Status:

COMPLETED

Efficacy and Safety of Melatonin and Clonazepam for IRBD

Lead Sponsor:

Kyung Hee University Hospital at Gangdong

Conditions:

REM Sleep Behavior Disorder

Eligibility:

All Genders

50+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • REM sleep behavior disorder (ICSD-3 criteria)

Exclusion

  • 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

Key Trial Info

Start Date :

November 9 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2020

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT03255642

Start Date

November 9 2017

End Date

December 1 2020

Last Update

February 21 2021

Active Locations (1)

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1

Kyung Hee University Hospital at Gangdong

Seoul, South Korea, 05269