Clinical trial NCT00671567: Ramelteon in Adults With Chronic Insomnia
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Adults With Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Insomnia
Keywords: Sleep Disorder
Insomnia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-05-05
Enrollment: 848
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in adult subjects with chronic insomnia.

Detailed description: Insomnia is characterized by difficulties 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 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.

This study is designed to determine the safety and efficacy of 35-day treatment of chronic insomnia with Ramelteon, using subjective measures of sleep. Total subject participation time in this study is expected to be approximately 2 months.

Eligibility criteria: Inclusion Criteria

* 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.
* Has had primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Text Revision 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, based on subject diary.
* 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 taken 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 has substantially altered their 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 (including anxiety or depression) 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.
* 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 the first day of single-blind 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 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 that may interfere with evaluation of the study medication, including:

  * melatonin or other drugs or supplements known to affect sleep/wake function.
  * anxiolytics
  * hypnotics
  * antidepressants
  * anticonvulsants
  * sedating H1 antihistamines
  * systemic steroids
  * respiratory stimulants and decongestants
  * over-the-counter and prescription stimulants
  * over-the-counter and prescription diet aids
  * central nervous system active drugs (including herbal preparations with central nervous system effects)
  * narcotic analgesics
  * beta blockers
  * melatonin
  * St. John's Wort
  * kava-kava
  * gingko biloba

Primary outcomes:
measure: Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind treatment.
timeFrame: Weeks 1, 2, 3, 4, and 5 or Final Visit
Secondary outcomes:
measure: Mean Subjective Sleep Latency per subject diary, over the week preceding the Day 15, Day 22, Day 29, and Day 36 Visits.
timeFrame: Weeks 2, 3, 4, and 5 or Final Visit
measure: Subjective Total Sleep Time
timeFrame: Weeks 1, 2, 3, 4, and 5 or Final Visit
measure: Subjective Number of Awakenings.
timeFrame: Weeks 1, 2, 3, 4, and 5 or Final Visit
measure: Subjective Ease of Falling Back to Sleep after Awakening.
timeFrame: Weeks 1, 2, 3, 4, and 5 or Final Visit
measure: Subjective Sleep Quality.
timeFrame: Weeks 1, 2, 3, 4, and 5 or Final Visit
measure: Clinician's Clinical Global Impression
timeFrame: Weeks 1, 2, 3, 4, and 5 or Final Visit
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Phoenix
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state: Arizona
city: Scottsdale
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state: Arizona
city: Tempe
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state: Arizona
city: Hot Springs
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state: Arkansas
city: Little Rock
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state: Arkansas
city: Anaheim
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Irvine
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state: California
city: La Mesa
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Northridge
country: United States
state: California
city: Oakland
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state: California
city: Redlands
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state: California
city: Spring Valley
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state: California
city: Colorado Springs
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state: Colorado
city: Denver
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: Hollywood
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state: Florida
city: Jacksonville
country: United States
state: Florida
city: Longwood
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Safety Harbor
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Blairsville
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Arlington Heights
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Danville
country: United States
state: Indiana
city: Evansville
country: United States
state: Indiana
city: Shawnee Mission
country: United States
state: Kansas
city: Bethesda
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Hattiesburg
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Lawrenceville
country: United States
state: New Jersey
city: Moorestown
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Mineola
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Beachwood
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Altoona
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Mt. Pleasant
country: United States
state: South Carolina
city: Johnson City
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Gig Harbor
country: United States
state: Washington
Study officials:
affiliation: Takeda
name: VP, Clinical Science
role: STUDY_DIRECTOR
References: