A Study to Evaluate the Ability of Ramelteon to Alleviate the Insomnia Symptoms Associated With Eastward Bound Jet Lag in Healthy Adult Volunteers

Condition(s) targeted: Jet Lag Syndrome; Sleep Disorder; Circadian Rhythm; Insomnia

Intervention: 1 mg Ramelteon (Drug); 4 mg Ramelteon (Drug); 8 mg Ramelteon (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

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.

This is a study to evaluate the ability of ramelteon to alleviate the insomnia symptoms of eastbound jet lag in healthy adult volunteers. Subjects are screened in Hawaii, and then travel to the Eastern Time Zone for randomization to receive either ramelteon or a placebo during evaluation in a sleep laboratory.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Ability of Ramelteon 1 mg, 4 mg, and 8 mg to Alleviate the Insomnia Symptoms Associated With Eastward Bound Jet Lag Across 5 Time Zones in Healthy Adult Volunteers

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To evaluate the ability of 1 mg, 4 mg and 8 mg of ramelteon to alleviate the insomnia symptoms associated with rapid, eastward travel across 5 time zones.

Secondary outcome:

To evaluate the safety of 1 mg, 4 mg and 8 mg of ramelteon.

To evaluate the ability of 1 mg, 4 mg and 8 mg of ramelteon to alleviate other symptoms associated with rapid, eastward travel across 5 time zones.

To determine whether 1 mg, 4 mg and 8 mg of ramelteon, compared with placebo, could facilitate restoration of normal circadian phase relationships as measured by salivary melatonin secretion offset time after imposition of a 5-hour phase advance.

Detailed description: Subjects participating in this study will undergo screening in Hawaii and travel to the East Coast of the United States for evaluation in a sleep laboratory. Once on the East Coast, subjects will be confined to a sleep laboratory for 6 days and 5 nights, where they will receive either 1 mg, 4 mg or 8 mg of ramelteon, or a placebo for 4 nights. After Day 6, subjects return to Hawaii. Two days later, subjects will receive a telephone follow-up call to assess the status of their jet lag insomnia and other symptoms.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The subject is a healthy male or female adult volunteer aged 18 to 50 who must have

lived in Hawaii for at least 12 months and has not been traveling outside of Hawaii for 4 consecutive days within 30 days prior to the Outpatient Screening Visit.

- The subject has sleep disturbance associated with jet lag symptoms, with at least two

occurrences in the last three years.

- The subject has had within the past 3 months, bedtime hours between 9: 00 pm and 12: 00

am and between 6. 5 hours and 9 hours of total sleep time.

Exclusion Criteria:

- Subjects with a history of primary sleep disorders diagnosed within the past 6

months.

- Subjects treated for a psychiatric disorder (including anxiety or depression) within

the past 12 months.

- Subjects with a history of seizures, sleep apnea, restless leg syndrome (RLS),

periodic limb movement syndrome (PLMS), chronic obstructive pulmonary disease (COPD), schizophrenia, bipolar disorder, mental retardation, or cognitive disorder.

- Subjects with sleep schedule changes required by employment (eg, shift worker) within

3 months prior to the administration of study medication.

- Subjects who smoke more than 3 cigarettes per day or use tobacco products during

nightly awakenings, or who report high caffeine consumption (greater than 600 mg daily).

- Subjects with a known allergic reaction to the study drug (ie, ramelteon or related

compounds, including melatonin, and melatonin-related compounds) or who have used prescription or over-the-counter (OTC) hypnotic medication (including melatonin) within 3 months of the screening visits.

Miami, Florida, United States

Pembroke Pines, Florida, United States

Honolulu, Hawaii, United States

New York, New York, United States

Starting date: February 2007
Ending date: September 2007
Last updated: June 10, 2008