Efficacy and Safety of Melatonin and Clonazepam for IRBD

NCT03255642 | Completed DMC

• 1 other identifier: 2017-03-011
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

REM Sleep Behavior Disorder

Keywords

Clonazepam; Melatonin; Treatment; REM Sleep Behavior Disorder

Outcome Measures

Primary Outcomes (1)

• Automated REM without atonia index

  Percentage seconds with chin EMG amplitude\<1uV/ Total REM seconds.

  4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

Secondary Outcomes (4)

• Clinical Global Impression of RBD symptom severity

  4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

• REM sleep behavior disorder symptom severity

  4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

• Sleep quality

  4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

• Depression

  4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

Study Arms (2)

Melatonin 2mg

ACTIVE COMPARATOR

4 weeks of 2mg of prolonged release Melatonin

Drug: Melatonin 2mg

ClonazePAM 0.5 MG

PLACEBO COMPARATOR

4 weeks of 0.5mg of rivotril

Drug: ClonazePAM 0.5 MG

Interventions

Melatonin 2mg DRUG

4 weeks of 2mg prolonged release melatonin (Circadin)

Also known as: Circadin

Melatonin 2mg

ClonazePAM 0.5 MG DRUG

4 weeks of 0.5mg clonazepam (Rivotril)

Also known as: Rivotril

ClonazePAM 0.5 MG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• REM sleep behavior disorder (ICSD-3 criteria)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyung Hee University Hospital at Gangdong: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, 05269, South Korea

Location

Related Publications (7)

• 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.

  PMID: 23098778 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

• 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.

  PMID: 23352028 BACKGROUND

• 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.

  PMID: 25454845 BACKGROUND

• 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.

  PMID: 23542221 BACKGROUND

• 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.

  PMID: 16781987 BACKGROUND

• 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.

  PMID: 35141811 DERIVED

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Interventions

Melatonin; Clonazepam

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Benzodiazepinones; Benzodiazepines; Benzazepines

Study Officials

• Won Chul Shin, M.D. Ph.D.

  KyungHee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Mask treatment arm when analyzing polysomnography.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective Randomized Open-label study

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: August 21, 2017
• Study Start: November 9, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

KR (1)