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Efficacy of Ramelteon in Subjects With Chronic Insomnia

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT00671086
Collaborator
(none)
1,213
Enrollment
122
Locations
2
Arms
19
Duration (Months)
9.9
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the long-term safety of Ramelteon, once daily (QD), in subjects with chronic insomnia.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1213 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open-label, Fixed-dose Study to Determine the Safety of Long-term Administration of TAK-375 in Subjects With Chronic Insomnia
Study Start Date :
Feb 1, 2003
Actual Primary Completion Date :
Sep 1, 2004
Actual Study Completion Date :
Sep 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ramelteon 8 mg QD

Drug: Ramelteon
Subjects 65 yrs of age and older will take Ramelteon 8 mg, tablets, orally, once nightly for up to one year.
Other Names:
  • Rozerem
  • TAK-375

    		•
    Experimental: Ramelteon 16 mg QD

    Drug: Ramelteon
    Subjects between 18 and 64 years of age will take Ramelteon 16 mg, tablets, orally, once nightly for up to one year.
    Other Names:
  • Rozerem
  • TAK-375

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events. [Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit.]

    2. Change from Baseline in Vital Signs. [Week 1, Months 1, 2, 3, 4, 6, 8, 10, and 12 or Final Visit]

    3. Change from Baseline in Hematology Laboratory Tests. [Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.]

    4. Change from Baseline in Chemistry Laboratory Tests. [Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.]

    5. Change from Baseline in Urinalysis Laboratory Tests. [Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.]

    6. Electrocardiograms. [Month 6 and 12 or Final Visit.]

    7. Menstrual Diary Results. [Week 1, Months 1, 2, 4, 6, 8, 10, and 12 or Final Visit.]

    8. Physical Examinations. [Months 2, 4, 8, 10, and 12 or Final Visit.]

    Secondary Outcome Measures

    1. Change from Baseline in Subjective Total Sleep Time. [Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.]

    2. Change from Baseline in Subjective Sleep Latency. [Week 1, Months 1, 2, 3, 4, 6, 8, 10, 12, and 12 or Final Visit.]

    3. Clinical Global Impression Scale. [Months 6 and 12 or Final Visit.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States
    2 Mobile Alabama United States
    3 Phoenix Arizona United States
    4 Tempe Arizona United States
    5 Hot Springs Arkansas United States
    6 Little Rock Arkansas United States
    7 Anaheim California United States
    8 Burbank California United States
    9 Cerritos California United States
    10 Irvine California United States
    11 La Jolla California United States
    12 La Mesa California United States
    13 Lafayette California United States
    14 Murrieta California United States
    15 Newport Beach California United States
    16 Northridge California United States
    17 Redlands California United States
    18 Riverside California United States
    19 San Diego California United States
    20 San Francisco California United States
    21 Santa Monica California United States
    22 Boulder Colorado United States
    23 Colorado Springs Colorado United States
    24 Denver Colorado United States
    25 Pueblo Colorado United States
    26 Wheat Ridge Colorado United States
    27 Wilmington Delaware United States
    28 Brandon Florida United States
    29 Clearwater Florida United States
    30 Deland Florida United States
    31 Edgewater Florida United States
    32 Fort Lauderdale Florida United States
    33 Largo Florida United States
    34 Miami Florida United States
    35 Naples Florida United States
    36 New Smyrna Beach Florida United States
    37 Ocala Florida United States
    38 Safety Harbor Florida United States
    39 St. Petersburg Florida United States
    40 Stuart Florida United States
    41 Tampa Florida United States
    42 Winter Park Florida United States
    43 Atlanta Georgia United States
    44 Austell Georgia United States
    45 Blairsville Georgia United States
    46 Macon Georgia United States
    47 Boise Idaho United States
    48 Chicago Illinois United States
    49 Elk Grove Village Illinois United States
    50 Libertyville Illinois United States
    51 Skokie Illinois United States
    52 Evansville Indiana United States
    53 Fort Wayne Indiana United States
    54 Shawnee Mission Kansas United States
    55 Florence Kentucky United States
    56 Louisville Kentucky United States
    57 Paducah Kentucky United States
    58 New Orleans Louisiana United States
    59 Shreveport Louisiana United States
    60 Baltimore Maryland United States
    61 Bryan Pogue Maryland United States
    62 Chevy Chase Maryland United States
    63 Frederick Maryland United States
    64 Prince Frederick Maryland United States
    65 Rockville Maryland United States
    66 Newton Massachusetts United States
    67 Ann Arbor Michigan United States
    68 Troy Michigan United States
    69 Minneapolis Minnesota United States
    70 Hattiesburg Mississippi United States
    71 St. Louis Missouri United States
    72 St. Peters Missouri United States
    73 Wentzville Missouri United States
    74 Billings Montana United States
    75 Lincoln Nebraska United States
    76 Las Vegas Nevada United States
    77 Clementon New Jersey United States
    78 Lawrenceville New Jersey United States
    79 Newark New Jersey United States
    80 Toma River New Jersey United States
    81 Brooklyn New York United States
    82 Kingston New York United States
    83 Lake Success New York United States
    84 Rochester New York United States
    85 White Plains New York United States
    86 Williamsville New York United States
    87 Cary North Carolina United States
    88 Raleigh North Carolina United States
    89 Salisbury North Carolina United States
    90 Wilmington North Carolina United States
    91 Winston-Salem North Carolina United States
    92 Beachwood Ohio United States
    93 Cincinnati Ohio United States
    94 Columbus Ohio United States
    95 Dublin Ohio United States
    96 Toledo Ohio United States
    97 Oklahoma City Oklahoma United States
    98 Eugene Oregon United States
    99 Portland Oregon United States
    100 Bala Cynwyd Pennsylvania United States
    101 Duncansville Pennsylvania United States
    102 Jenkintown Pennsylvania United States
    103 Lafayette Hill Pennsylvania United States
    104 Philadelphia Pennsylvania United States
    105 Warwick Rhode Island United States
    106 Anderson South Carolina United States
    107 Columbia South Carolina United States
    108 Greer South Carolina United States
    109 Bristol Tennessee United States
    110 Cordova Tennessee United States
    111 Austin Texas United States
    112 Houston Texas United States
    113 Plano Texas United States
    114 San Antonio Texas United States
    115 Salt Lake City Utah United States
    116 Charlottesville Virginia United States
    117 Fairfax Virginia United States
    118 Oakland Washington United States
    119 Seattle Washington United States
    120 Tacoma Washington United States
    121 Milwaukee Wisconsin United States
    122 Wauwatosa Wisconsin United States

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: VP Clinical Science, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT00671086
    Other Study ID Numbers:
    • 01-02-TL-375-022
    • U1111-1114-3372
    First Posted:
    May 5, 2008
    Last Update Posted:
    Feb 28, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by Takeda
    Chronic Insomnia
    DIMS (Disorders of Initiating and Maintaining Sleep)
    Disorders of Initiating and Maintaining Sleep
    Insomnia Disorder Sleep Initiation Dysfunction
    Transient Insomnia
    Drug Therapy
    Sleep Disorders, Intrinsic
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders

    Study Results

    No Results Posted as of Feb 28, 2012