Efficacy of Ramelteon in Subjects With Chronic Insomnia

NCT00671086 | Completed Phase 3

• 2 other identifiers: 01-02-TL-375-022U1111-1114-3372
• Study Type: interventional
• Target: 1,213
• Locations: 1 country
• Sites: 122

Brief Summary

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

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Chronic Insomnia; DIMS (Disorders of Initiating and Maintaining Sleep); Disorders of Initiating and Maintaining Sleep; Insomnia Disorder Sleep Initiation Dysfunction; Transient Insomnia; Drug Therapy; Sleep Disorders, Intrinsic

Outcome Measures

Primary Outcomes (8)

• Adverse Events.

  Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit.

• Change from Baseline in Vital Signs.

  Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit

• Change from Baseline in Hematology Laboratory Tests.

  Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.

• Change from Baseline in Chemistry Laboratory Tests.

  Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.

• Change from Baseline in Urinalysis Laboratory Tests.

  Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.

• Electrocardiograms.

  Month 6 and 12 or Final Visit.

• Menstrual Diary Results.

  Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.

• Physical Examinations.

  Months 2, 4, 8, 10, and 12 or Final Visit.

Secondary Outcomes (3)

• Change from Baseline in Subjective Total Sleep Time.

  Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.

• Change from Baseline in Subjective Sleep Latency.

  Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.

• Clinical Global Impression Scale.

  Months 6 and 12 or Final Visit.

Study Arms (2)

Ramelteon 8 mg QD

EXPERIMENTAL

Drug: Ramelteon

Ramelteon 16 mg QD

EXPERIMENTAL

Drug: Ramelteon

Interventions

Ramelteon DRUG

Subjects 65 yrs of age and older will take Ramelteon 8 mg, tablets, orally, once nightly for up to one year.

Also known as: Rozerem, TAK-375

Ramelteon 8 mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (122)

Unknown Facility

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Burbank, California, United States

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Cerritos, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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La Mesa, California, United States

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Lafayette, California, United States

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Murrieta, California, United States

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Newport Beach, California, United States

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Northridge, California, United States

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Redlands, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Monica, California, United States

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Boulder, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Pueblo, Colorado, United States

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Wheat Ridge, Colorado, United States

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Wilmington, Delaware, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Edgewater, Florida, United States

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Fort Lauderdale, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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New Smyrna Beach, Florida, United States

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Ocala, Florida, United States

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Safety Harbor, Florida, United States

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St. Petersburg, Florida, United States

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Stuart, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Austell, Georgia, United States

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Blairsville, Georgia, United States

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Macon, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Elk Grove Village, Illinois, United States

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Libertyville, Illinois, United States

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Skokie, Illinois, United States

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Evansville, Indiana, United States

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Fort Wayne, Indiana, United States

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Shawnee Mission, Kansas, United States

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Florence, Kentucky, United States

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Louisville, Kentucky, United States

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Paducah, Kentucky, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Bryan Pogue, Maryland, United States

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Chevy Chase, Maryland, United States

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Frederick, Maryland, United States

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Prince Frederick, Maryland, United States

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Rockville, Maryland, United States

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Newton, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Troy, Michigan, United States

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Minneapolis, Minnesota, United States

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Hattiesburg, Mississippi, United States

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City of Saint Peters, Missouri, United States

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St Louis, Missouri, United States

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Wentzville, Missouri, United States

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Billings, Montana, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Clementon, New Jersey, United States

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Lawrenceville, New Jersey, United States

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Newark, New Jersey, United States

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Toma River, New Jersey, United States

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Brooklyn, New York, United States

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Kingston, New York, United States

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Lake Success, New York, United States

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Rochester, New York, United States

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White Plains, New York, United States

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Williamsville, New York, United States

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Cary, North Carolina, United States

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Raleigh, North Carolina, United States

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Salisbury, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dublin, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Lafayette Hill, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina, United States

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Columbia, South Carolina, United States

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Greer, South Carolina, United States

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Bristol, Tennessee, United States

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Cordova, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Oakland, Washington, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Wauwatosa, Wisconsin, United States

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Related Publications (1)

• Richardson GS, Zammit G, Wang-Weigand S, Zhang J. Safety and subjective sleep effects of ramelteon administration in adults and older adults with chronic primary insomnia: a 1-year, open-label study. J Clin Psychiatry. 2009 Apr;70(4):467-76. doi: 10.4088/jcp.07m03834. Epub 2009 Mar 10.

  PMID: 19284927 RESULT

Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• VP Clinical Science

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: February 1, 2003
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (122)