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Chronic InsomniaPhase 3NCT00671255

Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

A Phase 3 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 115 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 65 years and older
Conditions the study is for
Chronic Insomnia
What is being tested?
Ramelteon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
829 participants
Where
115 sitesin 2 countries
Study dates
Dec 2002to Jan 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 35Show fewer
  • 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

Trial locations and contacts

115 sites in 2 countries.

115 sites in 2 countries

United States102 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Beachwood, Ohio

  • Study site

    Bellevue, Washington

  • Study site

    Belmont, Massachusetts

  • Study site

    Bethesda, Maryland

  • Study site

    Blairsville, Georgia

  • Study site

    Brick, New Jersey

  • Study site

    Brockton, Massachusetts

  • Study site

    Canfield, Ohio

  • Study site

    Cary, North Carolina

  • Study site

    Chciago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbiana, Alabama

  • Study site

    Dallas, Texas

  • Study site

    DeLand, Florida

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Edison, New Jersey

  • Study site

    Encinitas, California

  • Study site

    Eugene, Oregon

  • Study site

    Evansville, Indiana

  • Study site

    Fayetteville, Tennessee

  • Study site

    Fort Worth, Texas

  • Study site

    Gig Harbor, Washington

  • Study site

    Great Neck, New York

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Hattiesburg, Mississippi

  • Study site

    Hickory, North Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Hot Springs, Arkansas

  • Study site

    Houston, Texas

  • Study site

    Irvine, California

  • Study site

    Jacksonville, Florida

  • Study site

    Jenkintown, Pennsylvania

  • Study site

    Johnson City, Tennessee

  • Study site

    Kansas City, Missouri

  • Study site

    Kissimmee, Florida

  • Study site

    La Jolla, California

  • Study site

    La Mesa, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Longwood, Florida

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Macon, Georgia

  • Study site

    Madison, Wisconsin

  • Study site

    Manlius, New York

  • Study site

    Mineola, New York

  • Study site

    Mobile, Alabama

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Murray, Kentucky

  • Study site

    Murrieta, California

  • Study site

    Muscle Shoals, Alabama

  • Study site

    New Berlin, Wisconsin

  • Study site

    New Orleans, Louisiana

  • Study site

    Newton, Massachusetts

  • Study site

    Norfolk, Virginia

  • Study site

    Northfield, Illinois

  • Study site

    Northridge, California

  • Study site

    Oakland, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Pembroke Pines, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Pinellas Park, Florida

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Reading, Pennsylvania

  • Study site

    Redlands, California

  • Study site

    Riverside, California

  • Study site

    Rosemead, California

  • Study site

    Safety Harbor, Florida

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Scotland, Pennsylvania

  • Study site

    Scottsdale, Arizona

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Spring Valley, California

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Tallahassee, Alabama

  • Study site

    Tampa, Florida

  • Study site

    Tempe, Arizona

  • Study site

    Toledo, Ohio

  • Study site

    Toms River, New Jersey

  • Study site

    Tulsa, Oklahoma

  • Study site

    Vero Beach, Florida

  • Study site

    Vista, California

  • Study site

    Warwick, Rhode Island

  • Study site

    West Palm Beach, Florida

  • Study site

    Wichita, Kansas

  • Study site

    Williamsville, New York

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Winter Park, Florida

Other trials in United States

Canada13 sites

  • Study site

    Calgary, Alberta

  • Study site

    Corunna, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    London, Ontario

  • Study site

    Medicine Hat, Alberta

  • Study site

    Montreal, Quebec

  • Study site

    North Bay, Ontario

  • Study site

    North Vancouver, British Columbia

  • Study site

    Parkdale, Prince Edward Island

  • Study site

    Sarnia, Ontario

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Elderly Subjects With Chronic Insomnia

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

Read the 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.

Being tested
Ramelteon, Placebo
Keywords
Chronic Insomnia, Drug Therapy, Elderly
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamelteonDrug

    Also called Rozerem™, TAK-375

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

  • RamelteonDrug

    Also called Rozerem™, TAK-375

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

  • PlaceboDrug

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

Study groups in NCT00671255
Study groupRoleWhat they receive
Ramelteon 4 mg QDExperimentalNot described
Receives: Drug: Ramelteon
Ramelteon 8 mg QDExperimentalNot described
Receives: Drug: Ramelteon
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (9)

  1. Subjective Total Sleep Time.

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

  2. Subjective Number of Awakenings.

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

  3. Subjective Ease of Falling Back to Sleep after Awakening.

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

  4. Subjective Sleep Quality.

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

  5. Clinical Global Impression Change of Condition.

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

  6. Clinical Global Impression Severity of Illness.

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

  7. Clinical Global Impression Therapeutic Effect.

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

  8. Clinical Global Impression Side Effects.

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

  9. Average Subjective Sleep Latency over the week preceding the Day 15, Day 22, Day 29, and Day 36 Visits.

    Measured: Weeks 2, 3, 4 and 5 or Final Visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2008 (estimated)
  2. Study startDec 2002
  3. Primary completionJan 2004
  4. Study completionJan 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
829 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00671255
Sponsor's protocol ID
01-02-TL-375-025
Other IDs
U1111-1114-1190
Status last verified
Feb 2012
First submitted
1 May 2008
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17996657

  • 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.

    PubMed 16709464

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramelteon in people with Chronic Insomnia, run by Takeda at 115 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind Treatment (time frame: Weeks 1, 2, 3, 4 and 5 or Final Visit.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00671255, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.

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