14172EuiYakAn178

About this trial

Last updated 9 years ago

Study ID

14172EuiYakAn178

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

30+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 9 years ago

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).

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

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