Efficacy and Safety of Melatonin and Clonazepam for IRBD

February 18, 2021 updated by: Won Chul Shin, Kyung Hee University Hospital at Gangdong

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

This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05269
        • Kyung Hee University Hospital at Gangdong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Melatonin 2mg
4 weeks of 2mg of prolonged release Melatonin
Drug: Melatonin 2mg
4 weeks of 2mg prolonged release melatonin (Circadin)
Other Names:
  • Circadin
Placebo Comparator: ClonazePAM 0.5 MG
4 weeks of 0.5mg of rivotril
Drug: ClonazePAM 0.5 MG
4 weeks of 0.5mg clonazepam (Rivotril)
Other Names:
  • Rivotril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Automated REM without atonia index
Time Frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Percentage seconds with chin EMG amplitude<1uV/ Total REM seconds.
4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyung Hee University Hospital at Gangdong

Investigators

  • Principal Investigator: Won Chul Shin, M.D. Ph.D., Kyunghee University Hospital at Gangdong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2017

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 21, 2017

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 18, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-03-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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