Efficacy of Ramelteon in Subjects With Chronic Insomnia

Completed · Phase 3

Conditions studied: Sleep Initiation and Maintenance Disorders

In brief

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

Key facts

Study ID

NCT00671086

Run by

Takeda

People needed

1213

Starts

2003-02-01

Expected to finish

2004-09-01

Last updated by the study team

2012-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Burbank, California, United States
• Study site — Cerritos, California, United States
• Study site — Irvine, California, United States
• Study site — La Jolla, California, United States
• Study site — La Mesa, California, United States
• Study site — Lafayette, California, United States
• Study site — Murrieta, California, United States
• Study site — Newport Beach, California, United States
• Study site — Northridge, California, United States
• Study site — Redlands, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Monica, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Pueblo, Colorado, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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