A Safety Study of Ramelteon in Elderly People - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00568789

Purpose

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.

Condition	Intervention	Phase
Insomnia	Drug: ramelteon Drug: zolpidem Drug: placebo	Phase IV

MedlinePlus related topics: Memory

Drug Information available for: Ramelteon Zolpidem

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Study of the Safety of Ramelteon in Elderly Subjects

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the effects of ramelteon on mobility. [ Time Frame: 5 Weeks Total ] [ Designated as safety issue: No ]
To evaluate the effects of ramelteon on memory functions. [ Time Frame: 5 Weeks Total ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of ramelteon. [ Time Frame: 5 Weeks Total ] [ Designated as safety issue: Yes ]

Enrollment:	33
Study Start Date:	June 2006
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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

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

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568789

Locations

United States, California

Costa Mesa, California, United States

San Diego, California, United States
United States, Florida

Miami, Florida, United States

Miramar, Florida, United States

Orlando, Florida, United States
United States, New York

New York, New York, United States

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Sherry Weigand, MD, PhD

Takeda Global Research & Development Center, Inc.

More Information

Responsible Party:	Takeda Global Research & Development Center, Inc. ( VP, Clinical Science )
Study ID Numbers:	01-05-TL-375-060
Study First Received:	December 4, 2007
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00568789
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Insomnia
Aged
Postural Balance
Drug Therapy

Study placed in the following topic categories:

Zolpidem

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
GABA Agonists
Hypnotics and Sedatives

Physiological Effects of Drugs
Central Nervous System Depressants
GABA Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009