search
Back to results

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

Primary Purpose

REM Sleep Behavior Disorder

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clonazepam
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for REM Sleep Behavior Disorder focused on measuring REM Sleep Behavior Disorder, Parkinson Disease, Placebos, Randomized Controlled Trial, Double-Blind Method, Clinical Trial

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clonazepam

Placebo

Arm Description

Clonazepam 0.5 mg 1 Tablet by mouth, 1/day before sleeping for 4 weeks

Placebo 1 Tablet by mouth, 1/day before sleeping for 4 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Global Impression-Severity scale (CGI-S)
Epworth Sleepiness Scale (ESS)
Parkinson Disease Sleep Scale (PDSS)
Montreal Cognitive Assessment (MoCA)
Unified Parkinson's Disease Rating Scale (UPDRS)

Full Information

First Posted
December 5, 2014
Last Updated
April 21, 2016
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT02312908
Brief Title
Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism
Official Title
Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism: a Prospective, Randomized, Double-blind and Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
REM Sleep Behavior Disorder
Keywords
REM Sleep Behavior Disorder, Parkinson Disease, Placebos, Randomized Controlled Trial, Double-Blind Method, Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clonazepam
Arm Type
Experimental
Arm Description
Clonazepam 0.5 mg 1 Tablet by mouth, 1/day before sleeping for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 Tablet by mouth, 1/day before sleeping for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Clonazepam
Other Intervention Name(s)
Rivotril
Intervention Description
For experimental treatment of RBD
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo tablet of Rivotril
Intervention Description
Placebo pill manufactured to mask clonazepam 0.5mg tablet
Primary Outcome Measure Information:
Title
Clinical Global Impression-Improvement scale (CGI-I)
Description
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.
Time Frame
Four weeks (plus or minus 3 days)
Secondary Outcome Measure Information:
Title
Clinical Global Impression-Severity scale (CGI-S)
Time Frame
Four weeks (plus or minus 3 days)
Title
Epworth Sleepiness Scale (ESS)
Time Frame
Four weeks (plus or minus 3 days)
Title
Parkinson Disease Sleep Scale (PDSS)
Time Frame
Four weeks (plus or minus 3 days)
Title
Montreal Cognitive Assessment (MoCA)
Time Frame
Four weeks (plus or minus 3 days)
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame
Four weeks (plus or minus 3 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beom Seok Jeon, MD, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22447623
Citation
Arnulf I. REM sleep behavior disorder: motor manifestations and pathophysiology. Mov Disord. 2012 May;27(6):677-89. doi: 10.1002/mds.24957. Epub 2012 Mar 22.
Results Reference
background
PubMed Identifier
21832215
Citation
Sixel-Doring F, Trautmann E, Mollenhauer B, Trenkwalder C. Associated factors for REM sleep behavior disorder in Parkinson disease. Neurology. 2011 Sep 13;77(11):1048-54. doi: 10.1212/WNL.0b013e31822e560e. Epub 2011 Aug 10.
Results Reference
background
PubMed Identifier
22322798
Citation
Postuma RB, Bertrand JA, Montplaisir J, Desjardins C, Vendette M, Rios Romenets S, Panisset M, Gagnon JF. Rapid eye movement sleep behavior disorder and risk of dementia in Parkinson's disease: a prospective study. Mov Disord. 2012 May;27(6):720-6. doi: 10.1002/mds.24939. Epub 2012 Feb 9.
Results Reference
background
PubMed Identifier
16966533
Citation
Gagnon JF, Postuma RB, Montplaisir J. Update on the pharmacology of REM sleep behavior disorder. Neurology. 2006 Sep 12;67(5):742-7. doi: 10.1212/01.wnl.0000233926.47469.73.
Results Reference
background
PubMed Identifier
10607098
Citation
Schenck CH, Hurwitz TD, Mahowald MW. Symposium: Normal and abnormal REM sleep regulation: REM sleep behaviour disorder: an update on a series of 96 patients and a review of the world literature. J Sleep Res. 1993 Dec;2(4):224-231. doi: 10.1111/j.1365-2869.1993.tb00093.x.
Results Reference
background
PubMed Identifier
10648440
Citation
Olson EJ, Boeve BF, Silber MH. Rapid eye movement sleep behaviour disorder: demographic, clinical and laboratory findings in 93 cases. Brain. 2000 Feb;123 ( Pt 2):331-9. doi: 10.1093/brain/123.2.331.
Results Reference
background
PubMed Identifier
22171203
Citation
Howell MJ, Arneson PA, Schenck CH. A novel therapy for REM sleep behavior disorder (RBD). J Clin Sleep Med. 2011 Dec 15;7(6):639-644A. doi: 10.5664/jcsm.1470.
Results Reference
background
PubMed Identifier
20191945
Citation
Aurora RN, Zak RS, Maganti RK, Auerbach SH, Casey KR, Chowdhuri S, Karippot A, Ramar K, Kristo DA, Morgenthaler TI; Standards of Practice Committee; American Academy of Sleep Medicine. Best practice guide for the treatment of REM sleep behavior disorder (RBD). J Clin Sleep Med. 2010 Feb 15;6(1):85-95. Erratum In: J Clin Sleep Med. 2010 Apr 15;6(2):table of contents.
Results Reference
background
PubMed Identifier
18398415
Citation
De Cock VC, Vidailhet M, Arnulf I. Sleep disturbances in patients with parkinsonism. Nat Clin Pract Neurol. 2008 May;4(5):254-66. doi: 10.1038/ncpneuro0775. Epub 2008 Apr 8.
Results Reference
background
PubMed Identifier
22729987
Citation
Postuma RB, Arnulf I, Hogl B, Iranzo A, Miyamoto T, Dauvilliers Y, Oertel W, Ju YE, Puligheddu M, Jennum P, Pelletier A, Wolfson C, Leu-Semenescu S, Frauscher B, Miyamoto M, Cochen De Cock V, Unger MM, Stiasny-Kolster K, Fantini ML, Montplaisir JY. A single-question screen for rapid eye movement sleep behavior disorder: a multicenter validation study. Mov Disord. 2012 Jun;27(7):913-6. doi: 10.1002/mds.25037. Epub 2012 May 30.
Results Reference
background
PubMed Identifier
20561180
Citation
Kunz D, Mahlberg R. A two-part, double-blind, placebo-controlled trial of exogenous melatonin in REM sleep behaviour disorder. J Sleep Res. 2010 Dec;19(4):591-6. doi: 10.1111/j.1365-2869.2010.00848.x.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs