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

NCT02768077 | Unknown Phase 4

• 1 other identifier: Circadin-2015-07
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Keywords

melatonin; sleep disturbances

Outcome Measures

Primary Outcomes (1)

• Variation in PSQI(Pittsburgh Sleep Quality Index)

  Baseline and immediately after administering the drug for 4 weeks

Secondary Outcomes (7)

• 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 ESS(The Epworth Sleepiness Scale)

  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

Other Outcomes (4)

• 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

Study Arms (2)

Melatonin(Circadin®)

EXPERIMENTAL

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

Drug: Melatonin(Circadin®)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Melatonin(Circadin®) DRUG

Also known as: Prolonged release melatonin 2mg

Melatonin(Circadin®)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet the clinical criteria for idiopathic Parkinson's disease (United Kingdom Parkinson's Disease Brain Bank Criteria)
• Patients who complain of sleep disturbances such as insomnia, REM sleep behavior disorder, excessive daytime sleepiness (EDS), etc.
• Patients who have received drug treatment for at least 6 months since their diagnosis
• Male or female patient aged 55 or older
• 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)

You may not qualify if:

• Patients with a serious cognitive disorder, behavioral disorder, or mental illness
• 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
• 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
• Patients who have a history of hypersensitivity to the investigational drug or a drug similar in component or who have had heavy metal poisoning
• Patients who are taking drugs which could effect on sleep such as rivotril, quetiapine, lexapro, etc.

Sponsors & Collaborators

• Kuhnil Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Parkinson Disease; Parasomnias

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Wake Disorders; Mental Disorders

Study Officials

• Jisun Kim

  Soon Chun Hyang University Hospital, Department of Neurology

  PRINCIPAL INVESTIGATOR

• Jin Whan Cho

  Samsung Medical Center, Department of Neurology

  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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 11, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 18, 2016

Record last verified: 2016-05