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

April 21, 2016 updated by: BS Jeon, Seoul National University Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clonazepam
Clonazepam 0.5 mg 1 Tablet by mouth, 1/day before sleeping for 4 weeks
Drug: Clonazepam
For experimental treatment of RBD
Other Names:
  • Rivotril
Placebo Comparator: Placebo
Placebo 1 Tablet by mouth, 1/day before sleeping for 4 weeks
Drug: Placebo
Placebo pill manufactured to mask clonazepam 0.5mg tablet
Other Names:
  • Placebo tablet of Rivotril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four weeks (plus or minus 3 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression-Severity scale (CGI-S)
Time Frame: Four weeks (plus or minus 3 days)
Four weeks (plus or minus 3 days)
Epworth Sleepiness Scale (ESS)
Time Frame: Four weeks (plus or minus 3 days)
Four weeks (plus or minus 3 days)
Parkinson Disease Sleep Scale (PDSS)
Time Frame: Four weeks (plus or minus 3 days)
Four weeks (plus or minus 3 days)
Montreal Cognitive Assessment (MoCA)
Time Frame: Four weeks (plus or minus 3 days)
Four weeks (plus or minus 3 days)
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Four weeks (plus or minus 3 days)
Four weeks (plus or minus 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Food and Drug Safety, Korea

Investigators

  • Principal Investigator: Beom Seok Jeon, MD, Ph.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Estimate)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14172EuiYakAn178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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