Efficacy and Tolerability of Ramelteon in Patients With Rapid Eye Movement (REM) Behavior Disorder and Parkinsonism
Status:
Terminated
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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 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