A Study to Determine the Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
Information source: Takeda Global Research & Development Center, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Insomnia
Intervention: Ramelteon (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Takeda Global Research & Development Center, Inc. Official(s) and/or principal investigator(s):
Sherry Weigand, MD, PhD, Study Director, Affiliation: Takeda Global Research & Development Center, Inc.
Summary
This is a study to determine the efficacy and safety of 8mg of ramelteon over a six-month
period in adults with Chronic Insomina.
Clinical Details
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the long-term efficacy of ramelteon once daily in reduction of latency to persistent sleep compared with placebo in subjects with chronic insomnia.
Secondary outcome: Evaluate long-term treatment effects of ramelteon in improvement of sleep latency and duration objectively and subjectively.Evaluate the long term safety of ramelteon in the insomniac population.
Detailed description:
Subjects participating in this study will be randomly assigned to receive either 8 mg of
ramelteon or a placebo over a 6 month period (168 consecutive nights). There are a total of 5
polysomnogram treatment periods, with each polysomnogram treatment period encompassing 2
visit days and 3 consecutive calendar days. Subjects will report to a sleep laboratory and
have polysomnogram recordings for a total of 10 days. On all other nights, subjects will take
their study medication nightly at home as directed.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Adelaide, Australia
Camperdown, Australia
Victoria, Australia
Melbourne, Australia
Brussels, Belgium
Edegem, Belgium
Praha, Czech Republic
Praha 2, Czech Republic
Ceske Budejovice, Czech Republic
Ostrava-Poruba, Czech Republic
Espoo, Finland
Turku, Finland
Helsinki, Finland
Rouffach, France
Clamart Cedex, France
Paris, France
Bron, France
Garches, France
Schwerin, Germany
Schwalmstadt, Germany
Goettingen, Germany
Munster, Germany
Berlin, Germany
Hamburg, Germany
Milano, Italy
Moscow, Russian Federation
Samara, Russian Federation
Yekateringburg, Russian Federation
Saint Petersburg, Russian Federation
Irkutsk, Russian Federation
Birmingham, Alabama, United States
Hot Springs, Arkansas, United States
Los Angeles, California, United States
Oakland, California, United States
San Diego, California, United States
Santa Monica, California, United States
Naples, Florida, United States
Miami, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Overland Park, Kansas, United States
Louisville, Kentucky, United States
Chevy Chase, Maryland, United States
Lincoln, Nebraska, United States
New York, New York, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Columbia, South Carolina, United States
Austin, Texas, United States
Additional Information
Starting date: July 2005
Ending date: November 2006
Last updated: June 10, 2008
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