Clinical trial NCT02768077: Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease
Official title: Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: melatonin
sleep disturbances
Lead sponsor: Kuhnil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Variation in PSQI(Pittsburgh Sleep Quality Index)
timeFrame: Baseline and immediately after administering the drug for 4 weeks
Secondary outcomes:
measure: Variations in UPDRS(Unified Parkinson Disease Rating Scale)
timeFrame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in H & Y Scale(Hoehn and Yahr Scale)
timeFrame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in NMSS(Non-Motor Symptom assessment Scale)
timeFrame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in ESS(The Epworth Sleepiness Scale)
timeFrame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in PDSS(The Parkinson's Disease Sleep Scale)
timeFrame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)
timeFrame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)
timeFrame: Baseline and immediately after administering the drug for 4 weeks
Other outcomes:
measure: Variations in CGI(Clinical Global Impression)
timeFrame: Baseline and immediately after administering the drug for 4 weeks
measure: Variations in PGI(Patient Global Impression)
timeFrame: Baseline and immediately after administering the drug for 4 weeks
measure: Number of subjects with adverse events
timeFrame: 4 weeks of drug treatment
measure: Number of subjects with serious adverse events
timeFrame: 4 weeks of drug treatment
Locations:
Study officials:
affiliation: Soon Chun Hyang University Hospital, Department of Neurology
name: Jisun Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center, Department of Neurology
name: Jin Whan Cho
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National University Hospital, Department of Neurology
name: Eungseok Oh
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangneung Asan Hospital, Department of Neurology
name: Wooyoung Jang
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Haeundae Paik Hospital, Department of Neurology
name: Jinse Park
role: PRINCIPAL_INVESTIGATOR
References: