Status:
COMPLETED
Long-Term Efficacy and Safety of Ramelteon in Adults With Chronic Insomnia.
Lead Sponsor:
Takeda
Conditions:
Chronic Insomnia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study to determine the long-term efficacy and safety of ramelteon, once daily (QD).
Detailed Description
A vast majority of people are affected by chronic insomnia in the western world. Several studies have looked at this and have estimated that 30% to 48% of the general population is affected at some ti...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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
- Beta blockers
- Sedating H1 antihistamines
- St. John's Wort
- Systemic steroids
- Kava-kava
- Respiratory stimulants
- Ginkgo-biloba
- Decongestants
- Over-the-counter and prescription stimulants
- Antipsychotics
- Over-the-counter and prescription diet aids
- Muscle Relaxants
- Melatonin and all other drugs or supplements known to affect sleep/wake function
- Any additional condition(s) that in the Investigator's opinion would
- affect sleep/wake function
- prohibit the subject from completing the study
- indicate that continuation in the study would not be in the best interests of the subject.
- History of hepatitis B or hepatitis C.
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT00247390
Start Date
July 1 2005
End Date
December 1 2006
Last Update
June 3 2010
Active Locations (48)
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1
Birmingham, Alabama, United States
2
Hot Springs, Arkansas, United States
3
Los Angeles, California, United States
4
Oakland, California, United States