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

NCT02312908 | Completed Phase 2

• 1 other identifier: 14172EuiYakAn178
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

REM Sleep Behavior Disorder

Keywords

REM Sleep Behavior Disorder; Parkinson Disease; Placebos; Randomized Controlled Trial; Double-Blind Method; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Four weeks (plus or minus 3 days)

Secondary Outcomes (5)

• Clinical Global Impression-Severity scale (CGI-S)

  Four weeks (plus or minus 3 days)

• Epworth Sleepiness Scale (ESS)

  Four weeks (plus or minus 3 days)

• Parkinson Disease Sleep Scale (PDSS)

  Four weeks (plus or minus 3 days)

• Montreal Cognitive Assessment (MoCA)

  Four weeks (plus or minus 3 days)

• Unified Parkinson's Disease Rating Scale (UPDRS)

  Four weeks (plus or minus 3 days)

Study Arms (2)

Clonazepam

EXPERIMENTAL

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

Drug: Clonazepam

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Clonazepam DRUG

For experimental treatment of RBD

Also known as: Rivotril

Clonazepam

Placebo DRUG

Placebo pill manufactured to mask clonazepam 0.5mg tablet

Also known as: Placebo tablet of Rivotril

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)?"

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Food and Drug Safety, Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (11)

• 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.

  PMID: 22447623 BACKGROUND

• 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.

  PMID: 21832215 BACKGROUND

• 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.

  PMID: 22322798 BACKGROUND

• 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.

  PMID: 16966533 BACKGROUND

• 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.

  PMID: 10607098 BACKGROUND

• 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.

  PMID: 10648440 BACKGROUND

• 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.

  PMID: 22171203 BACKGROUND

• 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.

  PMID: 20191945 BACKGROUND

• 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.

  PMID: 18398415 BACKGROUND

• 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.

  PMID: 22729987 BACKGROUND

• 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.

  PMID: 20561180 BACKGROUND

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Parkinson Disease

Interventions

Clonazepam

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Beom Seok Jeon, MD, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 25, 2016

Record last verified: 2016-04

Locations

KR (1)