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Trial · NCT03255642

Efficacy and Safety of Melatonin and Clonazepam for IRBD

NCT03255642, Not applicable, Completed, Kyung Hee University Hospital at Gangdong

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy and Safety of Melatonin and Clonazepam for IRBD. Trials, record NCT03255642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03255642

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Efficacy and Safety of Melatonin and Clonazepam for IRBD
NCT number
NCT03255642
Status
Completed
Phases
Not applicable
Enrollment
34 participants, actual
Lead sponsor
Kyung Hee University Hospital at Gangdong
Conditions
REM Sleep Behavior Disorder
Interventions
Melatonin 2mg, ClonazePAM 0.5 MG
First posted
2017-08-21
Last updated
2021-02-21

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAutomated REM without atonia index4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mgPercentage seconds with chin EMG amplitude\<1uV/ Total REM seconds.
SecondaryClinical Global Impression of RBD symptom severity4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mgClinical Global Impression scale score provided by patient and caregiver.
SecondaryREM sleep behavior disorder symptom severity4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mgREM sleep behavior disorder questionnaire-Hong Kong total score
SecondarySleep quality4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mgPittsburg Sleep Quality Index total score
SecondaryDepression4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mgBeck depression inventory-II total score

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
16781987BACKGROUNDPubMed
20561180BACKGROUNDPubMed
23098778BACKGROUNDPubMed
23352028BACKGROUNDPubMed
23542221BACKGROUNDPubMed
25454845BACKGROUNDPubMed
35141811DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03255642

GET https://conductscience.org/api/trials/v1/NCT03255642/registered