Parkinson's DiseasePhase 4NCT02768077

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

A Phase 4 study testing Melatonin(Circadin®) in people with Parkinson's Disease, run by Kuhnil Pharmaceutical Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: Melatonin(Circadin®)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: No sites listed yet
Study dates: Jan 2016to Feb 2017
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

About this study

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

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.

Conditions: Parkinson's Disease
Being tested: Melatonin(Circadin®), Placebo
Keywords: melatonin, sleep disturbances
Medical subject headings: Parkinson Disease, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Melatonin(Circadin®)Drug
Also called Prolonged release melatonin 2mg
PlaceboDrug

Study groups in NCT02768077
Study group	Role	What they receive
Melatonin(Circadin®)	Experimental	Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks. Receives: Drug: Melatonin(Circadin®)
Placebo	Placebo comparator	Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Variation in PSQI(Pittsburgh Sleep Quality Index)
Measured: Baseline and immediately after administering the drug for 4 weeks

Secondary outcomes (7)

Variations in UPDRS(Unified Parkinson Disease Rating Scale)
Measured: Baseline and immediately after administering the drug for 4 weeks
Variations in H & Y Scale(Hoehn and Yahr Scale)
Measured: Baseline and immediately after administering the drug for 4 weeks
Variations in NMSS(Non-Motor Symptom assessment Scale)
Measured: Baseline and immediately after administering the drug for 4 weeks
Variations in ESS(The Epworth Sleepiness Scale)
Measured: Baseline and immediately after administering the drug for 4 weeks
Variations in PDSS(The Parkinson's Disease Sleep Scale)
Measured: Baseline and immediately after administering the drug for 4 weeks
Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)
Measured: Baseline and immediately after administering the drug for 4 weeks
Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)
Measured: Baseline and immediately after administering the drug for 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Feb 2017

First posted11 May 2016 (estimated)
Study startJan 2016
Primary completionFeb 2017 (estimated)
Study completionFeb 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02768077
Sponsor's protocol ID: Circadin-2015-07
Status last verified: May 2016
First submitted: 9 May 2016
Last updated: 18 May 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial
ClinicalTrials.gov ID: NCT02768077
Acronym / sponsor ID: Circadin-2015-07
Conditions: Parkinson's Disease
Keywords: melatonin, sleep disturbances
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Kuhnil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Feb 2017 (estimated)
Study completion: Feb 2017 (estimated)
First posted: 11 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Melatonin(Circadin®)	Experimental	Drug: Melatonin(Circadin®)Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.
Placebo	Placebo comparator	Drug: PlaceboPlacebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (7 listed)

Patients with a serious cognitive disorder, behavioral disorder, or mental illness
Patients with a serious medical disease
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Melatonin(Circadin®)Also: Prolonged release melatonin 2mg	Drug	Melatonin(Circadin®)
Placebo	Drug	Placebo

Primary outcome

Variation in PSQI(Pittsburgh Sleep Quality Index)
Time frame: Baseline and immediately after administering the drug for 4 weeks

7 secondary outcomes

Variations in UPDRS(Unified Parkinson Disease Rating Scale)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in H & Y Scale(Hoehn and Yahr Scale)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in NMSS(Non-Motor Symptom assessment Scale)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in ESS(The Epworth Sleepiness Scale)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in PDSS(The Parkinson's Disease Sleep Scale)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)
Time frame: Baseline and immediately after administering the drug for 4 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
Individual participant dataSharing planned: Undecided

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jisun Kim principal investigator

Soon Chun Hyang University Hospital, Department of Neurology

Jin Whan Cho principal investigator

Samsung Medical Center, Department of Neurology

Eungseok Oh principal investigator

Chungnam National University Hospital, Department of Neurology

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Melatonin(Circadin®) in people with Parkinson's Disease, run by Kuhnil Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variation in PSQI(Pittsburgh Sleep Quality Index) (time frame: Baseline and immediately after administering the drug for 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02768077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.