Transient Insomnia Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Single-Dose Study of TAK-375 in Healthy Adult Volunteers in a Sleep Lab Model of Transient Insomnia
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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