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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

Criteria

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.