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

Parkinson's Disease Clinical Trial

Official title:

Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02768077
• Other study ID #: Circadin-2015-07
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 9, 2016
• Last updated: May 16, 2016
• Start date: January 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2016
• Source: Kuhnil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Parkinson Disease
• Parkinson's Disease
• Sleep Wake Disorders

Intervention

Drug:
• Melatonin(Circadin®)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kuhnil Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Variations in CGI(Clinical Global Impression)		Baseline and immediately after administering the drug for 4 weeks	No
Other	Variations in PGI(Patient Global Impression)		Baseline and immediately after administering the drug for 4 weeks	No
Other	Number of subjects with adverse events		4 weeks of drug treatment	Yes
Other	Number of subjects with serious adverse events		4 weeks of drug treatment	Yes
Primary	Variation in PSQI(Pittsburgh Sleep Quality Index)		Baseline and immediately after administering the drug for 4 weeks	No
Secondary	Variations in UPDRS(Unified Parkinson Disease Rating Scale)		Baseline and immediately after administering the drug for 4 weeks	No
Secondary	Variations in H & Y Scale(Hoehn and Yahr Scale)		Baseline and immediately after administering the drug for 4 weeks	No
Secondary	Variations in NMSS(Non-Motor Symptom assessment Scale)		Baseline and immediately after administering the drug for 4 weeks	No
Secondary	Variations in ESS(The Epworth Sleepiness Scale)		Baseline and immediately after administering the drug for 4 weeks	No
Secondary	Variations in PDSS(The Parkinson's Disease Sleep Scale)		Baseline and immediately after administering the drug for 4 weeks	No
Secondary	Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)		Baseline and immediately after administering the drug for 4 weeks	No
Secondary	Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)		Baseline and immediately after administering the drug for 4 weeks	No