A Safety Study of Ramelteon in Elderly People
Information source: Takeda Global Research & Development Center, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia
Intervention: ramelteon (Drug); zolpidem (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.
Summary
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.
Clinical Details
Official title: A Study of the Safety of Ramelteon in Elderly Subjects
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the effect of ramelteon on balance compared to placebo using zolpidem as a reference in healthy elderly subjects following a nighttime awakening.
Secondary outcome: To evaluate the effects of ramelteon on mobility.To evaluate the effects of ramelteon on memory functions. To evaluate the safety and tolerability of ramelteon.
Detailed description:
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.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Costa Mesa, California, United States
San Diego, California, United States
Miami, Florida, United States
Miramar, Florida, United States
Orlando, Florida, United States
New York, New York, United States
Additional Information
Starting date: June 2006
Ending date: September 2006
Last updated: June 10, 2008
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