Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Northwestern University
With
Takeda
See above.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism
