Parkinson Disease, REM Sleep Behavior Disorder
Conditions
Keywords
REM Sleep Behavior Disorder, Parkinson Disease, Randomized Controlled Trial, Clinical Trial, Melatonin, Clonazepam
Brief summary
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).
Detailed description
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.
Interventions
DRUGMelatonin PR
For experimental treatment of RBD
DRUGClonazepam
For experimental treatment of RBD
DRUGMelatonin PR placebo
Placebo pill manufactured to mask melatonin PR 2mg tablet
DRUGClonazepam placebo
Placebo pill manufactured to mask clonazepam 0.5mg tablet
Sponsors
Kuhnil Pharmaceutical Co., Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject was enrolled voluntarily and understood the contents of this clinical trial * Subject was diagnosed as Parkinson disease (PD) * Hoehn and Yahr (H&Y) stage 1, 2, or 3 * Existence of caregivers who can provide a information about symptoms of rapid eye movement sleep disorder (RBD) of the participant * RBD frequency is one or more per week * Existence of RBD by answering yes to the question (RBD-1Q): Have you ever been told, or suspected yourself, that you seem to 'act out your dreams' while asleep (for example, punching, flailing your arms in the air, making running movements, etc.)? * Good compliance for reporting PGI scores and sleep diary
Exclusion criteria
* Existence of cognitive decline hard to participate in the clinical trial * Hypersensitivity to melatonin or clonazepam * Previous melatonin or clonazepam treatment within 1 month * Changing anti-parkinsonian medications within 1 month * Current treatment with sedatives or hypnotics at bedtime * Diagnosed as epilepsy or current treatment with anti-epileptic drugs * Severe trauma history due to RBD * Lactating, pregnant, or possible pregnant * Subject has confusion or visual hallucination in daytime * Diagnosed as obstructive sleep apnea or severe snoring * Diagnosed as other parasomnia * Presence of severe psychiatric illness * Alcoholics or drug abuser * Myasthenia gravis * Acute narrow-angle glaucoma * Prior participation to other clinical trials within 3 months * Presence of severe comorbidities or a cancer * Existence of illness or problems which makes difficult to be enrolled to this trial judged by clinicians
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression-Improvement scale (CGI-I) | Four weeks (plus or minus 3 days) | Clinician assessed rating scale of clinical improvement or worsening relative to a baseline state, scored as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. |
Secondary
| Measure | Time frame |
|---|---|
| Mean change of the Montreal Cognitive Assessment (MoCA) | Four weeks (plus or minus 3 days) |
| Mean change of the Unified Parkinson's Disease Rating Scale (UPDRS) | Four weeks (plus or minus 3 days) |
| Sleep diary | Four weeks (plus or minus 3 days) |
| Mean change of the Epworth Sleepiness Scale (ESS) | Four weeks (plus or minus 3 days) |
| Mean change of the Parkinson Disease Sleep Scale (PDSS) | Four weeks (plus or minus 3 days) |
| Patient Global Impression-Improvement scale (PGI-I) | Four weeks (plus or minus 3 days) |
| Mean change of the Patient Global Impression-Severity scale (PGI-S) | Four weeks (plus or minus 3 days) |
| modified RBD Questionnaire-HongKong (mRBDQ-HK) | Four weeks (plus or minus 3 days) |
| Mean change of the Clinical Global Impression-Severity scale (CGI-S) | Four weeks (plus or minus 3 days) |
Countries
South Korea
Contacts
Primary ContactBeomseok Jeon, MD, PhD
Backup ContactChae Won Shin, MD, MSc
Outcome results
None listed