The study will involve an evaluation of the efficacy and safety of ramelteon (TAK-375) over a 6-month period in adults and elderly subjects with chronic insomnia. The test agent ramelteon will be used at 8 mg fixed dose and the study will be conducted in multiple sites.
Official Title
A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia
Conditions
Chronic Insomnia
Study Type
Interventional
Study Design
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Further Details
Primary Outcome Measures:
- Reduction in latency to persistent sleep.
Study Start
July 2005; Expected completion: November 2006
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
Inclusion Criteria:
- Subjects will be at least 18 years of age, male or female with a usual bedtime between 10 PM and 1 AM.
- Subjects have had difficulty initiating or maintaining sleep, or of nonrestorative sleep, that lasts at least 3 months and that causes significant distress or difficulty in social, occupational, or other important areas of function.
- The disturbance in sleep does not occur exclusively during the course of another sleep disorder or mental disorder and is not the direct physiological effect of a substance or a general medical condition.
- Subjects generally report sleeping less than 6.5 hours per night, and it takes more than 45 minutes to get to sleep.
Exclusion Criteria:
- Subjects who have known hypersensitivity to ramelteon or related compounds, including melatonin.
- Use of melatonin, sedative-hypnotic, stimulants, or other drugs/supplements known to affect sleep/wake function, within 1 week (or 5 half lives of the drug, whichever is the longer) prior to the first day of single-blind study medication.
- The subject has had sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of single-blind study medication. The subject has flown across greater than 3 time zones within 21 days prior to or during screening.
- The subject has ever had a history of seizures, sleep apnea, RLS, PLMS, COPD, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder, or subjects with a history of alcohol/drug abuse within the past 12 months.
Total Enrolment
476
Contact Details
Locations:
- Adelaide, Australia
- Camperdown, Australia
- Victoria, Australia
- Melbourne, Australia
Shoona Vincent, PhD, DM: svincent@tgrd.comDavid JB Kim, B.S: dkim@tgrd.com
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