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

Phase 4

• Conditions: Parkinson's Disease
• Interventions: Drug: Melatonin(Circadin®); Drug: Placebo

• Registration Number: NCT02768077
• Lead Sponsor: Kuhnil Pharmaceutical Co., Ltd.

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.

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 Timeline

• Study Start: 2016-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-18
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin(Circadin®)	Melatonin(Circadin®)	Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.
Placebo	Placebo	Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.

Primary Outcome Measures

Name	Time	Method
Variation in PSQI(Pittsburgh Sleep Quality Index)	Baseline and immediately after administering the drug for 4 weeks

Secondary Outcome Measures

Name	Time	Method
Variations in UPDRS(Unified Parkinson Disease Rating 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 H & Y Scale(Hoehn and Yahr 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