Skip to main content
OpenTrials
Completed

NCT Number: NCT02312908

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

REM Sleep Behavior Disorder Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parasomnias Parkinson Disease Parkinsonian Disorders REM Sleep Parasomnias Sleep Wake Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clonazepam

Drug

For experimental treatment of RBD

Other names: Rivotril

Placebo

Drug

Placebo pill manufactured to mask clonazepam 0.5mg tablet

Other names: Placebo tablet of Rivotril

Primary outcomes

  1. Clinical Global Impression-Improvement scale (CGI-I)

    Time frame: 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 outcomes

  1. Clinical Global Impression-Severity scale (CGI-S)

    Time frame: Four weeks (plus or minus 3 days)

  2. Epworth Sleepiness Scale (ESS)

    Time frame: Four weeks (plus or minus 3 days)

  3. Parkinson Disease Sleep Scale (PDSS)

    Time frame: Four weeks (plus or minus 3 days)

  4. Montreal Cognitive Assessment (MoCA)

    Time frame: Four weeks (plus or minus 3 days)

  5. Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: Four weeks (plus or minus 3 days)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Food and Drug Safety, Korea

Registry information

Official study title

Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism: a Prospective, Randomized, Double-blind and Placebo-controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 9, 2014
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.