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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin(Circadin®) | Experimental | Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks. |
|
| Placebo | Placebo Comparator | Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin(Circadin®) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in PSQI(Pittsburgh Sleep Quality Index) | Baseline and immediately after administering the drug for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Variations in UPDRS(Unified Parkinson Disease Rating Scale) | Baseline and immediately after administering the drug for 4 weeks | |
| Variations in H & Y Scale(Hoehn and Yahr Scale) | Baseline and immediately after administering the drug for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Variations in CGI(Clinical Global Impression) | Baseline and immediately after administering the drug for 4 weeks | |
| Variations in PGI(Patient Global Impression) | Baseline and immediately after administering the drug for 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
Patients with a serious cognitive disorder, behavioral disorder, or mental illness
Patients with a serious medical disease
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo |
| Drug |
|
| Variations in NMSS(Non-Motor Symptom assessment Scale) | Baseline and immediately after administering the drug for 4 weeks |
| Variations in ESS(The Epworth Sleepiness Scale) | Baseline and immediately after administering the drug for 4 weeks |
| Variations in PDSS(The Parkinson's Disease Sleep Scale) | Baseline and immediately after administering the drug for 4 weeks |
| Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire) | Baseline and immediately after administering the drug for 4 weeks |
| Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire) | Baseline and immediately after administering the drug for 4 weeks |
| Number of subjects with adverse events | 4 weeks of drug treatment |
| Number of subjects with serious adverse events | 4 weeks of drug treatment |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |