Efficacy of Ramelteon in Subjects With Chronic Insomnia

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.

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

Details

• Lead Sponsor: Takeda

Criteria

Inclusion Criteria

• Participant has participated in an allowed Ramelteon study and has completed all final visit procedures for the previous study within 21 days of the Treatment Initiation Visit for this study.

• 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.

• Investigator believes that participant requires long-term treatment for insomnia.

• Primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised for at least 3 months 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 Baseline Lead-in Period.

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

• Body mass index between 18 and 34, inclusive.

Exclusion Criteria

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

• Participated in any other investigational study, and/or taken any investigational drug within 30 days or five half-lives prior to Day 1 of study medication, whichever is longer. The only exception to this is prior participation in an allowed Ramelteon study.

• Sleep schedule changes required by employment (eg, shift worker) within three months prior to Day 1 of 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 Day 1 of study medication.

• 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 with the past 12 months.

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

• 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 Day 1 of 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(s) that in the Investigator's opinion would:

• affect sleep/wake function

• prohibit the subject from completing the study, or

• not be in the best interest of the subject to participate in the study.

• Morning serum cortisol at the Baseline visit of less than 7.0 micro-g per dl.

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

• Anxiolytics

• Hypnotics

• Antidepressants

• Anticonvulsants

• Sedating H1 antihistamines

• Systemic steroids

• Respiratory stimulants (eg, theophylline)

• Decongestants

• Over-the-counter and prescription stimulants

• Over-the-counter and prescription diet aids

• Central nervous system active drugs

• Narcotic analgesics

• Beta blockers

• St. John's Wort

• Kava-kava

• Gingko biloba

• Melatonin