Clinical trial NCT00462254: Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease
Official title: Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Ramelteon
Parkinson's disease
Sleep disturbances
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 4
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with Parkinson's disease represent a significant proportion of VA elderly patients. Sleep disturbances and caregiver burnout association with this condition represent a significant problem. In this study, the investigators propose to perform an evaluation of a fixed doe of ramelteon on sleep in VA outpatients diagnosed with Parkinson's disease.

The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients with Parkinson's disease while indirectly improving the quality of life for the patients and caregivers. The investigators further hypothesize that these changes will occur through restructuring and normalization of the sleep architecture.

Detailed description: It is well established that sleep disturbances are common in patients with neurodegenerative disorders such as Parkinson's disease. Together with psychosis and other behavioral abnormalities they contribute to the stress, anxiety and cognitive decline of patients, caregiver burnout and depression, as well as health care provider frustration. The mechanisms of the sleep disturbances in these conditions are still poorly understood and no rational or effective treatments have been proposed. Recent data from a study of ramelteon in the elderly showed a striking ability of this compound to improve quality of sleep disturbances in Parkinson's disease.

Objectives of this study are:

* To examine the effects of ramelteon on the quality of sleep using sleep evaluation instruments (SDQ-Sleep Disorder Questionnaire and Neuropsychiatric Inventory with Caregiver Distress (NPI-D) Sleep Behavior Subscale administered to the patient and/or their bed partner.
* To examine the effects of ramelteon on daytime sleepiness and memory using Epworth Sleepiness Scale (ESS) and Hopkins Verbal Learning Test (HVLT).
* To examine the effects of ramelteon on the sleep/wake cycle and day/night activity patterns over a prolonged period of time (1 week) using a motion logger (continuous motor activity recording device) and computerized data analysis.
* To examine the effects of ramelteon on sleep architecture in a sample of patients with confirmed sleep disturbance, before and after ramelteon treatment by using polysomnography.

Eligibility criteria: Inclusion Criteria:

* 45-85 years of age and living in the community
* Male or female of non-child bearing potentials (non-child bearing is defined as at lease 6 months post-menopause or surgically sterile)
* Must have a diagnosis of Parkinson's disease
* Must have complaints of sleep disturbance

Exclusion Criteria:

* Patients with diagnosis of or those meeting DSM-IV criteria for major depression, schizophrenia or schizoaffective disorder, bipolar disorder, substance abuse disorder, other mental illness that is known to contribute to sleep disturbance, epilepsy, other medical conditions that are known to cause or contribute to sleep disturbances
* Patients currently using melatonin or ramelteon, hypnotics, benzodiazepines, antidepressants, blood-brain barrier permeable beta blockers, steroids, antipsychotics
* Patients with clinically significant blood or urine abnormalities
* Patients who have taken any investigational drug less than 1 month prior to the baseline visit
* Patients with multiple concomitant disorders with or without medications thought to produce sleep disturbances
* Patients with pre-existing sleep disturbances unrelated to Parkinson's disease
* Patients with severe hepatic impairment (Child-Pugh Class C)
* Patients with severe COPD (those with elevated pCO2 levels or those needing nocturnal oxygen therapy
* Patients with severe sleep apnea
* Patients who have sensitivity to ramelteon or any constituents of the Rozerem preparation
* Patients taking rifampin or potent inducers of CYP1A2, CYP3A4, CYP2C9 (ketoconazole, fluconazole)
* Patients living in a nursing home. Those living in assisted living facilities and board and care facilities may be included
* Patients unable to comply with the study protocol

Primary outcomes:
measure: Neuropsychiatric Inventory with Caregiver Distress (NPI-D) Sleep Behavior Subscale
timeFrame: One and one-half years
measure: The Epworth Sleepiness Scale
timeFrame: One and one-half years
measure: Sleep Disorders Questionnaire (short form)
timeFrame: One and one-half years
Secondary outcomes:
measure: Memory - Hopkins Verbal Learning Test (HVLT)
timeFrame: One and one-half years
measure: Movement - Abnormal Involuntary Movement Scale (AIMS)
timeFrame: One and one-half years
measure: Movement - Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: One and one-half years
measure: Movement - Continuous motor activity (actigraphy/motion logger)
timeFrame: One and one-half years
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
Study officials:
affiliation: VA Long Beach Healthcare System
name: Andrius Baskys, M.D.
role: PRINCIPAL_INVESTIGATOR
References: