Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease
Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease
Sponsors
Source
Southern California Institute for Research and Education
Oversight Info
Has Dmc
No
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.
Overall Status
Terminated
Start Date
2007-06-01
Completion Date
2008-06-01
Primary Completion Date
2008-06-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Neuropsychiatric Inventory with Caregiver Distress (NPI-D) Sleep Behavior Subscale |
One and one-half years |
|
The Epworth Sleepiness Scale |
One and one-half years |
|
Sleep Disorders Questionnaire (short form) |
One and one-half years |
Secondary Outcome
Measure |
Time Frame |
|
Memory - Hopkins Verbal Learning Test (HVLT) |
One and one-half years |
|
Movement - Abnormal Involuntary Movement Scale (AIMS) |
One and one-half years |
|
Movement - Unified Parkinson's Disease Rating Scale (UPDRS) |
One and one-half years |
|
Movement - Continuous motor activity (actigraphy/motion logger) |
One and one-half years |
Enrollment
4
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
8 mg tablet orally 30 minutes before bedtime for 8 days (Days 4-11).
Arm Group Label
A
Other Name
Ramelteon
Intervention Type
Drug
Intervention Name
Description
8 mg tablet orally 30 minutes before bedtime for 8 days (Days 15-22).
Arm Group Label
B
Other Name
Rozerem
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
Gender
All
Minimum Age
45 Years
Maximum Age
85 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Andrius Baskys, M.D. |
Principal Investigator |
VA Long Beach Healthcare System |
Location
Facility |
|
VA Long Beach Healthcare System Long Beach California 90822 United States |
Location Countries
Country
United States
Verification Date
2010-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Name Title
Andrius Baskys, M.D.
Organization
VA Long Beach Healthcare System
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
A
Arm Group Type
Other
Description
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.
Arm Group Label
B
Arm Group Type
Other
Description
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.
Firstreceived Results Date
N/A
Why Stopped
Study discontinued.
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)
Study First Submitted
April 16, 2007
Study First Submitted Qc
April 17, 2007
Study First Posted
April 18, 2007
Last Update Submitted
November 10, 2010
Last Update Submitted Qc
November 10, 2010
Last Update Posted
November 11, 2010
Pending Results
Submitted
December 26, 2012
May 30, 2013
Returned
February 5, 2013
July 3, 2013
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.