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Study of Efficacy of Ramelteon in Adults With Chronic Insomnia

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ClinicalTrials.gov Identifier: NCT00671125
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep

Condition or disease Intervention/treatment Phase
Chronic Insomnia Drug: Ramelteon Drug: Placebo Phase 3

Detailed Description:

Insomnia is characterized by difficulties initiating and maintaining sleep or of nonrestorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.

Ramelteon is a selective melatonin-1 receptor agonist under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.

This study will determine the safety and efficacy of 35-day treatment of chronic insomnia with Ramelteon using polysomnography and subjective measures of sleep. Participation in this study is anticipated to be about 2 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind Placebo-Controlled, PSG Plus Outpatient Study to Determine the Safety and Efficacy of TAK-375 in Adults With Chronic Insomnia
Study Start Date : January 2003
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Ramelteon

Arm Intervention/treatment
Experimental: Ramelteon 8 mg QD Drug: Ramelteon
Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.
Other Names:
  • Rozerem™
  • TAK-375

Experimental: Ramelteon 16 mg QD Drug: Ramelteon
Ramelteon 16 mg, tablets, orally, once nightly for up to 5 weeks.
Other Names:
  • Rozerem™
  • TAK-375

Placebo Comparator: Placebo Drug: Placebo
Ramelteon placebo-matching tablets, orally, once nightly for up to 5 weeks.




Primary Outcome Measures :
  1. Mean Latency to Persistent Sleep. [ Time Frame: Week 1 ]

Secondary Outcome Measures :
  1. Mean Latency to Persistent Sleep. [ Time Frame: Weeks 3 and 5 or Final Visit ]
  2. Total Sleep Time. [ Time Frame: Weeks 1, 3 and 5 or Final Visit ]
  3. Sleep Efficiency. [ Time Frame: Weeks 1, 3 and 5 or Final Visit ]
  4. Awake Time after Persistent Sleep. [ Time Frame: Weeks 1, 3 and 5 or Final Visit ]
  5. Number of Awakenings after Persistent Sleep. [ Time Frame: Weeks 1, 3 and 5 or Final Visit ]
  6. Subjective Sleep Latency. [ Time Frame: Weeks 1, 3 and 5 or Final Visit ]
  7. Subjective Total Sleep Time. [ Time Frame: Weeks 1, 3 and 5 or Final Visit ]
  8. Subjective Sleep Quality. [ Time Frame: Weeks 1, 3 and 5 or Final Visit ]
  9. Subjective Awake Time. [ Time Frame: Weeks 1, 3 and 5 or Final Visit ]
  10. Subjective Number of Awakenings. [ Time Frame: Weeks 1, 3 and 5 or Final Visit ]
  11. Subjective Ease of Falling Back to Sleep. [ Time Frame: Weeks 1, 3 and 5 or Final Visit ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Females who are not of childbearing potential must be postmenopausal for 1 year or have history of hysterectomy and/or oophorectomy.
  • Primary insomnia as defined by the DSM-IV-TRTM for at least 3 months and as defined by subjective sleep latency (sSL) greater than or equal to 30 minutes, subjective total sleep time (sTST) less than or equal to 6.5 hours per night, and daytime complaint(s) associated with disturbed sleep.
  • Mean latency of greater than or equal to 20 minutes on 2 consecutive screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes screening nights with neither night less than 15 minutes. Also, a mean of 60 minutes of wake time during the 480 minutes in bed across two nights with no night less than 45 minutes.
  • Habitual bedtime is between 8:30 p.m. and 12:00 a.m.
  • Body mass index between 18 and 34, inclusive.

Exclusion Criteria

  • 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 the first night single-blind study medication, whichever is longer.
  • Sleep schedule changes required by employment (e.g. shift worker) within three months prior to the first night of single-blind 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 the first night of single blind study medication.
  • Ever had a history of seizures, sleep apnea, chronic obstructive pulmonary disease, 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 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 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 the first night of single-blind study medication.
  • Uses tobacco products during nightly awakenings.
  • Used melatonin, or other drugs or supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication.
  • Used any central nervous system medication within 1 week (or 5 half lives of the drug, whichever is longer) prior to the first day of single-blind study medication. These medications must not have been used to treat psychiatric disorders.
  • 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 each check-in.
  • Apnea hypopnea index (per hour of sleep) greater than 10 as seen on polysomnogram, on the first night of the polysomnogram screening.
  • Periodic leg movement with arousal index (per hour of sleep) greater than 10 as seen on polysomnogram, on the first night of polysomnogram screening.
  • 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 (including herbal preparations with central nervous system effects)
    • Narcotic analgesics
    • All beta blockers
    • Melatonin
    • St. John's Wort
    • Kavakava
    • Gingko biloba

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671125


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Scottsdale, Arizona, United States
United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
Anaheim, California, United States
Oakland, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Monica, California, United States
United States, Florida
Miami, Florida, United States
Pembroke Pines, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Kentucky
Crestview Hills, Kentucky, United States
United States, Maryland
Chevy Chase, Maryland, United States
United States, Massachusetts
Newton, Massachusetts, United States
United States, Michigan
Troy, Michigan, United States
United States, Nebraska
Lincoln, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
New York, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Lafayette Hill, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
Plano, Texas, United States
Sponsors and Collaborators
Takeda
Investigators
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Study Director: VP Clinical Science Takeda
Additional Information:
Publications of Results:
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00671125    
Other Study ID Numbers: 01-02-TL-375-021
U1111-1114-8329 ( Registry Identifier: WHO )
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: November 2012
Keywords provided by Takeda:
Sleep Disorder
Insomnia
Drug Therapy
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders