Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2005-03-31
2005-05-31
Brief Summary
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Detailed Description
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Circadian Rhythm Sleep Disorders affect a sizable portion of the United States population, representing a significant underserved need. It has been estimated that 7% of all adolescents suffer from Delayed Sleep Phase Syndrome. Approximately 1% of all middle-aged people have Advanced Sleep Phase Syndrome. There are 21 million people who are shift workers and between 5% to 20% of these workers develop severe symptoms of Shift Work Sleep Disorder soon after starting shift work. Time Zone Change (Jet Lag) Syndrome can affect millions of travelers each year. Most symptoms are a result of sleep deprivation.
Current treatment of these disorders include behavioral therapy, light therapy and use of hypnotics and stimulants. Melatonin has also been used with mixed results.
The effects of melatonin on circadian phase depend on the time at which it is administered, and are generally opposite those of light. Specifically, melatonin given in the evening results in an advance of the circadian system to an earlier hour ("phase advance"). While melatonin appears to be useful in the treatment of sleep disruption in the blind, the phase shifting ability of native melatonin is much less than that of light, limiting its utility in the treatment of circadian dysfunction in sighted individuals.
Ramelteon is under global development as a sleep-promoting agent. Ramelteon demonstrates affinity and selectivity for human melatonin-1 or melatonin-2 receptors. Ramelteon also demonstrates full agonist activity relative to melatonin in cells expressing human melatonin-1 or melatonin-2 receptors.
The purpose of this study is to determine whether ramelteon given over multiple days can produce a phase advance in circadian rhythms as measured in salivary melatonin levels in dim-light conditions. Participation in this study is anticipated to be about 4 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ramelteon 1 mg QD
Ramelteon
Ramelteon 1 mg, tablets, orally once daily for up to 5 days
Ramelteon 2 mg QD
Ramelteon
Ramelteon 2 mg, tablets, orally once daily for up to 5 days
Ramelteon 4 mg QD
Ramelteon
Ramelteon 4 mg, tablets, orally once daily for up to 5 days
Ramelteon 8 mg QD
Ramelteon
Ramelteon 8 mg, tablets, orally once daily for up to 5 days
Placebo QD
Placebo
Ramelteon placebo-matching tablets, orally once daily for up to 5 days
Interventions
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Ramelteon
Ramelteon 1 mg, tablets, orally once daily for up to 5 days
Ramelteon
Ramelteon 2 mg, tablets, orally once daily for up to 5 days
Ramelteon
Ramelteon 4 mg, tablets, orally once daily for up to 5 days
Ramelteon
Ramelteon 8 mg, tablets, orally once daily for up to 5 days
Placebo
Ramelteon placebo-matching tablets, orally once daily for up to 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Habitual bedtime is between 10:00 p.m. and 1:00 a.m.
* Body mass index between 18 and 30, inclusive.
* Medial subjective sleep latency of less than 30 minutes and a median subjective total sleep time of greater than 6.5 but less than 9 hours.
Exclusion Criteria
* Previously participated in a study involving ramelteon.
* Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
* Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication.
* Flown across greater than three time zones within 21 days prior to or during screening.
* Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of single-blind study medication.
* Ever had a history of seizures, sleep apnea, restless leg syndrome, periodic limb movement syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
* History of primary sleep disorders as determined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised within the past 6 months.
* History of psychiatric disorder (including anxiety or depression) within the past 12 months.
* History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or consumes any alcoholic drinks 2 hours prior to bedtime.
* History of drug abuse within the past 12 months.
* Current neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease.
* Apnea hypopnea index (per hour of sleep) greater than 10.
* Periodic leg movement syndrome with arousal index (per hour of sleep) greater than 10 as seen on the polysomnography screening night.
* Positive urine drug screen.
* Smokes greater than 3 cigarettes per day or uses tobacco products during nightly awakenings.
* Reports high caffeine consumption (greater than 500 mg daily).
* Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.
* Positive hepatitis panel including anti-hepatitis.
* Unwilling to remain in the sleep laboratory in dim-light conditions for 5 days and nights or fully cooperate with site personnel.
* Any additional condition(s) that in the Investigator's opinion would:
* affect sleep/wake function
* prohibit the subject from completing the study
* not be in the best interest of the subject.
* Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:
* Anxiolytics
* Central nervous system active drugs (including herbal)
* Antipsychotics
* Narcotic analgesics
* Antidepressants
* Beta blockers
* Anticonvulsants
* St. John's Wort
* Sedating H1 antihistamines
* Kava-kava
* Systemic steroids
* Ginkgo-biloba
* Respiratory stimulants
* Over the counter and prescription stimulants
* Decongestants
* Over-the-counter and prescription diet aids
18 Years
45 Years
ALL
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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VP Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Hot Springs, Arkansas, United States
Los Angeles, California, United States
San Diego, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Danville, Indiana, United States
Overland Park, Kansas, United States
Metairie, Louisiana, United States
Chevy Chase, Maryland, United States
Las Vegas, Nevada, United States
Dublin, Ohio, United States
Columbia, South Carolina, United States
Countries
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References
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Richardson GS, Zee PC, Wang-Weigand S, Rodriguez L, Peng X. Circadian phase-shifting effects of repeated ramelteon administration in healthy adults. J Clin Sleep Med. 2008 Oct 15;4(5):456-61.
Related Links
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Other Identifiers
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U1111-1114-8304
Identifier Type: REGISTRY
Identifier Source: secondary_id
01-02-TL-375-018
Identifier Type: -
Identifier Source: org_study_id
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