Status:
UNKNOWN
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease
Lead Sponsor:
KIMJisun
Collaborating Sponsors:
Kuhnil Pharmaceutical Co., Ltd.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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 ha...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2018
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03258294
Start Date
January 13 2016
End Date
December 30 2018
Last Update
August 23 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.