Status:
TERMINATED
Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Takeda
Conditions:
REM Behavior Disorder
Parkinsonism
Eligibility:
All Genders
Phase:
NA
Brief Summary
Parkinson's disease (PD) is the second most common neurodegenerative disorder of the elderly that affects a million patients in US. Sleep dysfunction impacts up to 90% of PD patients. PD patients expe...
Detailed Description
See above.
Eligibility Criteria
Inclusion
- Diagnosis of parkinsonism (idiopathic PD, multiple systems atrophy, Lewy body dementia)
- RBD frequency of at least once per week based on the RBD screening clinical questionnaire
- PSG evidence of RBD
- Presence of bed partner/caregiver who sleeps in the same room as PD patient
Exclusion
- Known hypersensitivity to ramelteon or related compounds, including melatonin and melatonin-related compounds.
- Use of hypnotics or other sedatives within a month prior to the study initiation
- Presence of active psychosis
- Use of neuroleptics, except for the atypical neuroleptics - specifically quetiapine (the dose should not exceed 50mg/day)
- Use of antidepressants unless the patient has been on a stable dose for at least three months
- Use of Venlafaxine (Effexor®)
- Presence of cognitive impairment, defined as the Mini Mental Status Examination (MMSE) score \<24
- Presence of depression defined as the Beck Depression Inventory (BDI) score \>14
- Significant sleep disordered breathing (defined as an apnea-hypopnea index\>15 events/hr of sleep on screening PSG), significant periodic limb movement disorder (defined as a PLM index\>10 events/hr of sleep with awakening on screening PSG)
- Travel through two time zones within a month prior to the study initiation
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00745030
Start Date
June 1 2008
End Date
December 1 2009
Last Update
January 9 2024
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611