The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab.
Insomnia is characterized by difficulties initiating and maintaining sleep, or of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects. Ramelteon is a selective melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders. This study is being conducted to evaluate the safety and efficacy of a single dose of Ramelteon in normal healthy subjects in a sleep lab model of transient insomnia. Participation is this study is anticipated to be about 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
289
Unnamed facility
Palm Springs, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Pembroke Pines, Florida, United States
Latency to Persistent Sleep from 1 night of polysomnography (PSG) recording in a sleep laboratory.
Time frame: Day 1
Total Sleep Time.
Time frame: Days 1 and 2.
Sleep Efficiency.
Time frame: Days 1 and 2.
Wake Time after Persistent Sleep Onset.
Time frame: Days 1 and 2.
Number of Awakenings after Persistent Sleep.
Time frame: Days 1 and 2.
Subjective Sleep Latency.
Time frame: Day 2
Subjective Total Sleep Time.
Time frame: Day 2
Subjective Sleep Quality.
Time frame: Day 2
Subjective Wake Time after Sleep Onset.
Time frame: Day 2
Subjective Number of Awakenings.
Time frame: Day 2
Subjective Ease of Falling Back to Sleep after Awakening.
Time frame: Day 2
Stage 1 Nonrapid Eye Movement (NREM) Sleep
Time frame: Day 2.
Stage 2 Nonrapid Eye Movement (NREM) Sleep
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Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Overland Park, Kansas, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Dublin, Ohio, United States
...and 2 more locations
Time frame: Day 2.
Stage 3/4 Nonrapid Eye Movement (NREM) Sleep
Time frame: Day 2.
Latency to Rapid Eye Movement (REM) Sleep
Time frame: Day 2.
Percentage of Total Sleep Time in REM Sleep
Time frame: Day 2.