Treating Sleep/Wake Cycle Disturbances in Basal Ganglia Disorders With Ramelteon
NCT00907595 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2012-11-06
Summary
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.
Conditions
- Huntington's Disease
- Parkinson's Disease
- Dementia With Lewy Bodies
- Sleep Disorders
- Circadian Dysregulation
Interventions
- DRUG
-
Ramelteon
After 2 weeks of baseline sleep study, subjects will be randomized to take either Ramelteon or Placebo for 4 weeks.
- DRUG
-
After 2 weeks of baseline sleep study, subjects will be randomized to take either Ramelteon or Placebo for 4 weeks.
Sponsors & Collaborators
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Kaloyan S Tanev, MD · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2010-03-31
- Completion
- 2010-07-31
Countries
- United States
Study Locations
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