REM Sleep Behavior Disorder
Conditions
Keywords
REM Sleep Behavior Disorder, Parkinson Disease, Placebos, Randomized Controlled Trial, Double-Blind Method, Clinical Trial
Brief summary
The purpose of this study is to determine whether clonazepam is 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 and other synucleinopathies. 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. It decreased RBD symptoms completely in 55-79% and partially in 11-32% of patients. However, these results are based on open-label or descriptive studies. There has been no randomized placebo controlled study that evaluated the efficacy and safety of clonazepam for treating RBD.
Interventions
DRUGClonazepam
For experimental treatment of RBD
DRUGPlacebo
Placebo pill manufactured to mask clonazepam 0.5mg tablet
Sponsors
Ministry of Food and Drug Safety, Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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) or Parkinson's syndrome * 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 * 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.)?
Exclusion criteria
* Existence of cognitive decline hard to participate in the clinical trial * Subject has confusion or visual hallucination in daytime * Diagnosed as obstructive sleep apnea or severe snoring * Previous clonazepam treatment within 4 weeks * Current treatment with benzodiazepines at bedtime * Alcoholics or drug abuser * Lactating, pregnant, or possible pregnant * Hypersensitivity to clonazepam or benzodiazepines * 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 |
|---|---|
| Clinical Global Impression-Severity scale (CGI-S) | Four weeks (plus or minus 3 days) |
| Epworth Sleepiness Scale (ESS) | Four weeks (plus or minus 3 days) |
| Parkinson Disease Sleep Scale (PDSS) | Four weeks (plus or minus 3 days) |
| Montreal Cognitive Assessment (MoCA) | Four weeks (plus or minus 3 days) |
| Unified Parkinson's Disease Rating Scale (UPDRS) | Four weeks (plus or minus 3 days) |
Countries
South Korea
Outcome results
None listed