Chronic Insomnia Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Elderly Subjects With Chronic Insomnia
This purpose of this study is to evaluate the safety and effectiveness of Ramelteon, once daily (QD), in elderly participants with chronic insomnia.
Insomnia is characterized by a complaint of initiating and maintaining sleep or complaints
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 selective melatonin-1 receptor agonist under development by Takeda Chemical
Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment
of Circadian Rhythm Sleep Disorders.
Ramelteon is the first candidate in a novel class of drugs based on this mechanism. Based on
non-clinical and clinical studies completed to date, TAK-375 has the potential to offer
unique advantages relative to approved hypnotics in terms of its pharmacological profile and
its selectivity to the melatonin-1 receptor.
This study is designed to determine the safety and efficacy of 35-day treatment of chronic
insomnia with ramelteon. Participation in this study is anticipated to be approximately 2
months.
;
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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