Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Sleep Disorders, Circadian Rhythm

In brief

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.

Key facts

Study ID

NCT00593736

Run by

Takeda

People needed

132

Starts

2007-10-01

Expected to finish

2008-05-01

Last updated by the study team

2012-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Must have discontinued use of all pharmacological sleep aids beginning 1 week prior to Visit 2 and for the duration of the trial.

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.
• Routinely consumes caffeine including coffee, tea and/or other caffeine-containing beverages or food averaging more than 600 mg of caffeine per day.
• Has used any central nervous system drug or other medications, including those used to treat psychiatric disorders, known to affect sleep/wake function within 1 week whichever is longer prior to the administration of single blind study drug.
• Used melatonin, or other drugs/supplements known to affect sleep/wake function within 1 week (or 5 half lives of the drug) whichever is longer prior to the first dose of single blind medication.
• Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• Anxiolytics
• Hypnotics
• Antidepressants
• Anticonvulsants
• Sedating H1 antihistamines
• Systemic steroids

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Fountain Valley, California, United States
• Study site — Glendale, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Monica, California, United States
• Study site — Tustin, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Hallandale Bch, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Spring Hill, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Gainesville, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Danville, Indiana, United States
• Study site — Overland Park, Kansas, United States
• Study site — Topeka, Kansas, United States

Full record on ClinicalTrials.gov

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