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

Arm | Intervention/treatment |
---|---|
Experimental: Melatonin(Circadin®)
Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.
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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.
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Drug: Placebo |
- Variation in PSQI(Pittsburgh Sleep Quality Index) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
- Variations in UPDRS(Unified Parkinson Disease Rating Scale) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
- Variations in H & Y Scale(Hoehn and Yahr Scale) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
- Variations in NMSS(Non-Motor Symptom assessment Scale) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
- Variations in ESS(The Epworth Sleepiness Scale) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
- Variations in PDSS(The Parkinson's Disease Sleep Scale) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
- Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
- Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
- Variations in CGI(Clinical Global Impression) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
- Variations in PGI(Patient Global Impression) [ Time Frame: Baseline and immediately after administering the drug for 4 weeks ]
- Number of subjects with adverse events [ Time Frame: 4 weeks of drug treatment ]
- Number of subjects with serious adverse events [ Time Frame: 4 weeks of drug treatment ]

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who meet the clinical criteria for idiopathic Parkinson's disease (United Kingdom Parkinson's Disease Brain Bank Criteria)
- Patients who complain of sleep disturbances such as insomnia, REM sleep behavior disorder, excessive daytime sleepiness (EDS), etc.
- Patients who have received drug treatment for at least 6 months since their diagnosis
- Male or female patient aged 55 or older
- 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:
- Patients with a serious cognitive disorder, behavioral disorder, or mental illness
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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
- 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
- Patients who have a history of hypersensitivity to the investigational drug or a drug similar in component or who have had heavy metal poisoning
- Patients who are taking drugs which could effect on sleep such as rivotril, quetiapine, lexapro, etc.

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
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 |
Responsible Party: | Kuhnil Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT02768077 |
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 |
melatonin sleep disturbances |
Parkinson Disease Dyssomnias Parasomnias Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies |
Neurodegenerative Diseases Sleep Wake Disorders Mental Disorders Melatonin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |