Status:
COMPLETED
Efficacy of Ramelteon in Subjects With Chronic Insomnia
Lead Sponsor:
Takeda
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.
Detailed Description
Insomnia is characterized by difficulties initiating and maintaining sleep or complaints of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
1213 Patients enrolled
Trial Details
Trial ID
NCT00671086
Start Date
February 1 2003
End Date
September 1 2004
Last Update
February 28 2012
Active Locations (122)
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Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Phoenix, Arizona, United States
4
Tempe, Arizona, United States