Safety of Ramelteon in Elderly Subjects

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Zolpidem

Criteria

Inclusion Criteria

• Self-reported sleep latency of 30 minutes or greater on at least 3 nights per week during the last 3 months.

• Body mass index between 18 and 34, inclusive

• Habitual bedtime between 9 pm and 1 am.

Exclusion Criteria

• Performance outside of normal limits on the EquiTest Motor Control Test at the Screening Visit.

• Average score on the EquiTest Sensory Organization Test #5 of less than 40 at the Screening Visit.

• Average score on the EquiTest Sensory Organization Test #6 of less than 40 at the Screening Visit.

• History of sleep apnea, restless leg syndrome, period limb movement syndrome, or other known disorders which affect sleep with the exception of insomnia.

• Current vestibular system disorder or inner ear disease.

• Recent history of clinically significant head injury.

• Significant visual acuity or field abnormalities that are not improved with the use of corrective lenses.

• History of balance disturbance or frequent falling.

• History of seizures, strokes, degenerative neurological disease, fibromyalgia, diabetic neuropathy, thyroid dysfunction, hypotension, clinically significant arthritis or musculoskeletal disorder.

• History of cancer, other than basal cell carcinoma, that has not been in remission for at least five years prior to the first dose of study drug.

• Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable.

• Acute clinically significant illness within two weeks or has been hospitalized within four weeks prior to the Screening Visit.

• History of treatment for a psychiatric disorder (including anxiety, depression, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past six months.

• History of drug addiction or drug abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised.

• History of alcohol abuse within the past 12 months.

• Any clinically important abnormal finding, as determined by medical history, physical examination, electrocardiogram or clinical laboratory tests, as determined by the investigator.

• Positive hepatitis panel.

• Positive urine drug screen for drugs known to alter sleep.

• Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first dose of single-blind study medication, whichever is longer.

• Any additional condition that in the Investigator's opinion would:

• affect sleep-wake function

• prohibit the subject from completing the study

• not be in the best interest of the subject.

• Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

• Melatonin and all other drugs or supplements known to affect sleep/wake function

• Anxiolytics

• Sedatives

• Hypnotics

• Central nervous system active drugs (including herbal)

• Antidepressants

• Narcotic analgesics

• Anticonvulsants

• Beta blockers

• Sedating H1 antihistamines

• St. John's Wort

• Systemic steroids

• Kava-kava

• Respiratory stimulants

• Ginkgo-biloba

• Decongestants

• Over-the-counter and prescription stimulants

• Antipsychotics

• Over-the-counter and prescription diet aids

• Muscle relaxants