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

Sponsor

KIMJisun (Other)

Overall Status

Unknown status

CT.gov ID

NCT03258294

Collaborator

Kuhnil Pharmaceutical Co., Ltd. (Industry)

Enrollment

Arms

35.5

Anticipated Duration (Months)

Study Details

Study Description

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 Oral Tablet	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

Study Type:

Interventional

Anticipated Enrollment :

82 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

Actual Study Start Date :

Jan 13, 2016

Anticipated Primary Completion Date :

Dec 30, 2018

Anticipated Study Completion Date :

Dec 30, 2018

Arms and Interventions

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®)
Placebo Comparator: Placebo Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.	Drug: Placebo Oral Tablet

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®)

Placebo Comparator: Placebo

Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.

Drug: Placebo Oral Tablet

Outcome Measures

Primary Outcome Measures

Variation in PSQI(Pittsburgh Sleep Quality Index) [Baseline and immediately after administering the drug for 4 weeks]
Variation in PSQI before and immediately after the administration of the drug

Secondary Outcome Measures

Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire) [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 ESS(The Epworth Sleepiness Scale) [Baseline and immediately after administering the drug for 4 weeks]
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 PDQ-39(The 39-Item Parkinson's Disease Questionnaire) [Baseline and immediately after administering the drug for 4 weeks]

Other Outcome Measures

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]
Number of subjects with adverse events [4 weeks of drug treatment]
Number of subjects with serious adverse events [4 weeks of drug treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding
Patients who have a history of hypersensitivity to the investigational products or a drug similar in component or who have had heavy metal poisoning

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

KIMJisun
Kuhnil Pharmaceutical Co., Ltd.

Investigators

Principal Investigator: Jisun Kim, 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