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

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern California Institute for Research and Education

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