Parkinson Disease Clinical Trial
Official title:
A Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Disorder in Parkinson Disease
The purpose of this study is to determine whether melatonin prolonged-release (PR) and clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD).
RBD is one of the representative non-motor symptoms of PD. Patients with RBD show
dream-enacting behaviors such as punching, kicking, singing, screaming, or somnambulism.
These can interfere in sleep quality and increase the risk of falling down from the bed and
physical injuries of both the patient and sleep partner. Therefore, qualities of life of the
patient and sleep partner are negatively influenced by presence of RBD.
Clonazepam has been used for treatment of choice of RBD. However, the efficacy of clonazepam
is not proven in the clinical trial. Clonazepam has several side effects that could be
problematic in PD patients such as increasing fall-down risk, daytime somnolence, and
cognitive decline. Melatonin is a second-line treatment option for RBD, but there has been
only one randomized crossover trial that evaluated the efficacy of melatonin on RBD.
Finally, there has been no study that evaluate and compare the efficacy and safety of
melatonin and clonazepam for treatment of RBD.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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