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

Kuhnil Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: Melatonin(Circadin®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02768077

Circadin-2015-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Melatonin(Circadin®)

Experimental group

Description:

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

Treatment:

Drug: Melatonin(Circadin®)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo