Official Title: “A Study of the Safety of Ramelteon in Elderly Subjects”

This is a crossover study of ramelteon 8 mg and zolpidem 10 mg compared with placebo in elderly patients with primary insomnia. Each subject is to receive a treatment sequence of all three treatments, randomized to different order; each treatment is for 1 day, with a washout period between each treatment. This study is designed to investigate the effects of ramelteon on balance, mobility, and memory impairment after middle-of-the-night awakening following bedtime dosing.

Study Type: Interventional

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

Study Primary Completion Date: September 2006

Subjects participating in this study will be randomized to receive in different order a single dose of 8 mg of ramelteon, 10 mg of zolpidem and a placebo over three overnight stays at a research facility. The 3 treatment days are each separated by a 5 to 10 days.

Subjects will be given their assigned treatment as a single dose on the night of treatment, awakened 2 hours after dosing, and tested for mobility, balance, immediate memory recall, and delayed memory recall. Safety is to be measured through the record of adverse events, vital sign measurements, clinical laboratory tests, and electrocardiogram tracing.

Intervention(s) in this Clinical Trial

• Drug: ramelteon
  • 8 mg ramelteon tablet, orally, one night only
• Drug: zolpidem
  • 10 mg zolpidem tablet, orally, one night only
• Drug: placebo
  • Placebo tablet, orally, one night only

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• To evaluate the effect of ramelteon on balance compared to placebo using zolpidem as a reference in healthy elderly subjects following a nighttime awakening.
  • Time Frame: 5 Weeks Total
    Safety Issue?: No

Secondary Measures

• To evaluate the effects of ramelteon on mobility.
  • Time Frame: 5 Weeks Total
    Safety Issue?: No
• To evaluate the effects of ramelteon on memory functions.
  • Time Frame: 5 Weeks Total
    Safety Issue?: No
• To evaluate the safety and tolerability of ramelteon.
  • Time Frame: 5 Weeks Total
    Safety Issue?: Yes

Inclusion Criteria:

• Subject is at least 65 years of age.
• Subject has a self-reported sleep latency of at least 30 minutes on at least 3 nights per week during the 3 months prior to enrollment.
• Subject has a habitual bedtime between 9:00 PM and 1:00 AM.

Exclusion Criteria:

• Subject has a history of sleep apnea, restless leg syndrome, periodic limb movement syndrome, or other known disorders that affect sleep (except insomnia).
• Subject has a current vestibular system disorder or inner ear disease.
• Subject has a recent history of clinically significant head injury.
• Subject has a history of seizures, strokes, degenerative neurological disease, fibromyalgia, diabetic neuropathy, thyroid dysfunction, hypotension, clinically significant arthritis or musculoskeletal disorder, balance disturbance, frequent falling, or significant visual acuity of field abnormalities that were not improved with corrective lenses.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Takeda Global Research & Development Center, Inc.

Overall Clinical Trial Officials and Contacts

Sherry Weigand, MD, PhD Study Director Takeda Global Research & Development Center, Inc.  

Information obtained from ClinicalTrials.gov on January 08, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00568789

Study ID Number: 01-05-TL-375-060

ClinicalTrials.gov Identifier: NCT00568789

Health Authority: United States: Food and Drug Administration