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Status unknownNCT03258294Updated Aug 23, 2017

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

A Phase 4 interventional study of Melatonin(Circadin®) and Placebo Oral Tablet in Parkinson's Disease, sponsored by KIMJisun. Status unknown. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2017-08-23.

Sponsored by KIMJisun · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
55 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Parkinson's Disease

Keywords

  • melatonin
  • sleep disturbances
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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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 investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding
  4. Patients who have a history of hypersensitivity to the investigational products or a drug similar in component or who have had heavy metal poisoning
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
82 participants (estimated)

Study arms

  • Experimental
    Melatonin(Circadin®)

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

    Drug: Melatonin(Circadin®)

  • Placebo comparator
    Placebo

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

    Drug: Placebo Oral Tablet

Interventions

  • DrugMelatonin(Circadin®)
  • DrugPlacebo Oral Tablet
05

What researchers measure

Primary outcomes

  1. Variation in PSQI(Pittsburgh Sleep Quality Index)

    Variation in PSQI before and immediately after the administration of the drug

    Time frame: Baseline and immediately after administering the drug for 4 weeks

Secondary outcomes

  1. Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)

    Time frame: Baseline and immediately after administering the drug for 4 weeks

  2. Variations in PDSS(The Parkinson's Disease Sleep Scale)

    Time frame: Baseline and immediately after administering the drug for 4 weeks

  3. Variations in ESS(The Epworth Sleepiness Scale)

    Time frame: Baseline and immediately after administering the drug for 4 weeks

  4. Variations in UPDRS(Unified Parkinson Disease Rating Scale)

    Time frame: Baseline and immediately after administering the drug for 4 weeks

  5. Variations in H & Y Scale(Hoehn and Yahr Scale)

    Time frame: Baseline and immediately after administering the drug for 4 weeks

  6. Variations in NMSS(Non-Motor Symptom assessment Scale)

    Time frame: Baseline and immediately after administering the drug for 4 weeks

  7. Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)

    Time frame: Baseline and immediately after administering the drug for 4 weeks

Other outcomes

  1. Variations in CGI(Clinical Global Impression)

    Time frame: Baseline and immediately after administering the drug for 4 weeks

  2. Variations in PGI(Patient Global Impression)

    Time frame: Baseline and immediately after administering the drug for 4 weeks

  3. Number of subjects with adverse events

    Time frame: 4 weeks of drug treatment

  4. Number of subjects with serious adverse events

    Time frame: 4 weeks of drug treatment

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Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03258294
Lead sponsor
KIMJisun
Collaborators
Kuhnil Pharmaceutical Co., Ltd.
Responsible party
KIMJisun (Instructor, Samsung Medical Center) — Sponsor-investigator
First posted
Aug 23, 2017
Start date
Jan 13, 2016
Primary completion
Dec 30, 2018 (estimated)
Completion
Dec 30, 2018 (estimated)
Last update
Aug 23, 2017

Study contacts

Jisun Kim
principal investigator · Samsung Medical Center, Department of Neurology
Eungseok Oh
principal investigator · Chungnam National University Hospital, Department of Neurology
Wooyoung Jang
principal investigator · Gangneung Asan Hospital, Department of Neurology
Jinse Park
principal investigator · Inje University Haeundae Paik Hospital, Department of Neurology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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