Safety of Ramelteon in Elderly Subjects

NCT00568789 | Completed Phase 4

• 2 other identifiers: 01-05-TL-375-060U1111-1115-1906
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 6

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.

Conditions

Insomnia

Keywords

Insomnia; Aged; Postural Balance; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Sensory Organization Test Composite Score.

  Periods 1, 2, and 3 in the evening before sleep and during night when awakened from sleep.

Secondary Outcomes (5)

• 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.

Study Arms (1)

Ramelteon 8 mg, zolpidem 10 mg and placebo

EXPERIMENTAL

Drug: Ramelteon, zolpidem and placebo

Interventions

Ramelteon, zolpidem and placebo DRUG

Ramelteon 8 mg, tablets, orally, one night only during Period 1, 2 or 3 Zolpidem 10 mg, tablets, orally, one night only during Period 1, 2 or 3 Ramelteon/Zolpidem placebo-matching tablets, orally one night only during Period 1, 2 or 3

Also known as: Ambien, Rozerem™, TAK-375, ramelteon

Ramelteon 8 mg, zolpidem 10 mg and placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (6)

Unknown Facility

Costa Mesa, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Miramar, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

New York, New York, United States

Location

Related Publications (2)

• Zammit G, Wang-Weigand S, Peng X. Use of computerized dynamic posturography to assess balance in older adults after nighttime awakenings using zolpidem as a reference. BMC Geriatr. 2008 Jul 15;8:15. doi: 10.1186/1471-2318-8-15.

  PMID: 18627623 RESULT

• Zammit G, Wang-Weigand S, Rosenthal M, Peng X. Effect of ramelteon on middle-of-the-night balance in older adults with chronic insomnia. J Clin Sleep Med. 2009 Feb 15;5(1):34-40.

  PMID: 19317379 RESULT

Related Links

• Rozerem Package Insert

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon; Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 6, 2007
• Study Start: June 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (6)