Back to resultsEffect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Melatonin(Circadin®)
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring melatonin, sleep disturbances
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Melatonin(Circadin®)
Placebo
Arm Description
Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.
Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.
Outcomes
Primary Outcome Measures
Variation in PSQI(Pittsburgh Sleep Quality Index)
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)
Variations in PDSS(The Parkinson's Disease Sleep Scale)
Variations in ESS(The Epworth Sleepiness Scale)
Variations in UPDRS(Unified Parkinson Disease Rating Scale)
Variations in H & Y Scale(Hoehn and Yahr Scale)
Variations in NMSS(Non-Motor Symptom assessment Scale)
Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)
Full Information
NCT ID
NCT03258294
First Posted
August 20, 2017
Last Updated
August 20, 2017
Sponsor
KIMJisun
Collaborators
Kuhnil Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03258294
Brief Title
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease
Official Title
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2016 (Actual)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
December 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
KIMJisun
Collaborators
Kuhnil Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
melatonin, sleep disturbances
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melatonin(Circadin®)
Arm Type
Experimental
Arm Description
Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Melatonin(Circadin®)
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Variation in PSQI(Pittsburgh Sleep Quality Index)
Description
Variation in PSQI before and immediately after the administration of the drug
Time Frame
Baseline and immediately after administering the drug for 4 weeks
Secondary Outcome Measure Information:
Title
Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)
Time Frame
Baseline and immediately after administering the drug for 4 weeks
Title
Variations in PDSS(The Parkinson's Disease Sleep Scale)
Time Frame
Baseline and immediately after administering the drug for 4 weeks
Title
Variations in ESS(The Epworth Sleepiness Scale)
Time Frame
Baseline and immediately after administering the drug for 4 weeks
Title
Variations in UPDRS(Unified Parkinson Disease Rating Scale)
Time Frame
Baseline and immediately after administering the drug for 4 weeks
Title
Variations in H & Y Scale(Hoehn and Yahr Scale)
Time Frame
Baseline and immediately after administering the drug for 4 weeks
Title
Variations in NMSS(Non-Motor Symptom assessment Scale)
Time Frame
Baseline and immediately after administering the drug for 4 weeks
Title
Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)
Time Frame
Baseline and immediately after administering the drug for 4 weeks
Other Pre-specified Outcome Measures:
Title
Variations in CGI(Clinical Global Impression)
Time Frame
Baseline and immediately after administering the drug for 4 weeks
Title
Variations in PGI(Patient Global Impression)
Time Frame
Baseline and immediately after administering the drug for 4 weeks
Title
Number of subjects with adverse events
Time Frame
4 weeks of drug treatment
Title
Number of subjects with serious adverse events
Time Frame
4 weeks of drug treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jisun Kim
Organizational Affiliation
Samsung Medical Center, Department of Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eungseok Oh
Organizational Affiliation
Chungnam National University Hospital, Department of Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wooyoung Jang
Organizational Affiliation
Gangneung Asan Hospital, Department of Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jinse Park
Organizational Affiliation
Inje University Haeundae Paik Hospital, Department of Neurology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease
We'll reach out to this number within 24 hrs