Safety of Ramelteon in Elderly Subjects

Phase 4

Completed

• Conditions: Insomnia
• Interventions: Drug: Ramelteon, zolpidem and placebo

• Registration Number: NCT00568789
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to investigate the effects of ramelteon in elderly subjects on balance, mobility and memory impairment after awakening in the middle of the night following bedtime dosing.

Detailed Description

Insomnia affects more than half of the US population. Epidemiological data indicate that between 36% and 56% of American adults report occasional insomnia, while 9% to 17% report chronic or severe problems with insomnia. This condition is most prevalent in the elderly. Elderly insomnia sufferers may experience more difficulty staying asleep than younger adults; increasing wakefulness during the sleep period and resulting in the opportunity to get out of bed.

Elderly individuals with insomnia are at risk of falling when they get out of bed during the sleep period. It is not known if this risk merely is the result of being out of bed, or if insomnia or some other physiological processes (eg, postural hypotension) contribute. This risk is significant because falling may result in severe injuries, including hip fractures, for which morbidity and mortality statistics are remarkable. Approximately one-third of those who sustain a hip fracture are placed in long-term care facilities. Of those patients hospitalized due to a hip fracture, 15% die while in the hospital and 33% die within one year of sustaining the fracture.

One important concern regarding the risk of falling in elderly patients with insomnia relates to the commonly accepted pharmacological treatments of insomnia. Although normal control of the sleep-wake cycle is exerted by the suprachiasmatic nucleus via melatonin receptor subtypes 1 and 2 receptors, current pharmacologic treatments for insomnia mainly involve GABAergic (gamma aminobutyric acid) mechanisms: most currently prescribed sleep agents are benzodiazepine receptor agonists, which bind to the benzodiazepine receptor site of the gamma aminobutyric acid receptor complex. Gamma aminobutyric acid is the major inhibitory transmitter in the central nervous system and its receptors are distributed widely throughout the brain. In addition to sleep, benzodiazepine receptor agonists can cause a wide range of ancillary effects not directly related to sleep, depending on the precise subset of gamma aminobutyric acid receptors activated. These include sedative, anxiolytic, muscle-relaxant, and amnesic effects. Drugs that act at this receptor complex, specifically the benzodiazepines, have deleterious effects on body sway.

Ramelteon is marketed in the United States as Rozerem for the treatment of insomnia characterized by difficulty with sleep initiation. It's mechanism of action is based on the agonism of melatonin receptor subtype 1 and 2.

This study will investigate the effects of ramelteon on balance, mobility and memory impairment awakening in the middle of the night following bedtime dosing. Participation in this study is anticipated to be about 1 to 1.5 months.

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ramelteon 8 mg, zolpidem 10 mg and placebo	Ramelteon, zolpidem and placebo	-

Primary Outcome Measures

Name	Time	Method
Sensory Organization Test Composite Score.	Periods 1, 2, and 3 in the evening before sleep and during night when awakened from sleep.

Secondary Outcome Measures

Name	Time	Method
Equilibrium Score (ES) for SOT conditions 5 and 6 (evaluation of the effect of ramelteon on balance).	Periods 1, 2, and 3 during night when awakened from sleep and in the morning after self-awakening.
Sensory Organization Test derived ratios: Somatosensory, Visual, Vestibular, and Preference (effect on balance).	Periods 1, 2, and 3 in the evening before sleep and during night when awakened from sleep.
Results of the Step/Quick Turn Test (SQTT), which quantifies turn performance characteristics, were obtained with NeuroCom EquiTest computerized dynamic posturography equipment (effect on mobility and balance).	Periods 1, 2, and 3 during night when awakened from sleep and in the morning after self-awakening.
Immediate Memory Recall Test.	Periods 1, 2, and 3 during night when awakened from sleep.
Delayed Recall Test.	Periods 1, 2, and 3 during night when awakened from sleep.