NCT02836743

Brief Summary

To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

July 13, 2016

Last Update Submit

April 26, 2017

Conditions

REM Sleep Behavior Disorder

Keywords

REM sleep behavior disorderMelatonin

Outcome Measures

Primary Outcomes (2)

  • Changes in Clinical Global Impression scale

    baseline and 4 weeks

  • Changes in RBDQ-HK score (RBD questionnaire-HK)

    Baseline and 4 weeks

Secondary Outcomes (5)

  • Sleep quality questionnaire

    after taking the treatment for 4 weeks

  • Sleepiness questionnaire

    after taking the treatment for 4 weeks

  • Quality of life questionnaire

    after taking the treatment for 4 weeks

  • Changes in Dream enactment behavior frequency described in sleep diary

    Baseline and 4 weeks

  • Drug adverse effect

    4 weeks

Study Arms (3)

Circadin 2mg

EXPERIMENTAL

low-dose (2mg) slow-release melatonin for 1 month.

Drug: Circadin

Circadin 6mg

EXPERIMENTAL

high-dose (6mg) slow-release melatonin for 1 month.

Drug: Circadin

Placebo

PLACEBO COMPARATOR

Administer placebo pills with identical morphology

Drug: Placebo

Interventions

CircadinDRUG

Slow-release melatonin

Also known as: slow-release melatonin
Circadin 2mgCircadin 6mg
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (4)

  • Takeuchi N, Uchimura N, Hashizume Y, Mukai M, Etoh Y, Yamamoto K, Kotorii T, Ohshima H, Ohshima M, Maeda H. Melatonin therapy for REM sleep behavior disorder. Psychiatry Clin Neurosci. 2001 Jun;55(3):267-9. doi: 10.1046/j.1440-1819.2001.00854.x.

    PMID: 11422870BACKGROUND

  • Kunz D, Bes F. Melatonin as a therapy in REM sleep behavior disorder patients: an open-labeled pilot study on the possible influence of melatonin on REM-sleep regulation. Mov Disord. 1999 May;14(3):507-11. doi: 10.1002/1531-8257(199905)14:33.0.co;2-8.

    PMID: 10348479BACKGROUND

  • Boeve BF, Silber MH, Ferman TJ. Melatonin for treatment of REM sleep behavior disorder in neurologic disorders: results in 14 patients. Sleep Med. 2003 Jul;4(4):281-4. doi: 10.1016/s1389-9457(03)00072-8.

    PMID: 14592300BACKGROUND

  • 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: 20561180BACKGROUND

MeSH Terms

Conditions

REM Sleep Behavior Disorder

Interventions

Melatonin

Condition Hierarchy (Ancestors)

REM Sleep ParasomniasParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Ki-Young Jung, M.D. Ph.D.

CONTACT

+82-2-2072-4988jungky10@gmail.com

Jung-Ick Byun, M.D.

CONTACT

+82-2-440-6254mr830611@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 19, 2016

Study Start

January 1, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

KR(1)