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Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02768077
Recruitment Status : Unknown
Verified May 2016 by Kuhnil Pharmaceutical Co., Ltd..
Recruitment status was:  Enrolling by invitation
First Posted : May 11, 2016
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Kuhnil Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
This clinical study is a double-blind, randomized, placebo-controlled trial to investigate the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients, symptoms which have a significant impact on the quality of life of these patients.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Melatonin(Circadin®) Drug: Placebo Phase 4

Detailed Description:
After selecting patients who satisfied the inclusion criteria and were not disqualified by the exclusion criteria, through a double-blind procedure the patients are directed to orally take either the investigational drug melatonin or a placebo(allocation ratio 1:1) for 4 weeks, once daily, before going to sleep. The evaluation of efficacy and safety is performed at the first baseline and immediately after administering the drug for 4 weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Melatonin(Circadin®)
Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.
 Drug: Melatonin(Circadin®)
Other Name: Prolonged release melatonin 2mg
Placebo Comparator: Placebo
Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Variation in PSQI(Pittsburgh Sleep Quality Index) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]

Secondary Outcome Measures :
  1. Variations in UPDRS(Unified Parkinson Disease Rating Scale) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
  2. Variations in H & Y Scale(Hoehn and Yahr Scale) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
  3. Variations in NMSS(Non-Motor Symptom assessment Scale) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
  4. Variations in ESS(The Epworth Sleepiness Scale) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
  5. Variations in PDSS(The Parkinson's Disease Sleep Scale) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
  6. Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
  7. Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]

Other Outcome Measures:
  1. Variations in CGI(Clinical Global Impression) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
  2. Variations in PGI(Patient Global Impression) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
  3. Number of subjects with adverse events [ Time Frame: 4 weeks of drug treatment ]
  4. Number of subjects with serious adverse events [ Time Frame: 4 weeks of drug treatment ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who meet the clinical criteria for idiopathic Parkinson's disease (United Kingdom Parkinson's Disease Brain Bank Criteria)
  2. Patients who complain of sleep disturbances such as insomnia, REM sleep behavior disorder, excessive daytime sleepiness (EDS), etc.
  3. Patients who have received drug treatment for at least 6 months since their diagnosis
  4. Male or female patient aged 55 or older
  5. Patients who have given voluntary consent after understanding the content of the clinical trial (in the case of elderly patients aged 70 or older, consent must be received from both the subject and the his or her legal representative)

Exclusion Criteria:

  1. Patients with a serious cognitive disorder, behavioral disorder, or mental illness

  2. Patients with a serious medical disease

    • Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, moderate or more severe liver disease
    • Patients with un-controlled high blood pressure or diabetes
  3. Patients who have taken another drug under clinical trial within 4 weeks prior to registering for this clinical trial, or patients who are pregnant or breastfeeding
  4. Patients who have a history of hypersensitivity to the investigational drug or a drug similar in component or who have had heavy metal poisoning
  5. Patients who are taking drugs which could effect on sleep such as rivotril, quetiapine, lexapro, etc.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768077


Sponsors and Collaborators
Kuhnil Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Jisun Kim Soon Chun Hyang University Hospital, Department of Neurology
Principal Investigator: Jin Whan Cho Samsung Medical Center, Department of Neurology
Principal Investigator: Eungseok Oh Chungnam National University Hospital, Department of Neurology
Principal Investigator: Wooyoung Jang Gangneung Asan Hospital, Department of Neurology
Principal Investigator: Jinse Park Inje University Haeundae Paik Hospital, Department of Neurology
More Information
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Responsible Party: Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02768077     History of Changes
Other Study ID Numbers: Circadin-2015-07
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kuhnil Pharmaceutical Co., Ltd.:
melatonin
sleep disturbances

Additional relevant MeSH terms:
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Parkinson Disease
Dyssomnias
Sleep Wake Disorders
Parasomnias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
 Neurodegenerative Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants