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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.
Full 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.
Enrollment
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Inclusion criteria
Exclusion criteria
Patients with a serious cognitive disorder, behavioral disorder, or mental illness
Patients with a serious medical disease
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.
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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