Transient Insomnia Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Single-Dose Study of TAK-375 in Healthy Adult Volunteers in a Sleep Lab Model of Transient Insomnia
Verified date | February 2012 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily (QD), in healthy subjects within a sleep lab.
Status | Completed |
Enrollment | 289 |
Est. completion date | May 2003 |
Est. primary completion date | May 2003 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
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. - Habitual bedtime is between 8:30 p.m. and 12:00 a.m. - Sleeps 6.5 to 8 hours per night and has a subjective sleep latency of less than or equal to 30 minutes. - Body mass index between 18 and 34, inclusive. Exclusion Criteria: - Any history of insomnia. - Spent one or more nights in a sleep laboratory. - Epworth Sleepiness Scale score of greater than 10. - 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 Day 1, whichever is longer. - Sleep schedule changes required by employment (ie, shift work) within three months preceding Day 1 or has flown across greater than three time zones within seven days prior to screening. - Participated in a weight loss program or substantially altered their exercise routine within 30 days prior to Day 1. - History of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder. - History of a psychiatric disorder (including anxiety or depression) within the past 12 months. - History of drug addiction or drug abuse within the past 12 months. - Any physical or psychiatric disorder that may be associated with sleep disturbance. - 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 4 or more alcoholic drinks per day. - Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic or metabolic disease. - 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. - Positive urine drug screen including alcohol at screening or a positive breathalyzer test at check-in. - Any additional condition(s) 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, 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 - All beta blockers - St. John's Wort - Kava-kava - gingko biloba |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Takeda |
United States,
Zammit G, Schwartz H, Roth T, Wang-Weigand S, Sainati S, Zhang J. The effects of ramelteon in a first-night model of transient insomnia. Sleep Med. 2009 Jan;10(1):55-9. doi: 10.1016/j.sleep.2008.04.010. Epub 2008 Aug 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Latency to Persistent Sleep from 1 night of polysomnography (PSG) recording in a sleep laboratory. | Day 1 | No | |
Secondary | Total Sleep Time. | Days 1 and 2. | No | |
Secondary | Sleep Efficiency. | Days 1 and 2. | No | |
Secondary | Wake Time after Persistent Sleep Onset. | Days 1 and 2. | No | |
Secondary | Number of Awakenings after Persistent Sleep. | Days 1 and 2. | No | |
Secondary | Subjective Sleep Latency. | Day 2 | No | |
Secondary | Subjective Total Sleep Time. | Day 2 | No | |
Secondary | Subjective Sleep Quality. | Day 2 | No | |
Secondary | Subjective Wake Time after Sleep Onset. | Day 2 | No | |
Secondary | Subjective Number of Awakenings. | Day 2 | No | |
Secondary | Subjective Ease of Falling Back to Sleep after Awakening. | Day 2 | No | |
Secondary | Stage 1 Nonrapid Eye Movement (NREM) Sleep | Day 2. | No | |
Secondary | Stage 2 Nonrapid Eye Movement (NREM) Sleep | Day 2. | No | |
Secondary | Stage 3/4 Nonrapid Eye Movement (NREM) Sleep | Day 2. | No | |
Secondary | Latency to Rapid Eye Movement (REM) Sleep | Day 2. | No | |
Secondary | Percentage of Total Sleep Time in REM Sleep | Day 2. | No |
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