NCT00462254

Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Southern California Institute for Research and Education · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	ROZEREM	8 mg tablet orally 30 minutes before bedtime for 8 days (Days 4-11).
DRUG	Ramelteon	8 mg tablet orally 30 minutes before bedtime for 8 days (Days 15-22).

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-04-18
• Last updated: 2010-11-11

Locations

1 site across 1 country: United States