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Efficacy and Safety of Melatonin and Clonazepam for IRBD

Primary Purpose

REM Sleep Behavior Disorder

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Melatonin 2mg
ClonazePAM 0.5 MG
Sponsored by
Kyung Hee University Hospital at Gangdong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for REM Sleep Behavior Disorder focused on measuring Clonazepam, Melatonin, Treatment, REM Sleep Behavior Disorder

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • REM sleep behavior disorder (ICSD-3 criteria)

Exclusion Criteria:

  • Neurological disorder including epilepsy or stroke
  • History of psychiatric illness
  • Neurodegenerative disease including dementia or parkinsonism.
  • Medication affecting sleep within 1 month
  • Intake of melatonin or clonazepam within 1 week.
  • Unable to complete questionnaires

Sites / Locations

  • Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Melatonin 2mg

ClonazePAM 0.5 MG

Arm Description

4 weeks of 2mg of prolonged release Melatonin

4 weeks of 0.5mg of rivotril

Outcomes

Primary Outcome Measures

Automated REM without atonia index
Percentage seconds with chin EMG amplitude<1uV/ Total REM seconds.

Secondary Outcome Measures

Clinical Global Impression of RBD symptom severity
Clinical Global Impression scale score provided by patient and caregiver.
REM sleep behavior disorder symptom severity
REM sleep behavior disorder questionnaire-Hong Kong total score
Sleep quality
Pittsburg Sleep Quality Index total score
Depression
Beck depression inventory-II total score

Full Information

First Posted
May 29, 2017
Last Updated
February 18, 2021
Sponsor
Kyung Hee University Hospital at Gangdong
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1. Study Identification

Unique Protocol Identification Number
NCT03255642
Brief Title
Efficacy and Safety of Melatonin and Clonazepam for IRBD
Official Title
Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyung Hee University Hospital at Gangdong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.
Detailed Description
This study is open-label parallel trial with 4 weeks treatment with slow-release melatonin (Circadin) or with clonazepam (Rivotril). Polysomnography, symptom diary and questionnaire (Clinical Global Impression, RBDQ-HK, PSQI, ESS, SSS, ISI, BDI-II) will be performed before and after 4 weeks of each medications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
REM Sleep Behavior Disorder
Keywords
Clonazepam, Melatonin, Treatment, REM Sleep Behavior Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Open-label study
Masking
Outcomes Assessor
Masking Description
Mask treatment arm when analyzing polysomnography.
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin 2mg
Arm Type
Active Comparator
Arm Description
4 weeks of 2mg of prolonged release Melatonin
Arm Title
ClonazePAM 0.5 MG
Arm Type
Placebo Comparator
Arm Description
4 weeks of 0.5mg of rivotril
Intervention Type
Drug
Intervention Name(s)
Melatonin 2mg
Other Intervention Name(s)
Circadin
Intervention Description
4 weeks of 2mg prolonged release melatonin (Circadin)
Intervention Type
Drug
Intervention Name(s)
ClonazePAM 0.5 MG
Other Intervention Name(s)
Rivotril
Intervention Description
4 weeks of 0.5mg clonazepam (Rivotril)
Primary Outcome Measure Information:
Title
Automated REM without atonia index
Description
Percentage seconds with chin EMG amplitude<1uV/ Total REM seconds.
Time Frame
4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Secondary Outcome Measure Information:
Title
Clinical Global Impression of RBD symptom severity
Description
Clinical Global Impression scale score provided by patient and caregiver.
Time Frame
4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Title
REM sleep behavior disorder symptom severity
Description
REM sleep behavior disorder questionnaire-Hong Kong total score
Time Frame
4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Title
Sleep quality
Description
Pittsburg Sleep Quality Index total score
Time Frame
4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Title
Depression
Description
Beck depression inventory-II total score
Time Frame
4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: REM sleep behavior disorder (ICSD-3 criteria) Exclusion Criteria: Neurological disorder including epilepsy or stroke History of psychiatric illness Neurodegenerative disease including dementia or parkinsonism. Medication affecting sleep within 1 month Intake of melatonin or clonazepam within 1 week. Unable to complete questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Chul Shin, M.D. Ph.D.
Organizational Affiliation
KyungHee University Hospital at Gangdong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05269
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23098778
Citation
Ferri R, Marelli S, Ferini-Strambi L, Oldani A, Colli F, Schenck CH, Zucconi M. An observational clinical and video-polysomnographic study of the effects of clonazepam in REM sleep behavior disorder. Sleep Med. 2013 Jan;14(1):24-9. doi: 10.1016/j.sleep.2012.09.009. Epub 2012 Oct 23.
Results Reference
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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
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PubMed Identifier
23352028
Citation
McCarter SJ, Boswell CL, St Louis EK, Dueffert LG, Slocumb N, Boeve BF, Silber MH, Olson EJ, Tippmann-Peikert M. Treatment outcomes in REM sleep behavior disorder. Sleep Med. 2013 Mar;14(3):237-42. doi: 10.1016/j.sleep.2012.09.018. Epub 2013 Jan 23.
Results Reference
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PubMed Identifier
25454845
Citation
McGrane IR, Leung JG, St Louis EK, Boeve BF. Melatonin therapy for REM sleep behavior disorder: a critical review of evidence. Sleep Med. 2015 Jan;16(1):19-26. doi: 10.1016/j.sleep.2014.09.011. Epub 2014 Oct 13.
Results Reference
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PubMed Identifier
23542221
Citation
Nardone R, Golaszewski S, Holler Y, Christova M, Trinka E, Brigo F. Neurophysiological insights into the pathophysiology of REM sleep behavior disorders: a review. Neurosci Res. 2013 Jul;76(3):106-12. doi: 10.1016/j.neures.2013.03.009. Epub 2013 Mar 28.
Results Reference
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PubMed Identifier
16781987
Citation
Iranzo A, Molinuevo JL, Santamaria J, Serradell M, Marti MJ, Valldeoriola F, Tolosa E. Rapid-eye-movement sleep behaviour disorder as an early marker for a neurodegenerative disorder: a descriptive study. Lancet Neurol. 2006 Jul;5(7):572-7. doi: 10.1016/S1474-4422(06)70476-8.
Results Reference
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PubMed Identifier
35141811
Citation
Byun JI, Shin YY, Seong YA, Yoon SM, Hwang KJ, Jung YJ, Cha KS, Jung KY, Shin WC. Comparative efficacy of prolonged-release melatonin versus clonazepam for isolated rapid eye movement sleep behavior disorder. Sleep Breath. 2023 Mar;27(1):309-318. doi: 10.1007/s11325-022-02572-8. Epub 2022 Feb 9.
Results Reference
derived

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Efficacy and Safety of Melatonin and Clonazepam for IRBD

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