A Phase 4 interventional study of ROZEREM and Ramelteon in Parkinson's Disease, sponsored by Southern California Institute for Research and Education. Terminated at 1 site in United States. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-11-11.
Sponsored by Southern California Institute for Research and Education · Phase 4, Interventional, and Treatment
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.
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:
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 4 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Southern California Institute for Research and Education is the lead sponsor of 26 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Day 1-3: placebo run-in - 8 mg of placebo orally 30 minutes before bedtime. Days 4-11: true drug - 8 mg of Ramelteon orally 30 minutes before bedtime. Days 12-14: crossover - 8 mg of placebo orally 30 minutes before bedtime. Days 15-22: continue placebo.
Drug: ROZEREM
Day 1-3: Placebo run-in - 8 mg of placebo orally 30 minutes before bedtime. Days 4-11: continue placebo. Days 12-14: crossover - 8 mg of placebo orally 30 minutes before bedtime. Days 15-22: true drug - 8 mg of Ramelteon orally 30 minutes before bedtime.
Drug: Ramelteon
8 mg tablet orally 30 minutes before bedtime for 8 days (Days 4-11).
Also known as: Ramelteon
8 mg tablet orally 30 minutes before bedtime for 8 days (Days 15-22).
Also known as: Rozerem
Neuropsychiatric Inventory with Caregiver Distress (NPI-D) Sleep Behavior Subscale
Time frame: One and one-half years
The Epworth Sleepiness Scale
Time frame: One and one-half years
Sleep Disorders Questionnaire (short form)
Time frame: One and one-half years
Memory - Hopkins Verbal Learning Test (HVLT)
Time frame: One and one-half years
Movement - Abnormal Involuntary Movement Scale (AIMS)
Time frame: One and one-half years
Movement - Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: One and one-half years
Movement - Continuous motor activity (actigraphy/motion logger)
Time frame: One and one-half years
This study is terminated, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Southern California Institute for Research and Education