Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

NCT00671255 | Completed Phase 3

• 2 other identifiers: 01-02-TL-375-025U1111-1114-1190
• Study Type: interventional
• Target: 829
• Locations: 2 countries
• Sites: 115

Brief Summary

This purpose of this study is to evaluate the safety and effectiveness of Ramelteon, once daily (QD), in elderly participants with chronic insomnia.

Conditions

Chronic Insomnia

Keywords

Chronic Insomnia; Drug Therapy; Elderly

Outcome Measures

Primary Outcomes (1)

• Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind Treatment

  Weeks 1, 2, 3, 4 and 5 or Final Visit.

Secondary Outcomes (9)

• Subjective Total Sleep Time.

  Weeks 1, 2, 3, 4 and 5 or Final Visit.

• Subjective Number of Awakenings.

  Weeks 1, 2, 3, 4 and 5 or Final Visit.

• Subjective Ease of Falling Back to Sleep after Awakening.

  Weeks 1, 2, 3, 4 and 5 or Final Visit.

• Subjective Sleep Quality.

  Weeks 1, 2, 3, 4 and 5 or Final Visit.

• Clinical Global Impression Change of Condition.

  Weeks 1, 2, 3, 4 and 5 or Final Visit.

Study Arms (3)

Ramelteon 4 mg QD

EXPERIMENTAL

Drug: Ramelteon

Ramelteon 8 mg QD

EXPERIMENTAL

Drug: Ramelteon

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ramelteon DRUG

Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.

Also known as: Rozerem™, TAK-375

Ramelteon 4 mg QD

Placebo DRUG

Ramelteon placebo-matching, tablets, orally, each night for up to 35 consecutive days.

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject is a male or a post-menopausal female.
• 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 lead-in period.
• Habitual bedtime is between 8:30 PM and 12:00 AM.
• Body mass index between 18 and 34, inclusive.

You may not qualify if:

• Known hypersensitivity to ramelteon or related compounds, including melatonin.
• Previously participated in a study involving ramelteon.
• Participated in any other investigational study, and/or took any investigational drug within 30 days or five half-lives prior to the first day of single-blind study medication, whichever is longer.
• Sleep schedule changes required by employment (eg, shift worker) within three months prior to the first day 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 substantially altered exercise routine within 30 days prior to the first day of single blind study medication.
• Has 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 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 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.
• 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

Sponsors & Collaborators

• Takeda: lead

Study Sites (115)

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Columbiana, Alabama, United States

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Mobile, Alabama, United States

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Muscle Shoals, Alabama, United States

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Tallahassee, Alabama, United States

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Phoenix, Arizona, United States

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Scottsdale, 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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Encinitas, 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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Los Angeles, California, United States

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Murrieta, California, United States

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Northridge, California, United States

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Oakland, California, United States

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Redlands, California, United States

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Riverside, California, United States

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Rosemead, California, United States

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San Diego, California, United States

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Spring Valley, California, United States

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Vista, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Longwood, Florida, United States

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Pembroke Pines, Florida, United States

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Pinellas Park, 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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Tampa, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Blairsville, Georgia, United States

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Macon, Georgia, United States

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Chciago, Illinois, United States

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Northfield, Illinois, United States

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Evansville, Indiana, United States

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Shawnee Mission, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Murray, Kentucky, United States

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New Orleans, Louisiana, United States

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Bethesda, Maryland, United States

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Belmont, Massachusetts, United States

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Brockton, Massachusetts, United States

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Newton, Massachusetts, United States

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Detroit, Michigan, United States

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Hattiesburg, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Brick, New Jersey, United States

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Edison, New Jersey, United States

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Toms River, New Jersey, United States

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Albuquerque, New Mexico, United States

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Great Neck, New York, United States

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Manlius, New York, United States

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Mineola, 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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Greensboro, North Carolina, United States

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Hickory, 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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Winston-Salem, North Carolina, United States

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Beachwood, Ohio, United States

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Canfield, Ohio, United States

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Cincinnati, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Jenkintown, Pennsylvania, United States

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Reading, Pennsylvania, United States

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Scotland, 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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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Fayetteville, Tennessee, United States

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Johnson City, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, 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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Norfolk, Virginia, United States

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Bellevue, Washington, United States

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Gig Harbor, Washington, United States

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Madison, Wisconsin, United States

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New Berlin, Wisconsin, United States

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Medicine Hat, Alberta, Canada

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North Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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Corunna, Ontario, Canada

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London, Ontario, Canada

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North Bay, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Parkdale, Prince Edward Island, Canada

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Montreal, Quebec, Canada

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Related Publications (2)

• Mini LJ, Wang-Weigand S, Zhang J. Self-reported efficacy and tolerability of ramelteon 8 mg in older adults experiencing severe sleep-onset difficulty. Am J Geriatr Pharmacother. 2007 Sep;5(3):177-84. doi: 10.1016/j.amjopharm.2007.09.004.

  PMID: 17996657 RESULT

• Roth T, Seiden D, Sainati S, Wang-Weigand S, Zhang J, Zee P. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med. 2006 Jun;7(4):312-8. doi: 10.1016/j.sleep.2006.01.003. Epub 2006 May 18.

  PMID: 16709464 RESULT

Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; 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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: December 1, 2002
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (102); CA (13)