Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324896
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2006-05-09
Brief Title:
Treatment of Insomnia in Patients With Parkinsons Disease A Multi-site Placebo-controlled Study of Eszopiclone
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Treatment of Insomnia in Patients With Parkinsons Disease A Multi-site Placebo-controlled Study of Eszopiclone
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parkinsons disease PD is the second most common neurodegenerative disease in the US affecting nearly 1 million Americans Up to 82 of community dwelling individuals with PD complain of sleep disturbances typically sleep fragmentation Despite the high prevalence of sleep problems and their impact on the life of these individuals there has been until recently little research focus on the problem This will be a multi-site double blind placebo-controlled two arm parallel group fixed-dose trial which will last 6 weeks Seventy patients at four sites 30 at the PIs site and a total of 40 patients at three external sites will be equally randomized to eszopiclone or placebo The primary hypothesis is that eszopiclone will be superior to placebo for the treatment of insomnia in patients with Parkinsons disease
Detailed Description:
Introduction and Rationale Parkinsons disease PD is the second most common neurodegenerative disease in the US affecting nearly 1 million Americans Up to 82 of community dwelling individuals with PD complain of sleep disturbances typically sleep fragmentation This difficulty with sleep maintenance is accompanied by a decrease in total sleep time and an increase in the number of awakenings and wakefulness after sleep The interactions between PD and sleep are complicated and many PD patients with insomnia have concomitant sleep disorders such as REM Sleep Behavior Disorder RBD Periodic Limb Movements of Sleep PLMS and Sleep Disordered Breathing SDB Nonetheless the majority of patients appear to have insomnia that is an integral symptom of PD rather than being related to specific sleep disorders Sleep difficulties in patients with PD are independent and important predictors of poor quality of life In addition sleep disturbances contribute to excessive daytime sleepiness EDS and poor daytime functioning as well as patients reduced enthusiasm for daily events and impairment in the quality of life of their spousal caregivers7 There are therefore a variety of reasons for us to address sleep problems in patients with PD
Despite the high prevalence of sleep problems and their impact on the life of these individuals there has been until recently little research focus on the problem While researchers have now begun to describe the phenomenology and epidemiology of sleep in PD there have few treatment studies from which the clinical community can derive guidance Despite this lack of evidenced-based clinical guidance community surveys indicate that up to 40 of patients with PD are taking sleeping pills3 Data published in 1999 indicate that the two most commonly used hypnotics in general practice were trazodone and zolpidem More recent data continue to show that trazodone is prescribed even more frequently than zolpidem We have recently completed a survey of 50 Parkinsons disease experts and found that the most commonly used hypnotics were zolpidem and trazodone Of note is also that these experts estimated that 40 of their patients with PD were using sleep medications
We have then the following clinical problem in the treatment of patients with PD Insomnia is very common and is strongly associated with a variety of adverse outcomes but there are no controlled data that can guide the approach to the treatment of these individuals Nevertheless clinicians appear to be using a number of hypnotics principally zolpidem and trazodone neither of which have been evaluated in PD or for long term use
Objectives
To test the safety and efficacy of eszopiclone for the treatment of insomnia in patients with Parkinsons disease
Hypothesis
Eszopiclone will result in significantly greater improvement than placebo in patient reported total sleep time diaries in patients with PD in an six week trial
Study Design and Duration
This will be a multi-site double blind placebo-controlled two arm parallel group fixed-dose trial which will last 6 weeks Seventy patients at four sites 30 at the PIs site and a total of 40 patients at three external sites will be equally randomized to eszopiclone or placebo
Preliminary screening will be conducted by telephone Inclusion and exclusion criteria are listed below Those individuals appearing appropriate will be scheduled for an in-person screening visit and will sign informed consent At the screening visit a detailed sleep medical and psychiatric history and a variety of background demographic forms See Schedule of Events - Appendix A will be completed
Subjects meeting all entrance criteria will be scheduled for a polysomnogram at the end of a two-week baseline period during which they will keep sleep-wake diaries Those who meet criteria for insomnia receive overnight polysomnographic evaluations to screen for primary sleep disorders of REM Sleep Behavior Disorder RBD Periodic Limb Movements of Sleep PLMS and Sleep Disordered Breathing SBD To minimize cost we plan to obtain one or two nights of baseline PSG evaluation depending on the amount of total sleep time observed on the first night of recording Patients who show 4 hours or more of total sleep including at least 30 min total of REM sleep will receive only one night of PSG evaluation These values were selected as the minimum necessary amount of sleep for evaluating concomitant sleep disorders Patients who do not meet these criteria on the first night or whose results are equivocal will receive a second night of baseline evaluation The exclusion criteria will apply to the either night If there is not sufficient sleep on either night the patient will be excluded
Polysomnographic evaluation will be conducted using standard nocturnal polysomnographic procedures This consists of 2 monopolar electroencephalographic EEG leads C3-A2 and O1-A2 2 monopolar electro-oculograms EOG bipolar submental chin and right and left tibialis leg electromyograms EMG and electrocardiogram ECG Respiratory airflow will be monitored through the use of a thermocouple Pro-Tech Services Inc placed at the nose and mouth Respiratory effort will be measured by plethysmography using piezoelectric sensors Pro-Tech Services Inc Snoring will be recorded through the use of a snoring sensor Pro-Tech Services Inc Arterial oxygen saturation will be measured with a finger probe and pulse oximeter Nonin All subjects will be videotaped during the PSG evaluation to provide positional and behavioral information regarding their sleep episode All sleep parameters will be collected simultaneously by a computerized acquisition system REMbrandt Medcare Diagnostics Sleep will be scored in 30-second epochs according to the standard criteria of Rechtschaffen and Kales
Those meeting entrance criteria will then be equally randomly assigned to receive eszopiclone or placebo treatment for 6 weeks Both groups will receive equal-appearing pills to be taken each night The dosing in the trial will be fixed and stratified by age those under 65 will receive 3 mg of eszopiclone or matching placebo at night those 65 or older will receive 2 mgs of eszopiclone or placebo at night
Patients will have visits at screen an interim phone contact to review the sleep diaries PSG baseline and weeks 2 4 and 6 at which medication will be monitored and pill intake therapeutic response and adverse events will be reviewed The procedures done at each visit are listed in Appendix A All groups will record sleep-wake diaries during the 2 week screening phase and for the first six weeks of the study
Patients will be asked but not be required to provide a care giver who will complete questionnaires at the screen visit and week 6 visit
Patients who terminate prematurely or who continue in the trial till the end will stop medication and continue to record diaries for one week at which time they will return for the final visit
Despite the high prevalence of sleep problems and their impact on the life of these individuals there has been until recently little research focus on the problem While researchers have now begun to describe the phenomenology and epidemiology of sleep in PD there have few treatment studies from which the clinical community can derive guidance Despite this lack of evidenced-based clinical guidance community surveys indicate that up to 40 of patients with PD are taking sleeping pills3 Data published in 1999 indicate that the two most commonly used hypnotics in general practice were trazodone and zolpidem More recent data continue to show that trazodone is prescribed even more frequently than zolpidem We have recently completed a survey of 50 Parkinsons disease experts and found that the most commonly used hypnotics were zolpidem and trazodone Of note is also that these experts estimated that 40 of their patients with PD were using sleep medications
We have then the following clinical problem in the treatment of patients with PD Insomnia is very common and is strongly associated with a variety of adverse outcomes but there are no controlled data that can guide the approach to the treatment of these individuals Nevertheless clinicians appear to be using a number of hypnotics principally zolpidem and trazodone neither of which have been evaluated in PD or for long term use
Objectives
To test the safety and efficacy of eszopiclone for the treatment of insomnia in patients with Parkinsons disease
Hypothesis
Eszopiclone will result in significantly greater improvement than placebo in patient reported total sleep time diaries in patients with PD in an six week trial
Study Design and Duration
This will be a multi-site double blind placebo-controlled two arm parallel group fixed-dose trial which will last 6 weeks Seventy patients at four sites 30 at the PIs site and a total of 40 patients at three external sites will be equally randomized to eszopiclone or placebo
Preliminary screening will be conducted by telephone Inclusion and exclusion criteria are listed below Those individuals appearing appropriate will be scheduled for an in-person screening visit and will sign informed consent At the screening visit a detailed sleep medical and psychiatric history and a variety of background demographic forms See Schedule of Events - Appendix A will be completed
Subjects meeting all entrance criteria will be scheduled for a polysomnogram at the end of a two-week baseline period during which they will keep sleep-wake diaries Those who meet criteria for insomnia receive overnight polysomnographic evaluations to screen for primary sleep disorders of REM Sleep Behavior Disorder RBD Periodic Limb Movements of Sleep PLMS and Sleep Disordered Breathing SBD To minimize cost we plan to obtain one or two nights of baseline PSG evaluation depending on the amount of total sleep time observed on the first night of recording Patients who show 4 hours or more of total sleep including at least 30 min total of REM sleep will receive only one night of PSG evaluation These values were selected as the minimum necessary amount of sleep for evaluating concomitant sleep disorders Patients who do not meet these criteria on the first night or whose results are equivocal will receive a second night of baseline evaluation The exclusion criteria will apply to the either night If there is not sufficient sleep on either night the patient will be excluded
Polysomnographic evaluation will be conducted using standard nocturnal polysomnographic procedures This consists of 2 monopolar electroencephalographic EEG leads C3-A2 and O1-A2 2 monopolar electro-oculograms EOG bipolar submental chin and right and left tibialis leg electromyograms EMG and electrocardiogram ECG Respiratory airflow will be monitored through the use of a thermocouple Pro-Tech Services Inc placed at the nose and mouth Respiratory effort will be measured by plethysmography using piezoelectric sensors Pro-Tech Services Inc Snoring will be recorded through the use of a snoring sensor Pro-Tech Services Inc Arterial oxygen saturation will be measured with a finger probe and pulse oximeter Nonin All subjects will be videotaped during the PSG evaluation to provide positional and behavioral information regarding their sleep episode All sleep parameters will be collected simultaneously by a computerized acquisition system REMbrandt Medcare Diagnostics Sleep will be scored in 30-second epochs according to the standard criteria of Rechtschaffen and Kales
Those meeting entrance criteria will then be equally randomly assigned to receive eszopiclone or placebo treatment for 6 weeks Both groups will receive equal-appearing pills to be taken each night The dosing in the trial will be fixed and stratified by age those under 65 will receive 3 mg of eszopiclone or matching placebo at night those 65 or older will receive 2 mgs of eszopiclone or placebo at night
Patients will have visits at screen an interim phone contact to review the sleep diaries PSG baseline and weeks 2 4 and 6 at which medication will be monitored and pill intake therapeutic response and adverse events will be reviewed The procedures done at each visit are listed in Appendix A All groups will record sleep-wake diaries during the 2 week screening phase and for the first six weeks of the study
Patients will be asked but not be required to provide a care giver who will complete questionnaires at the screen visit and week 6 visit
Patients who terminate prematurely or who continue in the trial till the end will stop medication and continue to record diaries for one week at which time they will return for the final visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None