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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: REM Sleep Behavior Disorder

Intervention: Clonazepam (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Beom Seok Jeon, MD, Ph.D, Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Han-joon Kim, MD, Ph.D, Phone: +82-2-2072-1219, Email: movement@snu.ac.kr

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical Global Impression-Improvement scale (CGI-I)

Secondary outcome:

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)

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 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.

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Han-joon Kim, MD, Ph.D, Phone: +82-2-2072-1219, Email: movement@snu.ac.kr

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Han-joon Kim, MD, Ph.D, Phone: +82-2-2072-1219, Email: movment@snu.ac.kr
Chae-won Shin, MD, Phone: +82-2-2072-1219, Email: chroma0202@gmail.com
Han-joon Kim, MD, Ph.D, Sub-Investigator
Chae-won Shin, MD, Sub-Investigator
Beom Seok Jeon, MD, Ph.D, Principal Investigator
Additional Information

Related publications:

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. Review.

Sixel-Döring 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.

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.

Gagnon JF, Postuma RB, Montplaisir J. Update on the pharmacology of REM sleep behavior disorder. Neurology. 2006 Sep 12;67(5):742-7.

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.

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.

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.

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.

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. Review.

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.

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.

Starting date: March 2015
Last updated: May 28, 2015

Page last updated: August 23, 2015

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