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

Sponsored by:	Southern California Institute for Research and Education
Information provided by:	Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:	NCT00462254

Purpose

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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Caregivers Parkinson's Disease Sleep Disorders

Drug Information available for: Ramelteon

U.S. FDA Resources

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

Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:

Neuropsychiatric Inventory with Caregiver Distress (NPI-D) Sleep Behavior Subscale [ Time Frame: One and one-half years ] [ Designated as safety issue: No ]
The Epworth Sleepiness Scale [ Time Frame: One and one-half years ] [ Designated as safety issue: No ]
Sleep Disorders Questionnaire (short form) [ Time Frame: One and one-half years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Memory - Hopkins Verbal Learning Test (HVLT) [ Time Frame: One and one-half years ] [ Designated as safety issue: No ]
Movement - Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: One and one-half years ] [ Designated as safety issue: No ]
Movement - Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: One and one-half years ] [ Designated as safety issue: No ]
Movement - Continuous motor activity (actigraphy/motion logger) [ Time Frame: One and one-half years ] [ Designated as safety issue: No ]

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).

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

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462254

Locations

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.

Sponsors and Collaborators

Southern California Institute for Research and Education

Investigators

Principal Investigator:

Clifford Widmark, M.D.

VA Long Beach Healthcare System

More Information

Southern California Institute for Research and Education website This link exits the ClinicalTrials.gov site

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

Keywords provided by Southern California Institute for Research and Education:

Ramelteon
Parkinson's disease
Sleep disturbances

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009