A Study to Evaluate the Effectiveness of Ramelteon to Advance the Timing of Sleep in Individuals With Delayed Sleep Phase Syndrome (DSPS)

Condition(s) targeted: Sleep Disorders, Circadian Rhythm

Intervention: TAK-375 (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Takeda Global Research & Development Center, Inc.

Official(s) and/or principal investigator(s):
Sherry Weigand, MD, PhD, Study Director, Affiliation: Takeda Global Research & Development Center, Inc.

Overall contact:
Shannon Zimmerman, RN, BSN, Phone: 224-554-6365, Email: szimmerman@tgrd.com

The purpose of this study is to evaluate the ability of ramelteon to advance the timing of sleep in individuals with delayed sleep phase syndrome (DSPS). The effect of ramelteon will be analyzed based on collection of information from a post-sleep questionnaire completed by the subject in an outpatient setting, and based on data collected by polysomnography in a sleep clinic setting.

Official title: 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)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Average latency to persistent sleep (LPS) as measured via polysomnography.

Secondary outcome:

Effects of ramelteon on objective and subjective sleep parameters.

Amelioration by ramelteon of other symptoms associated with DSPS.

Detailed description: The purpose of this study is to evaluate the ability of ramelteon, provided once daily over a period of 2 weeks, to advance the timing of sleep in individuals with delayed sleep phase syndrome (DSPS). The effect of ramelteon will be analyzed based on collection of information from a post-sleep questionnaire completed by the subject, and based on data collected by polysomnography in a sleep clinic setting. The total length of the study, including pretreatment, treatment, and follow-up, will be approximately 7 weeks.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The subject is male or female, aged 18 years or older.

- The subject has a diagnosis of delayed sleep phase syndrome according to International

Classification of Sleep Disorders criteria for at least 3 months.

- A female subject of childbearing potential agrees to use adequate contraception from

screening throughout the duration of the study.

- The subject's habitual sleep time is more than 3 hours later than the desired sleep

time.

- The subject is willing to comply with study procedures and restrictions with fixed

bedtime and wake time during the study, and to attend regularly scheduled clinic visits.

- The subject must have not used pharmacological sleep assistance more than 4 times/week

during the 3 months prior to Initial Screening, and must have discontinued use of all pharmacological sleep aids beginning 1 week prior to Visit 2 and for the duration of the trial.

Exclusion Criteria:

- The subject has a known hypersensitivity to ramelteon or related compounds, including

melatonin and melatonin-related compounds or 5-hydroxytryptophan.

- The subject has flown across more than 3 time zones within the 3 months prior to

administration of study medication.

- The subject has sleep schedule changes required by employment (eg, shift worker)

within 3 months prior to the administration of study medication.

- The subject has participated in a weight loss program or has substantially altered

their exercise routine within 30 days prior to the administration of study medication.

- The subject has a probably current diagnosis of another circadian rhythm disorder or a

sleep disorder other than DSPS that is th primary cause of insomnia.

- The subject smokes more than 3 cigarettes per day or uses tobacco products during

nightly awakenings.

Shannon Zimmerman, RN, BSN, Phone: 224-554-6365, Email: szimmerman@tgrd.com

Birmingham, Alabama, United States; Recruiting

Tucson, Arizona, United States; Recruiting

Hot Springs, Arkansas, United States; Recruiting

Little Rock, Arkansas, United States; Recruiting

Glendale, California, United States; Recruiting

San Diego, California, United States; Recruiting

Los Angeles, California, United States; Recruiting

Santa Monica, California, United States; Recruiting

Tustin, California, United States; Recruiting

Fountain Valley, California, United States; Recruiting

Colorado Springs, Colorado, United States; Recruiting

Naples, Florida, United States; Recruiting

Winter Park, Florida, United States; Recruiting

St. Petersburg, Florida, United States; Recruiting

South Miami, Florida, United States; Recruiting

Spring Hill, Florida, United States; Recruiting

Hallandale Bch, Florida, United States; Recruiting

Pembroke Pines, Florida, United States; Recruiting

Atlanta, Georgia, United States; Recruiting

Gainesville, Georgia, United States; Recruiting

Macon, Georgia, United States; Recruiting

Chicago, Illinois, United States; Recruiting

Danville, Indiana, United States; Recruiting

Overland Park, Kansas, United States; Recruiting

Topeka, Kansas, United States; Recruiting

Paducah, Kentucky, United States; Recruiting

Crestview Hills, Kentucky, United States; Recruiting

Chevy Chase, Maryland, United States; Recruiting

Newton, Massachusetts, United States; Recruiting

Hattiesburg, Mississippi, United States; Recruiting

Lincoln, Nebraska, United States; Recruiting

Las Vegas, Nevada, United States; Recruiting

New York, New York, United States; Recruiting

Raleigh, North Carolina, United States; Recruiting

Salisbury, North Carolina, United States; Recruiting

Toledo, Ohio, United States; Recruiting

Cincinnati, Ohio, United States; Recruiting

Dublin, Ohio, United States; Recruiting

Salem, Oregon, United States; Recruiting

Clarks Summit, Pennsylvania, United States; Recruiting

Columbia, South Carolina, United States; Recruiting

Austin, Texas, United States; Recruiting

Starting date: October 2007
Ending date: May 2008
Last updated: January 2, 2008