phase Disorder (DSWPD) is characterised by sleep initiation insomnia when attempting sleep at conventional times and difficulty waking at the required time for daytime commitments. ...

Placebo analgesia persists during sleep: An experimental study.

Although placebo analgesia is a well-recognized phenomenon with important clinical implications, the possibility that placebo effects occur during sleep has received little attention. This experimenta...

Sleep profile in anorexia and bulimia nervosa female patients.

Sleep wake cycle and eating patterns undergo major changes throughout life and have been proved to be very correlated. Eating disorder prevalence is increasing and sleep problems are very common among...

The role of sleep in emotional memory processing in middle age.

Sleep benefits memory in young adults, and this effect may be particularly strong for representations associated with negative emotion. Many aspects of sleep important for memory consolidation change ...

Wakefulness rather than sleep benefits extinction of an inhibitory operant conditioning memory in Aplysia.

Sleep enhances memory consolidation which has been shown in mammals as well as in invertebrates, like bees and Drosophila. The current study is part of a series of experiments examining whether this m...

Medical and Biotech [MESH] Definitions

Abnormal sleep-wake schedule or pattern associated with the CIRCADIAN RHYTHM which affect the length, timing, and/or rigidity of the sleep-wake cycle relative to the day-night cycle.

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.

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)

Parasomnias characterized by behavioral abnormalities that occur during the transition between wakefulness and sleep (or between sleep and wakefulness).

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)

More From BioPortfolio on "Efficacy and Safety of Tasimelteon Compared With Placebo in Totally Blind Subjects With Non-24-Hour Sleep-Wake Disorder"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Sleep Disorders
Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...


Searches Linking to this Trial