Chronic Insomnia Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Determine the Safety and Efficacy of TAK-375 in Elderly Subjects With Chronic Insomnia.
This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily (QD), in elderly subjects with chronic insomnia.
Insomnia is characterized by a complaint of difficulties initiating and maintaining sleep or
of nonrestorative 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 melatonin-1 receptor agonist under global development by Takeda Chemical
Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for
the treatment of Circadian Rhythm Sleep Disorders.
Participation in this study is anticipated to be about 2 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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