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

NCT ID: NCT02768077

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-02-28

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Melatonin(Circadin®)

Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.

Group Type: EXPERIMENTAL

Melatonin(Circadin®)

Intervention Type: DRUG

Placebo

Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Melatonin(Circadin®)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Prolonged release melatonin 2mg

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuhnil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jisun Kim

Role: PRINCIPAL_INVESTIGATOR

Soon Chun Hyang University Hospital, Department of Neurology

Jin Whan Cho

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Department of Neurology

Eungseok Oh

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital, Department of Neurology

Wooyoung Jang

Role: PRINCIPAL_INVESTIGATOR

Gangneung Asan Hospital, Department of Neurology

Jinse Park

Role: PRINCIPAL_INVESTIGATOR

Inje University Haeundae Paik Hospital, Department of Neurology

Other Identifiers

Circadin-2015-07

Identifier Type: -

Identifier Source: org_study_id