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| Name | Class |
|---|---|
| Ministry of Food and Drug Safety, Korea | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonazepam | Experimental | Clonazepam 0.5 mg 1 Tablet by mouth, 1/day before sleeping for 4 weeks |
|
| Placebo | Placebo Comparator | Placebo 1 Tablet by mouth, 1/day before sleeping for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonazepam | Drug | For experimental treatment of RBD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beom Seok Jeon, MD, Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22447623 | Background | 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. | |
| 21832215 | 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. |
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| ID | Term |
|---|---|
| D020187 | REM Sleep Behavior Disorder |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002998 | Clonazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo | Drug | Placebo pill manufactured to mask clonazepam 0.5mg tablet |
|
|
| 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) |
| 22322798 | 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. |
| 16966533 | 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. |
| 10607098 | 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. |
| 10648440 | 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. |
| 22171203 | 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. |
| 20191945 | 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. |
| 18398415 | 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. |
| 22729987 | 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. |
| 20561180 | 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. |
| D001523 |
| Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |