Parkinson's Disease
Conditions
Keywords
melatonin, sleep disturbances
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.
Interventions
DRUGPlacebo Oral Tablet
Sponsors
Kuhnil Pharmaceutical Co., Ltd.
KIMJisun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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 investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding 4. Patients who have a history of hypersensitivity to the investigational products or a drug similar in component or who have had heavy metal poisoning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events | 4 weeks of drug treatment |
| Number of subjects with serious adverse events | 4 weeks of drug treatment |
| 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 |
Outcome results
None listed