- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03258294
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease
August 20, 2017 updated by: KIMJisun
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
82
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Melatonin(Circadin®)
Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.
|
|
Placebo Comparator: Placebo
Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation in PSQI(Pittsburgh Sleep Quality Index)
Time Frame: Baseline and immediately after administering the drug for 4 weeks
|
Variation in PSQI before and immediately after the administration of the drug
|
Baseline and immediately after administering the drug for 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)
Time Frame: Baseline and immediately after administering the drug for 4 weeks
|
Baseline and immediately after administering the drug for 4 weeks
|
Variations in PDSS(The Parkinson's Disease Sleep Scale)
Time Frame: Baseline and immediately after administering the drug for 4 weeks
|
Baseline and immediately after administering the drug for 4 weeks
|
Variations in ESS(The Epworth Sleepiness Scale)
Time Frame: Baseline and immediately after administering the drug for 4 weeks
|
Baseline and immediately after administering the drug for 4 weeks
|
Variations in UPDRS(Unified Parkinson Disease Rating Scale)
Time Frame: Baseline and immediately after administering the drug for 4 weeks
|
Baseline and immediately after administering the drug for 4 weeks
|
Variations in H & Y Scale(Hoehn and Yahr Scale)
Time Frame: Baseline and immediately after administering the drug for 4 weeks
|
Baseline and immediately after administering the drug for 4 weeks
|
Variations in NMSS(Non-Motor Symptom assessment Scale)
Time Frame: Baseline and immediately after administering the drug for 4 weeks
|
Baseline and immediately after administering the drug for 4 weeks
|
Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)
Time Frame: Baseline and immediately after administering the drug for 4 weeks
|
Baseline and immediately after administering the drug for 4 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Variations in CGI(Clinical Global Impression)
Time Frame: Baseline and immediately after administering the drug for 4 weeks
|
Baseline and immediately after administering the drug for 4 weeks
|
Variations in PGI(Patient Global Impression)
Time Frame: Baseline and immediately after administering the drug for 4 weeks
|
Baseline and immediately after administering the drug for 4 weeks
|
Number of subjects with adverse events
Time Frame: 4 weeks of drug treatment
|
4 weeks of drug treatment
|
Number of subjects with serious adverse events
Time Frame: 4 weeks of drug treatment
|
4 weeks of drug treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jisun Kim, Samsung Medical Center, Department of Neurology
- Principal Investigator: Eungseok Oh, Chungnam National University Hospital, Department of Neurology
- Principal Investigator: Wooyoung Jang, Gangneung Asan Hospital, Department of Neurology
- Principal Investigator: Jinse Park, Inje University Haeundae Paik Hospital, Department of Neurology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2016
Primary Completion (Anticipated)
December 30, 2018
Study Completion (Anticipated)
December 30, 2018
Study Registration Dates
First Submitted
August 20, 2017
First Submitted That Met QC Criteria
August 20, 2017
First Posted (Actual)
August 23, 2017
Study Record Updates
Last Update Posted (Actual)
August 23, 2017
Last Update Submitted That Met QC Criteria
August 20, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Sleep Wake Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Dyssomnias
- Parasomnias
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Protective Agents
- Antioxidants
- Melatonin
Other Study ID Numbers
- 2015-09-098-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Shanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaRecruitingIdiopathic Parkinson's DiseaseChina
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
AbbVieActive, not recruitingParkinson's Disease (PD)United States, Australia
-
AbbVieCompletedParkinson's Disease (PD)United States, Australia
-
BlueRock TherapeuticsMemorial Sloan Kettering Cancer CenterActive, not recruitingAdvanced Parkinson's DiseaseUnited States, Canada
Clinical Trials on Placebo Oral Tablet
-
EstetraICON Clinical ResearchCompletedVasomotor Symptoms | Menopausal SymptomsUnited States, Canada
-
EicOsis Human Health Inc.RecruitingHealthy SubjectsNew Zealand
-
University of OxfordNovo Nordisk A/SRecruitingDiabetes Mellitus, Type 2United Kingdom
-
Fulcrum TherapeuticsTerminated
-
EicOsis Human Health Inc.CompletedHealthy AdultsUnited States
-
Harmony Biosciences, LLCActive, not recruitingMyotonic Dystrophy 1 | Excessive Daytime SleepinessUnited States, Canada
-
Syntrix Biosystems, Inc.National Institute on Drug Abuse (NIDA); DF/Net ResearchCompletedDiabetic Neuropathies | Neuropathic Pain | Pain, ChronicUnited States
-
The Mind Research NetworkTerminatedSmoking Cessation | Tobacco Use DisorderUnited States
-
Cara Therapeutics, Inc.CompletedChronic Kidney Diseases | PruritusUnited States
-
Sunshine Lake Pharma Co., Ltd.CompletedChronic Hepatitis CChina