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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Melatonin(Circadin®)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin(Circadin®)<br>Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks. | Drug: Melatonin(Circadin®)<br> <br> * Other names: Prolonged release melatonin 2mg;|
| Placebo Comparator: Placebo<br>Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in PSQI(Pittsburgh Sleep Quality Index) |  | Baseline and immediately after administering the drug for 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, sleep disturbances