Ramelteon in Adults With Chronic Insomnia

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in adult subjects with chronic insomnia.

• 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.

• Has had primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Text Revision and a history of daytime complaint(s) associated with disturbed sleep.

• Subjective sleep latency greater than or equal to 45 minutes and a subjective total sleep time less than or equal to 6.5 hours per night for at least 3 nights during the week of the lead-in period, based on subject diary.

• Habitual bedtime is between 8:30 PM and 12:00 AM.

• Body mass index between 18 and 34, inclusive.

Exclusion Criteria

• Known hypersensitivity to Ramelteon or related compounds, including melatonin.

• Previously participated in a study involving Ramelteon.

• Participated in any other investigational study, and/or taken any investigational drug within 30 days or five half-lives prior to the first day of single-blind study medication, whichever is longer.

• Sleep schedule changes required by employment (eg, shift worker) within three months prior to the first day of single-blind study medication, or has flown across greater than three time zones within seven days prior to screening.

• Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first day of single-blind study medication.

• Has ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.

• History of psychiatric disorder (including anxiety or depression) within the past 12 months.

• History of drug addiction or drug abuse within the past 12 months.

• History of alcohol abuse within the past 12 months.

• Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic or metabolic disease unless currently controlled and stable with protocol-allowed medication 30 days prior to the first day of single-blind study medication.

• Uses tobacco products during nightly awakenings.

• Any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.

• Positive hepatitis panel.

• Any additional condition that in the Investigator's opinion would:

• Affect sleep-wake function

• Prohibit the subject from completing the study

• Not be in the best interest of the subject.

• 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:

• melatonin or other drugs or supplements known to affect sleep/wake function.

• anxiolytics

• hypnotics

• antidepressants

• anticonvulsants

• sedating H1 antihistamines

• systemic steroids

• respiratory stimulants and decongestants

• over-the-counter and prescription stimulants

• over-the-counter and prescription diet aids

• central nervous system active drugs (including herbal preparations with central nervous system effects)

• narcotic analgesics

• beta blockers

• melatonin

• St. John's Wort

• kava-kava

• gingko biloba