Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome
A Randomized, Double-Blind, Placebo-Controlled, Parallel, Proof of Concept Study to Evaluate the Effectiveness of Ramelteon to Advance the Timing of Sleep in Individuals With Delayed Sleep Phase Syndrome (DSPS)
1 other identifier
interventional
132
1 country
42
Brief Summary
The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
Shorter than P25 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 2, 2008
CompletedFirst Posted
Study publicly available on registry
January 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
March 9, 2010
CompletedFebruary 28, 2012
February 1, 2012
7 months
January 2, 2008
July 31, 2009
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)
The elapsed time from the beginning of the polysomnography recording to the onset of the first 10 minutes of continuous sleep (ie, total number of epochs before the first 20 consecutive non-wake epochs divided by 2).
Nights 6-7
Secondary Outcomes (59)
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Nights 13-14
Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7)
Nights 6-7
Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14)
Nights 13-14
Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7)
Nights 6-7
Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 13-14)
Nights 13-14
- +54 more secondary outcomes
Study Arms (4)
Ramelteon 1 mg QD
EXPERIMENTALRamelteon 4 mg QD
EXPERIMENTALRamelteon 8 mg QD
EXPERIMENTALPlacebo QD
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Females of childbearing potential who is sexually active must agree to use adequate contraception from screening throughout the duration of the study.
- Must have a diagnosis of Delayed Sleep Phase Syndrome according to International Classification of Sleep Disorders criteria for at least 3 months.
- Based on sleep history, subject's habitual sleep time is more than 3 hours later than the desired sleep time.
- Must have had self reported insomnia which is defined per the sleep history as his or her sleep latency of at least 45 minutes when attempting to sleep at desired sleep time required by his or her work or school schedule.
- The subjective sleep latency via Post sleep questionnaire during outpatient screening period must be greater than or equal to 45 minutes during every working night or school night provided the subject went to bed at their desired sleep time.
- During single blind placebo run-in Polysomnography screening nights, subject is instructed to go to bed at their desired bed time and must demonstrate difficulty in falling asleep based on the following criteria:
- During Polysomnography screening nights when the subject goes to bed at their desired sleep time or
- The average of total wake time
- Is in good health as determined by a medical and psychiatric history, physical examination, Electrocardiogram, and serum chemistry and hematology.
- Is able to complete self-rating scales via interactive voice response system, and has a touch tone phone.
- Is willing to comply with study procedures and restrictions with fixed sleep time and wake time during the study and to attend regularly scheduled clinic visits as specified in this protocol.
- Has a body mass index is between 18 and 34 kg/m2, inclusive.
- Has a negative urine test result for selected substances of abuse (including alcohol).
- Has a negative test result for hepatitis B surface antigen and hepatitis C virus antibody or history of human immunodeficiency virus.
- Has not used pharmacological sleep assistance for more than 4 times/week during the 3 months prior to Initial Screening.
- +1 more criteria
You may not qualify if:
- Has a known hypersensitivity to ramelteon or related compounds, including melatonin and melatonin-related compounds or 5-hydroxytryptophan.
- Has participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives prior to the first dose of study medication, whichever is longer.
- Has flown across greater than 3 time zones within the past 3 months prior to administration of study medication.
- Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of study medication.
- Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of study medication.
- Has a history of alcohol abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, or regularly consumes more than 14 alcoholic drinks per week or consumes any alcoholic drinks within 24 hours of Screening Visit.
- Has a history of drug abuse within the past 12 months.
- Has a current, clinically significant neurological (including cognitive), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator.
- Has a probable current diagnosis of another circadian rhythm disorder or a sleep disorder other than Delayed Sleep Phase Syndrome that is the primary cause of insomnia.
- Had an apnea hypopnea index greater than 10 on the first night of Polysomnography Screening.
- Has periodic limb movements during sleep with arousal index greater than 10 as seen on the first night of Polysomnography screening only.
- Has a positive urine drug screen or breathalyzer test.
- Has ever had a history of seizures; sleep apnea, restless leg syndrome, chronic obstructive pulmonary disease, fibromyalgia, or a positive test result for the aforementioned ailments on the screening Polysomnography, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.
- Has a history of psychiatric disorder (including anxiety or depression) within the past 12 months.
- Smokes more than 3 cigarettes per day or uses tobacco products during nightly awakenings.
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (42)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Fountain Valley, California, United States
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Glendale, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Tustin, California, United States
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Colorado Springs, Colorado, United States
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Hallandale Bch, Florida, United States
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Naples, Florida, United States
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Pembroke Pines, Florida, United States
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South Miami, Florida, United States
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Spring Hill, Florida, United States
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St. Petersburg, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Gainesville, Georgia, United States
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Macon, Georgia, United States
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Chicago, Illinois, United States
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Danville, Indiana, United States
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Overland Park, Kansas, United States
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Topeka, Kansas, United States
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Crestview Hills, Kentucky, United States
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Paducah, Kentucky, United States
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Chevy Chase, Maryland, United States
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Newton, Massachusetts, United States
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Hattiesburg, Mississippi, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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New York, New York, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Cincinnati, Ohio, United States
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Dublin, Ohio, United States
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Toledo, Ohio, United States
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Salem, Oregon, United States
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Clarks Summit, Pennsylvania, United States
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Columbia, South Carolina, United States
Unknown Facility
Austin, Texas, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2008
First Posted
January 15, 2008
Study Start
October 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
February 28, 2012
Results First Posted
March 9, 2010
Record last verified: 2012-02