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Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study

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ClinicalTrials.gov Identifier: NCT02836743
Recruitment Status : Unknown
Verified April 2017 by Ki-Young Jung, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : July 19, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ki-Young Jung, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE July 13, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • Changes in Clinical Global Impression scale [ Time Frame: baseline and 4 weeks ]
  • Changes in RBDQ-HK score (RBD questionnaire-HK) [ Time Frame: Baseline and 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
  • Sleep quality questionnaire [ Time Frame: after taking the treatment for 4 weeks ]
    PSQI
  • Sleepiness questionnaire [ Time Frame: after taking the treatment for 4 weeks ]
    Epworth sleepiness scale
  • Quality of life questionnaire [ Time Frame: after taking the treatment for 4 weeks ]
    SF-36 version 2.
  • Changes in Dream enactment behavior frequency described in sleep diary [ Time Frame: Baseline and 4 weeks ]
  • Drug adverse effect [ Time Frame: 4 weeks ]
    adverse events and reason for drug withdrawal
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study
Official Title  ICMJE Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study
Brief Summary To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.
Detailed Description Investigators planned to administer low (2mg) and high (6mg) dose slow-release melatonin and the placebo for 4 weeks and evaluate Clinical Global Impression scale, RBD questionnaire, PSQI, Epworth sleepiness scale, and quality of life questionnaire (SF-36v2) before and after the treatment along with possible side effects and drug compliance.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE REM Sleep Behavior Disorder
Intervention  ICMJE
  • Drug: Circadin
    Slow-release melatonin
    Other Name: slow-release melatonin
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Circadin 2mg
    low-dose (2mg) slow-release melatonin for 1 month.
    Intervention: Drug: Circadin
  • Experimental: Circadin 6mg
    high-dose (6mg) slow-release melatonin for 1 month.
    Intervention: Drug: Circadin
  • Placebo Comparator: Placebo
    Administer placebo pills with identical morphology
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 18, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • REM sleep behavior disorder according to ICSD-3 criteria
  • No cognitive deficit or symptom of Parkinsonism
  • Those with written consent.

Exclusion Criteria:

  • who took medication (ex. clonazepam) for REM sleep behavior disorder
  • with degenerative neurologic disorder (ex. Parkinson's disease, Multiple System Atrophy, Lewy-body dementia, etc.)
  • who took medication that can affect REM sleep behavior disorder (anti-depressant: SSRI, TCA, MAO-inhibitor)
  • who is unable to answer questionnaires
  • who have hypersensitive reaction to medications
  • Pregnant women or breastfeeding
  • who are diagnosed with other parasomnia disorder
  • with severe medical disorder (severe liver failure, respiratory failure, heart failure, malignant tumor, etc.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02836743
Other Study ID Numbers  ICMJE 1505-084-673
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ki-Young Jung, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP