Status:
TERMINATED
Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease
Lead Sponsor:
Southern California Institute for Research and Education
Conditions:
Parkinson's Disease
Eligibility:
All Genders
45-85 years
Phase:
PHASE4
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. I...
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 cont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00462254
Start Date
June 1 2007
End Date
June 1 2008
Last Update
November 11 2010
Active Locations (1)
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1
VA Long Beach Healthcare System
Long Beach, California, United States, 90822