Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism
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 experience a variety of sleep disorders including parasomnias, specifically REM behavior disorder (RBD) that can precede the onset of motor manifestations of PD. RBD has negative consequences on patients' and their bed partners' quality of life mainly due to its impact on the sleep quality and day time alertness. RBD also predisposes affected individuals and their bed partners to physical injuries.
There are no FDA approved treatments for RBD. Clonazepam is the most commonly used treatment but carries risks of daytime sedation, tolerance, and withdrawal symptoms. More recently, melatonin has been demonstrated to be effective in several small studies. Ramelteon, a selective melatonin receptor agonist with favorable safety profile, could potentially be effective for the treatment of RBD.
This pilot protocol will investigate safety and efficacy of ramelteon for the treatment of RBD in subjects with parkinsonism. We plan to recruit 20 subjects with RBD diagnosed based on the clinical interview and confirmed by the polysomnographic (PSG) data. The study is designed as a prospective randomized placebo controlled 12-week study. Primary outcome measure will be change in frequency of RBD events based on the daily sleep diaries. Secondary outcome measure will be change in the amount of tonic muscle activity based on the results of the baseline and final PSG. A number of other secondary and exploratory outcome measures will be collected
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Tolerability of Ramelteon in Patients With REM Behavior Disorder and Parkinsonism: A Placebo Controlled, Double Blind, Randomized, Prospective Pilot Study|
- Change in the Frequency of RBD Based on the Daily Sleep Diaries, Completed Daily for the Duration of the Study by the Study Subjects' Bed Partners/Caregivers [ Time Frame: 12 weeks ]
Change in the frequency of RBD based on the daily sleep diaries, completed daily for the duration of the study by the study subjects' bed partners/caregivers.
Data will not be analyzed. The protocol is being terminated due to low subject enrollment and recruitment.
- Change in the Amount of Tonic Muscle Activity Based on the Results of the Baseline and Final Polysomnographic (PSG) Study [ Time Frame: 8 weeks ]
- Changes in Mean TST, LPS, WASO (Based on PSG) [ Time Frame: 8 weeks ]
- Changes in Clinician Global Impression Scale of Improvement (CGI-I) [ Time Frame: 10 weeks ]
- Changes in RBD Structured Questionnaire (Completed by Patient and Bed Partner) [ Time Frame: 12 weeks ]
- Changes in Patient Completed Parkinson's Disease Sleep Scale (PDSS)- the Only Validated PD Specific, Questionnaire-based, Sleep Evaluation Scale [ Time Frame: 12 weeks ]
- Changes in Patient Completed Epworth Sleepiness Scale (ESS) [ Time Frame: 12 weeks ]
- Changes in Beck Depression Inventory (BDI) [ Time Frame: 12 weeks ]
- Changes in Pittsburgh Sleep Quality Index (PSQI) (Patient Completed) [ Time Frame: 12 weeks ]
- Changes in Patient Completed The Fatigue Severity Scale (FSS) [ Time Frame: 12 weeks ]
- Changes in Patient Completed PDQ-39 Scale(PD-specific Quality of Life Scale) [ Time Frame: 12 weeks ]
- Changes in Physician Completed United Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 12 weeks ]
- Changes in Mini-Mental State Exam (MMSE) [ Time Frame: 12 weeks ]
- Changes in The Montreal Cognitive Assessment Scale (MoCA) [ Time Frame: 12 weeks ]
- Study Terminated Due to Low Subject Recruitment and Enrollment.Low subject recruitment and enrollment
|Study Start Date:||June 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Ramelteon (TAK-375) 8mg tablets
Subjects take 1 8mg tablet 30 minutes before bedtime everyday for 8 weeks.
Placebo Comparator: 2
Placebo 8 mg tablets
Placebo 8 mg tablets
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745030
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Tanya Simuni, M.D.||Northwestern University, Department of Neurology|
|Study Director:||Aleksandar Videnovic, M.D.||Northwestern University, Department of Neurology|