Safety and Efficacy of Ramelteon in Healthy Subjects
Condition: Sleep Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the phase-advance in circadian rhythms in healthy
      adults subjects taking ramelteon, once daily (QD).
    

Detailed description: 
      Circadian rhythms are the innate daily fluctuation of physiologic or behavior functions,
      included sleep-wake states, generally tied to the 24-hour daily dark-light cycle. Circadian
      Rhythm Sleep Disorders share a common chronophysiologic basis in which the major feature is a
      misalignment between the patient's sleep pattern and the sleep pattern that is desired or
      regarded as the societal norm.

      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.
    

Intervention name(s): Ramelteon; Ramelteon; Ramelteon; Ramelteon; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ramelteon 1 mg, tablets, orally once daily for up to 5 days; Ramelteon 2 mg, tablets, orally once daily for up to 5 days; Ramelteon 4 mg, tablets, orally once daily for up to 5 days; Ramelteon 8 mg, tablets, orally once daily for up to 5 days; Ramelteon placebo-matching tablets, orally once daily for up to 5 days
Other intervention name(s): Rozerem™; TAK-375; Rozerem™; TAK-375; Rozerem™; TAK-375; Rozerem™; TAK-375
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Disorder; Circadian Rhythm Sleep Disorder; Drug Therapy