Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Southern California Institute for Research and Education |
---|---|
Information provided by: | Southern California Institute for Research and Education |
ClinicalTrials.gov Identifier: | NCT00462254 |
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.
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: ROZEREM Drug: Ramelteon |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease |
Estimated Enrollment: | 15 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A
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
8 mg tablet orally 30 minutes before bedtime for 8 days (Days 4-11).
|
B
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 15-22).
|
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:
Ages Eligible for Study: | 45 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
VA Long Beach Healthcare System | Recruiting |
Long Beach, California, United States, 90822 | |
Contact: Jennifer Koontz, M.A 562-826-8000 ext 4313 Jennifer.Koontz@va.gov | |
Contact: Gardner Ricca 562-826-8000 ext 4313 Ricca.Gardner@va.gov | |
Principal Investigator: Clifford Widmark, M.D. |
Principal Investigator: | Clifford Widmark, M.D. | VA Long Beach Healthcare System |
Responsible Party: | VA Long Beach Healthcare System ( Clifford Widmark, M.D. ) |
Study ID Numbers: | #789 |
Study First Received: | April 16, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00462254 |
Health Authority: | United States: Institutional Review Board |
Ramelteon Parkinson's disease Sleep disturbances |
Ganglion Cysts Basal Ganglia Diseases Sleep Disorders Dyssomnias Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Signs and Symptoms Parkinson Disease Movement Disorders Mental Disorders Neurologic Manifestations Parkinsonian Disorders |
Nervous System Diseases |