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

Seoul National University

Status and phase

Completed

Phase 2

Conditions

REM Sleep Behavior Disorder

Treatments

Drug: Placebo

Drug: Clonazepam

Study type

Interventional

Funder types

Other

Identifiers

NCT02312908

14172EuiYakAn178

Details and patient eligibility

About

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).

Full 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.

Enrollment

40 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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