Efficacy and Safety of Melatonin and Clonazepam for IRBD

REM Sleep Behavior Disorder Clinical Trial

Official title:

Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255642
• Other study ID #: 2017-03-011
• Status: Completed
• Phase: N/A
• Start date: November 9, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2021
• Source: Kyung Hee University Hospital at Gangdong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• REM Sleep Behavior Disorder

Intervention

Drug:
• Melatonin 2mg
4 weeks of 2mg prolonged release melatonin (Circadin)
• ClonazePAM 0.5 MG
4 weeks of 0.5mg clonazepam (Rivotril)

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. — View Citation

Iranzo A, Molinuevo JL, Santamaría J, Serradell M, Martí 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. — View 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. — View 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. — View 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. Review. — View Citation

Nardone R, Golaszewski S, Höller 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Global Impression of RBD symptom severity	Clinical Global Impression scale score provided by patient and caregiver.	4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Secondary	REM sleep behavior disorder symptom severity	REM sleep behavior disorder questionnaire-Hong Kong total score	4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Secondary	Sleep quality	Pittsburg Sleep Quality Index total score	4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Secondary	Depression	Beck depression inventory-II total score	4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg