Parkinson's Disease Clinical Trial
Official title:
Treating Sleep Wake Cycle Disturbances in Basal Ganglia Neurodegenerative Disorder Subjects With Ramelteon- A Double Blind, Placebo Controlled Trial
The proposed study is a double-blind, placebo controlled pilot study of HD, PD, and DLB subjects with sleep disturbances. This study is designed to determine the effects of 4 weeks Ramelteon treatment on the sleep patterns of people with basal ganglia disorders such as HD, PD and DLB. The study also aims to look at the sleep patterns of caregivers of people with HD, PD and DLB.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 90 Years |
Eligibility |
We will recruit 24 Huntington's disease, Parkinson's Disease, or Dementia with Lewy Bodies
subjects. Assuming a dropout rate of 20%, we expect that 20 of the 24 subjects who
initially enroll will complete the study. Inclusion criteria will be the following: - Subjects with HD will be between the ages of 20 and 65 years old; - Subjects with PD or DLB will be between the ages of 40 and 90; - Subjects will have subjective complaints of sleeping problems or their caregivers will complain of the subjects not sleeping well - Subjects with all severity of HD, PD, and DLB symptoms will be accepted as long as they complain of sleep problems - A diagnosis of HD, PD, or DLB. For HD patients, a positive HD gene status for everyone except the caregivers will have been obtained for clinical reasons and will be known at the time of enrollment into the study. PD patients will have a clinical diagnosis of PD. DLB patients will have a diagnosis of possible or probably DLB based on consensus criteria (outlined in McKeith et al., 2005). - Subjects will be willing and able to participate in the informed consent process. Exclusion criteria will be the following: - Subjects who are unable to participate in the informed consent process - Subjects with previously documented primary sleep disorders (unrelated to HD, PD, or DLB), including Obstructive Sleep Apnea Syndrome, Periodic Limb Movement Disorder of Sleep, or Narcolepsy. - Subjects taking fluvoxamine, rifampin, ketoconazole , and fluconazole within 30 days of baseline - Subjects with hepatic impairment - Subjects who perform shift work or have any other circadian rhythm abnormality or disruption - Subjects who are diagnosed with a Major Depressive Episode, current at the time of enrollment (subject may have a history of a Major Depressive Episode as long as it is in partial or full remission at the time of enrollment) - Subjects who are diagnosed with a manic or hypomanic episode, current at the time of enrollment (subject may have a history of a manic or hypomanic episode as long as it is in full remission at the time of enrollment) - Subjects who at the time of enrollment receive hypnotic agents or have been on hypnotic agents during the two weeks prior to enrollment - Subjects who are pregnant at the time of enrollment or intend to become pregnant during the period of study participation - Subjects who in the opinion of the research personnel would not be able to participate in the research protocol because of agitation, lack of transportation, or other reasons. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Ancoli-Israel S, Clopton P, Klauber MR, Fell R, Mason W. Use of wrist activity for monitoring sleep/wake in demented nursing-home patients. Sleep. 1997 Jan;20(1):24-7. — View Citation
Hurelbrink CB, Lewis SJ, Barker RA. The use of the Actiwatch-Neurologica system to objectively assess the involuntary movements and sleep-wake activity in patients with mild-moderate Huntington's disease. J Neurol. 2005 Jun;252(6):642-7. Epub 2005 Mar 7. — View Citation
Morton AJ, Wood NI, Hastings MH, Hurelbrink C, Barker RA, Maywood ES. Disintegration of the sleep-wake cycle and circadian timing in Huntington's disease. J Neurosci. 2005 Jan 5;25(1):157-63. Erratum in: J Neurosci. 2005 Apr 13;25(15):3994. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep efficiency and other actigraphy derived sleep parameters | 2 weeks pre intervention; 4 weeks of the intervention; 2 weeks after intervention | Yes | |
Secondary | UHDRS, UPDRS, cognitive measures, mood symptoms, aggression measures, functional ability. | 2 weeks pre intervention; 4 weeks of the intervention; 2 weeks after intervention | Yes |
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