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Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease

NCT02789592 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-06-03

No results posted yet for this study

Summary

The purpose of this study is to determine whether melatonin prolonged-release (PR) and clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD).

Conditions

  • REM Sleep Behavior Disorder
  • Parkinson Disease

Interventions

DRUG

Melatonin PR

For experimental treatment of RBD

DRUG

Clonazepam

For experimental treatment of RBD

DRUG

Melatonin PR placebo

Placebo pill manufactured to mask melatonin PR 2mg tablet

DRUG

Clonazepam placebo

Placebo pill manufactured to mask clonazepam 0.5mg tablet

Sponsors & Collaborators

  • Kuhnil Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Beomseok Jeon, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789592 on ClinicalTrials.gov