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Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671255
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : February 28, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Drug: Ramelteon Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 829 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Elderly Subjects With Chronic Insomnia
Study Start Date : December 2002
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Ramelteon

Arm Intervention/treatment
Experimental: Ramelteon 4 mg QD Drug: Ramelteon
Ramelteon 4 mg, tablets, orally, once daily for up to 5 weeks.
Other Names:
  • Rozerem™
  • TAK-375

Experimental: Ramelteon 8 mg QD Drug: Ramelteon
Ramelteon 8 mg, tablets, orally, once daily for up to 5 weeks.
Other Names:
  • Rozerem™
  • TAK-375

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

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Subjective Total Sleep Time. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
  2. Subjective Number of Awakenings. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
  3. Subjective Ease of Falling Back to Sleep after Awakening. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
  4. Subjective Sleep Quality. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
  5. Clinical Global Impression Change of Condition. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
  6. Clinical Global Impression Severity of Illness. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
  7. Clinical Global Impression Therapeutic Effect. [ Time Frame: Weeks 1, 2, 3, 4 and 5 or Final Visit. ]
  8. Clinical Global Impression Side Effects. [ Time Frame: 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. [ Time Frame: Weeks 2, 3, 4 and 5 or Final Visit. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00671255

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Sponsors and Collaborators
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Study Director: VP Clinical Science Takeda
Additional Information:
Publications of Results:
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Responsible Party: Takeda Identifier: NCT00671255    
Other Study ID Numbers: 01-02-TL-375-025
U1111-1114-1190 ( Registry Identifier: WHO )
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012
Keywords provided by Takeda:
Chronic Insomnia
Drug Therapy
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders