Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Insomnia

In brief

The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).

Key facts

Study ID

NCT00247390

Run by

Takeda

People needed

451

Starts

2005-07-01

Expected to finish

2006-12-01

Last updated by the study team

2010-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Body mass index between 18 and 34, inclusive.
• Based on sleep history, has had chronic insomnia for at least 3 months.
• Based on sleep history, reports a subjective sleep latency greater than or equal to 45 min and a subjective total sleep time less than or equal to 6.5 hours.
• Based on sleep history, habitual bedtime is between 10:00 PM and 1:00 AM.
• Mean latency to persistent sleep of greater than 20 minutes on two consecutive screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes.
• Based on sleep history, normally uses pharmacological assistance to sleep 0 to 4 times per week in the last 3 months.

You may not qualify if…

• Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds.
• Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.
• Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication.
• Flown across greater than three time zones within 7 days prior to or during screening.
• Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of single-blind study medication.
• Has ever had a history of seizures, sleep apnea, restless leg syndrome, periodic leg movement syndrome, chronic obstructive pulmonary disease or fibromyalgia.
• History of psychiatric disorder within the past 6 months.
• History of alcohol abuse within the past 12 months, as defined in Diagnostic \& Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week, or consumed any alcoholic drinks within 24 hours of any polysomnogram visits.
• History of drug abuse within the past 12 months, as defined in Diagnostic \& Statistical Manual of Mental Disorders, 4th Edition Revised.
• Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of single-blind study medication.
• Apnea hypopnea index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night.
• Periodic Leg Movement Syndrome with arousal index (per hour of sleep) greater than 10 as seen on the first polysomnogram screening night.
• Positive urine drug screen at Screening Visit 1 or any of the polysomnogram assessment visits.
• Positive breathalyzer test on any of the polysomnogram assessment visits.
• Uses tobacco products (including nicotine gum and patch) or any other products that may interfere with the sleep wake cycle during nightly awakenings.
• Used any central nervous system medication or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the administration of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
• Intends to continue taking any disallowed medication or any prescription medication or over the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication. The subject must report all prescription and over the counter medications taken in the three weeks prior to screening.
• Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• Anxiolytics
• Sedatives
• Hypnotics
• CNS active drugs (including herbal)
• Antidepressants
• Narcotic analgesics
• Anticonvulsants

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Monica, California, United States
• Study site — Miami, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Overland Park, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Chevy Chase, Maryland, United States
• Study site — Lincoln, Nebraska, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Columbia, South Carolina, United States
• Study site — Austin, Texas, United States
• Study site — Adelaide, Australia
• Study site — Camperdown, Australia
• Study site — Melbourne, Australia
• Study site — Victoria, Australia
• Study site — Brussels, Belgium
• Study site — Edegem, Belgium

Full record on ClinicalTrials.gov

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