Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism

Seoul National University Hospital40 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

REM Sleep Behavior Disorder

Interventions

ClonazepamDRUG

For experimental treatment of RBD

PlaceboDRUG

Placebo pill manufactured to mask clonazepam 0.5mg tablet

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Clinical Global Impression-Improvement scale (CGI-I)

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.