Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

NCT ID: NCT00671255

Last Updated: 2012-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 829 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2004-01-31

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.

Detailed Description

Insomnia is characterized by a complaint of initiating and maintaining sleep or complaints 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 development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.

Ramelteon is the first candidate in a novel class of drugs based on this mechanism. Based on non-clinical and clinical studies completed to date, TAK-375 has the potential to offer unique advantages relative to approved hypnotics in terms of its pharmacological profile and its selectivity to the melatonin-1 receptor.

This study is designed to determine the safety and efficacy of 35-day treatment of chronic insomnia with ramelteon. Participation in this study is anticipated to be approximately 2 months.

Conditions

Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ramelteon 4 mg QD

Group Type: EXPERIMENTAL

Ramelteon

Intervention Type: DRUG

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

Ramelteon 8 mg QD

Group Type: EXPERIMENTAL

Ramelteon

Intervention Type: DRUG

Ramelteon 8 mg, tablets, orally, once daily for up to 5 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Ramelteon

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

Intervention Type: DRUG

Ramelteon

Ramelteon 8 mg, tablets, orally, once daily for up to 5 weeks.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Rozerem™; TAK-375; Rozerem™; TAK-375

Eligibility Criteria

Inclusion Criteria

• 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.

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 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
• 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
• Decongestants
• Over-the-counter and prescription stimulants
• Over-the-counter and prescription diet aids
• Central nervous system active drugs
• Narcotic analgesics
• All beta blockers
• Melatonin
• St. John's Wort
• Kava-kava
• Gingko biloba

• Minimum Eligible Age: 65 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

Columbiana, Alabama, United States

Mobile, Alabama, United States

Muscle Shoals, Alabama, United States

Tallahassee, Alabama, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Tempe, Arizona, United States

Hot Springs, Arkansas, United States

Little Rock, Arkansas, United States

Anaheim, California, United States

Encinitas, California, United States

Irvine, California, United States

La Jolla, California, United States

La Mesa, California, United States

Los Angeles, California, United States

Murrieta, California, United States

Northridge, California, United States

Oakland, California, United States

Redlands, California, United States

Riverside, California, United States

Rosemead, California, United States

San Diego, California, United States

Spring Valley, California, United States

Vista, California, United States

Colorado Springs, Colorado, United States

Denver, Colorado, United States

Clearwater, Florida, United States

DeLand, Florida, United States

Hollywood, Florida, United States

Jacksonville, Florida, United States

Kissimmee, Florida, United States

Longwood, Florida, United States

Pembroke Pines, Florida, United States

Pinellas Park, Florida, United States

Safety Harbor, Florida, United States

St. Petersburg, Florida, United States

Tampa, Florida, United States

Vero Beach, Florida, United States

West Palm Beach, Florida, United States

Winter Park, Florida, United States

Atlanta, Georgia, United States

Blairsville, Georgia, United States

Macon, Georgia, United States

Chciago, Illinois, United States

Northfield, Illinois, United States

Evansville, Indiana, United States

Shawnee Mission, Kansas, United States

Wichita, Kansas, United States

Louisville, Kentucky, United States

Murray, Kentucky, United States

New Orleans, Louisiana, United States

Bethesda, Maryland, United States

Belmont, Massachusetts, United States

Brockton, Massachusetts, United States

Newton, Massachusetts, United States

Detroit, Michigan, United States

Hattiesburg, Mississippi, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Lincoln, Nebraska, United States

Las Vegas, Nevada, United States

Brick, New Jersey, United States

Edison, New Jersey, United States

Toms River, New Jersey, United States

Albuquerque, New Mexico, United States

Great Neck, New York, United States

Manlius, New York, United States

Mineola, New York, United States

Williamsville, New York, United States

Cary, North Carolina, United States

Greensboro, North Carolina, United States

Hickory, North Carolina, United States

Raleigh, North Carolina, United States

Salisbury, North Carolina, United States

Winston-Salem, North Carolina, United States

Beachwood, Ohio, United States

Canfield, Ohio, United States

Cincinnati, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Eugene, Oregon, United States

Portland, Oregon, United States

Jenkintown, Pennsylvania, United States

Reading, Pennsylvania, United States

Scotland, Pennsylvania, United States

Warwick, Rhode Island, United States

Anderson, South Carolina, United States

Greer, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Fayetteville, Tennessee, United States

Johnson City, Tennessee, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Norfolk, Virginia, United States

Bellevue, Washington, United States

Gig Harbor, Washington, United States

Madison, Wisconsin, United States

New Berlin, Wisconsin, United States

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Medicine Hat, Alberta, Canada

North Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

St. John's, Newfoundland and Labrador, Canada

Corunna, Ontario, Canada

London, Ontario, Canada

North Bay, Ontario, Canada

Sarnia, Ontario, Canada

Toronto, Ontario, Canada

Parkdale, Prince Edward Island, Canada

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 17996657 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16709464 (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

U1111-1114-1190

Identifier Type: REGISTRY

Identifier Source: secondary_id

01-02-TL-375-025

Identifier Type: -

Identifier Source: org_study_id