Efficacy of Ramelteon in Adults With Chronic Insomnia

• Status: Terminated
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate subjectively reported treatment effects of ramelteon, once daily (QD), in adults 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 chronic insomnia as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months.

• Reports a history of subjective sleep latency greater than or equal to 60 min and a subjective total sleep time less than 6.5 hours.

• Habitual bedtime is between 10:00 PM and 1:00 AM.

• Willing to have a fixed bedtime and agrees to go to bed within plus or minus 30 minutes of the habitual bedtime during the entire study.

• Consistent access to a touch tone phone and are willing to complete telephone questionnaires twice daily during participation in the study.

• Willing to remain in bed for at least 6.5 hours each night during the entire study.

• Used pharmacological assistance to sleep 0-4 times per week in the last 3 months.

• Must complete the morning questionnaire on at least 4 of the first 7 mornings after Screening Visit 1.

• On at least 3 of the first 5 nights of single-blind placebo treatment, the subject must have a subjective sleep latency of greater than or equal to 45 minutes.

• On at least 3 of the first 5 nights of single-blind placebo treatment, the subject must have a subjective total sleep time of less than 6.5 hours.

Exclusion Criteria

• Known hypersensitivity to ramelteon or related compounds, including melatonin, and 5-hydroxytryptophan.

• Participated in any other investigational study and/or took any investigational drug within 30 days prior to the first dose of single-blind study medication.

• Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of single-blind study medication.

• Has flown across greater than 3 time zones within 7 days prior to screening, or will travel across 2 or more time zones during the course of the study.

• Participated in a weight loss program or has substantially altered exercise routine within 30 days prior to the first night of singleblind study medication.

• Ever had a history of seizures, sleep apnea, and/or chronic obstructive pulmonary disease.

• History of psychiatric disorder within the past 6 months.

• History of fibromyalgia.

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

• History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised and/or regularly consumes more than 2 alcoholic drinks per day.

• Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, 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.

• Uses tobacco products or any other products that may interfere with the sleep wake cycle 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(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.

• Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:

• Anxiolytics

• Central nervous system active drugs

• Hypnotics

• Narcotic analgesics

• Antidepressants

• Beta blockers

• Anticonvulsants

• St. John's Wort

• Sedating H1 antihistamines

• Kava-kava

• Systemic steroids

• Ginkgo-biloba

• Respiratory stimulants

• Over-the-counter and prescriptions stimulants

• Decongestants

• Over-the-counter and prescription diet aids

• Antipsychotics

• Melatonin and all other drugs or supplements known to affect sleep/wake