InsomniaPhase 4NCT00568789
Safety of Ramelteon in Elderly Subjects
A Phase 4 study of Insomnia, run by Takeda at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2006to Sep 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 44Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Costa Mesa, California
Study site
Miami, Florida
Study site
Miramar, Florida
Study site
New York, New York
Study site
Orlando, Florida
Study site
San Diego, California
About this study
Official title: A Study of the Safety of Ramelteon in Elderly Subjects
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Ramelteon, zolpidem and placebo
- Keywords
- Insomnia, Aged, Postural Balance, Drug Therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramelteon, zolpidem and placeboDrug
Also called Ambien, Rozerem™, TAK-375, ramelteon
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
| Study group | Role | What they receive |
|---|---|---|
| Ramelteon 8 mg, zolpidem 10 mg and placebo | Experimental | Not described Receives: Drug: Ramelteon, zolpidem and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Organization Test Composite Score.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Periods 1, 2, and 3 during night when awakened from sleep and in the morning after self-awakening.
Immediate Memory Recall Test.
Measured: Periods 1, 2, and 3 during night when awakened from sleep.
Delayed Recall Test.
Measured: Periods 1, 2, and 3 during night when awakened from sleep.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startJun 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568789
- Sponsor's protocol ID
- 01-05-TL-375-060
- Other IDs
- U1111-1115-1906
- Status last verified
- Feb 2012
- First submitted
- 4 Dec 2007
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18627623Zammit 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.
PubMed 19317379
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety of Ramelteon in Elderly Subjects
- ClinicalTrials.gov ID
- NCT00568789
- Acronym / sponsor ID
- 01-05-TL-375-060
- Conditions
- Insomnia
- Keywords
- Insomnia, Aged, Postural Balance, Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramelteon 8 mg, zolpidem 10 mg and placebo | Experimental | Drug: Ramelteon, zolpidem and placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (44 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramelteon, zolpidem and placeboAlso: Ambien, Rozerem™, TAK-375, ramelteonRamelteon 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 | Drug | Ramelteon 8 mg, zolpidem 10 mg and placebo |
Primary outcome
Sensory Organization Test Composite Score.
Time frame: Periods 1, 2, and 3 in the evening before sleep and during night when awakened from sleep.
5 secondary outcomes
Equilibrium Score (ES) for SOT conditions 5 and 6 (evaluation of the effect of ramelteon on balance).
Time frame: 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).
Time frame: 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).
Time frame: Periods 1, 2, and 3 during night when awakened from sleep and in the morning after self-awakening.
Immediate Memory Recall Test.
Time frame: Periods 1, 2, and 3 during night when awakened from sleep.
Delayed Recall Test.
Time frame: Periods 1, 2, and 3 during night when awakened from sleep.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- Results publication: PubMed 18627623Zammit 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.
- Results publication: PubMed 19317379Zammit 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.
- Rozerem Package InsertLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Insomnia, run by Takeda at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Organization Test Composite Score. (time frame: Periods 1, 2, and 3 in the evening before sleep and during night when awakened from sleep.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00568789, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.