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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 May 2016 |
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Main ID: |
NCT02768077 |
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Date of registration:
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09/05/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease
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Scientific title:
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Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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100 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT02768077 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Contacts
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Name:
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Jinse Park |
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Address:
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Telephone:
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Email:
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Affiliation:
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Inje University Haeundae Paik Hospital, Department of Neurology |
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Name:
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Eungseok Oh |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chungnam National University Hospital, Department of Neurology |
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Name:
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Jisun Kim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Soon Chun Hyang University Hospital, Department of Neurology |
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Name:
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Wooyoung Jang |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gangneung Asan Hospital, Department of Neurology |
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Name:
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Jin Whan Cho |
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Address:
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Telephone:
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Email:
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Affiliation:
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Samsung Medical Center, Department of Neurology |
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Key inclusion & exclusion criteria
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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 drug under clinical trial within 4 weeks prior to
registering for this clinical trial, or patients who are pregnant or breastfeeding
4. Patients who have a history of hypersensitivity to the investigational drug or a drug
similar in component or who have had heavy metal poisoning
5. Patients who are taking drugs which could effect on sleep such as rivotril,
quetiapine, lexapro, etc.
Age minimum:
55 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Placebo
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Drug: Melatonin(Circadin®)
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Primary Outcome(s)
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Variation in PSQI(Pittsburgh Sleep Quality Index)
[Time Frame: Baseline and immediately after administering the drug for 4 weeks]
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Secondary Outcome(s)
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Variations in NMSS(Non-Motor Symptom assessment Scale)
[Time Frame: Baseline and immediately after administering the drug for 4 weeks]
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Variations in ESS(The Epworth Sleepiness Scale)
[Time Frame: Baseline and immediately after administering the drug for 4 weeks]
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Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)
[Time Frame: Baseline and immediately after administering the drug for 4 weeks]
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Variations in UPDRS(Unified Parkinson Disease Rating Scale)
[Time Frame: Baseline and immediately after administering the drug for 4 weeks]
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Variations in H & Y Scale(Hoehn and Yahr Scale)
[Time Frame: Baseline and immediately after administering the drug for 4 weeks]
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Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)
[Time Frame: Baseline and immediately after administering the drug for 4 weeks]
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Variations in PDSS(The Parkinson's Disease Sleep Scale)
[Time Frame: Baseline and immediately after administering the drug for 4 weeks]
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Secondary ID(s)
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Circadin-2015-07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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