Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease

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: Parkinson's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Melatonin(Circadin®)

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): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

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.	Drug: Melatonin(Circadin®); Other Names: Prolonged release melatonin 2mg
Placebo Comparator: Placebo; Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Variation in PSQI(Pittsburgh Sleep Quality Index)	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)	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
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

Other Outcome Measures

Outcome Measure	Time Frame
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
Number of subjects with adverse events	4 weeks of drug treatment
Number of subjects with serious adverse events	4 weeks of drug treatment

Collaborators and Investigators

• Sponsor: Kuhnil Pharmaceutical Co., Ltd.
• Investigators: 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; Principal Investigator: Jisun Kim, Soon Chun Hyang University Hospital, Department of Neurology; Principal Investigator: Jin Whan Cho, Samsung Medical Center, Department of Neurology

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 16, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: melatonin; sleep disturbances
• 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: Circadin-2015-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided