Efficacy of Ramelteon in Subjects With Chronic Insomnia

NCT ID: NCT00671086

Last Updated: 2012-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2004-09-30

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 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 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.

The purpose of this study is to obtain data in support the safety of long-term use of Ramelteon for insomnia, and to determine whether there are any adverse effects associated with extended use. Participation in this study is expected to be about. Participation in this study is anticipated to be approximately 13 months.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ramelteon 8 mg QD

Group Type: EXPERIMENTAL

Ramelteon

Intervention Type: DRUG

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

Ramelteon 16 mg QD

Group Type: EXPERIMENTAL

Ramelteon

Intervention Type: DRUG

Subjects between 18 and 64 years of age will take Ramelteon 16 mg, tablets, orally, once nightly for up to one year.

Interventions

Ramelteon

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

Intervention Type: DRUG

Ramelteon

Subjects between 18 and 64 years of age will take Ramelteon 16 mg, tablets, orally, once nightly for up to one year.

Intervention Type: DRUG

Other Intervention Names

Rozerem; TAK-375; Rozerem; TAK-375

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

VP Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

Birmingham, Alabama, United States

Mobile, Alabama, United States

Phoenix, Arizona, United States

Tempe, Arizona, United States

Hot Springs, Arkansas, United States

Little Rock, Arkansas, United States

Anaheim, California, United States

Burbank, California, United States

Cerritos, California, United States

Irvine, California, United States

La Jolla, California, United States

La Mesa, California, United States

Lafayette, California, United States

Murrieta, California, United States

Newport Beach, California, United States

Northridge, California, United States

Redlands, California, United States

Riverside, California, United States

San Diego, California, United States

San Francisco, California, United States

Santa Monica, California, United States

Boulder, Colorado, United States

Colorado Springs, Colorado, United States

Denver, Colorado, United States

Pueblo, Colorado, United States

Wheat Ridge, Colorado, United States

Wilmington, Delaware, United States

Brandon, Florida, United States

Clearwater, Florida, United States

DeLand, Florida, United States

Edgewater, Florida, United States

Fort Lauderdale, Florida, United States

Largo, Florida, United States

Miami, Florida, United States

Naples, Florida, United States

New Smyrna Beach, Florida, United States

Ocala, Florida, United States

Safety Harbor, Florida, United States

St. Petersburg, Florida, United States

Stuart, Florida, United States

Tampa, Florida, United States

Winter Park, Florida, United States

Atlanta, Georgia, United States

Austell, Georgia, United States

Blairsville, Georgia, United States

Macon, Georgia, United States

Boise, Idaho, United States

Chicago, Illinois, United States

Elk Grove Village, Illinois, United States

Libertyville, Illinois, United States

Skokie, Illinois, United States

Evansville, Indiana, United States

Fort Wayne, Indiana, United States

Shawnee Mission, Kansas, United States

Florence, Kentucky, United States

Louisville, Kentucky, United States

Paducah, Kentucky, United States

New Orleans, Louisiana, United States

Shreveport, Louisiana, United States

Baltimore, Maryland, United States

Bryan Pogue, Maryland, United States

Chevy Chase, Maryland, United States

Frederick, Maryland, United States

Prince Frederick, Maryland, United States

Rockville, Maryland, United States

Newton, Massachusetts, United States

Ann Arbor, Michigan, United States

Troy, Michigan, United States

Minneapolis, Minnesota, United States

Hattiesburg, Mississippi, United States

City of Saint Peters, Missouri, United States

St Louis, Missouri, United States

Wentzville, Missouri, United States

Billings, Montana, United States

Lincoln, Nebraska, United States

Las Vegas, Nevada, United States

Clementon, New Jersey, United States

Lawrenceville, New Jersey, United States

Newark, New Jersey, United States

Toma River, New Jersey, United States

Brooklyn, New York, United States

Kingston, New York, United States

Lake Success, New York, United States

Rochester, New York, United States

White Plains, New York, United States

Williamsville, New York, United States

Cary, North Carolina, United States

Raleigh, North Carolina, United States

Salisbury, North Carolina, United States

Wilmington, North Carolina, United States

Winston-Salem, North Carolina, United States

Beachwood, Ohio, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Dublin, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Eugene, Oregon, United States

Portland, Oregon, United States

Bala-Cynwyd, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Jenkintown, Pennsylvania, United States

Lafayette Hill, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Warwick, Rhode Island, United States

Anderson, South Carolina, United States

Columbia, South Carolina, United States

Greer, South Carolina, United States

Bristol, Tennessee, United States

Cordova, Tennessee, United States

Austin, Texas, United States

Houston, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Charlottesville, Virginia, United States

Fairfax, Virginia, United States

Oakland, Washington, United States

Seattle, Washington, United States

Tacoma, Washington, United States

Milwaukee, Wisconsin, United States

Wauwatosa, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19284927 (View on PubMed)

Related Links

http://general.takedapharm.com/content/file/pi.pdf?applicationcode=ab2d7112-8eb3-465a-8fda-35018a9eafb0&fileTypeCode=ROZEREMPI

Rozerem Package Insert

Other Identifiers

U1111-1114-3372

Identifier Type: REGISTRY

Identifier Source: secondary_id

01-02-TL-375-022

Identifier Type: -

Identifier Source: org_study_id