REM Sleep Behavior DisorderPhase 4NCT02836743
Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study
A Phase 4 study testing Circadin in people with REM Sleep Behavior Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- REM Sleep Behavior Disorder
- What is being tested?
- Circadin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- REM sleep behavior disorder according to ICSD-3 criteria
- No cognitive deficit or symptom of Parkinsonism
- Those with written consent.
Who cannot join
- who took medication (ex. clonazepam) for REM sleep behavior disorder
- with degenerative neurologic disorder (ex. Parkinson's disease, Multiple System Atrophy, Lewy-body dementia, etc.)
- who took medication that can affect REM sleep behavior disorder (anti-depressant: SSRI, TCA, MAO-inhibitor)
- who is unable to answer questionnaires
- who have hypersensitive reaction to medications
- Pregnant women or breastfeeding
- who are diagnosed with other parasomnia disorder
- with severe medical disorder (severe liver failure, respiratory failure, heart failure, malignant tumor, etc.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Ki-Young Jung, professor, +82-2-2072-0694, jungky10@gmail.com
About this study
Official title: Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study
To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.
Read the detailed description
Investigators planned to administer low (2mg) and high (6mg) dose slow-release melatonin and the placebo for 4 weeks and evaluate Clinical Global Impression scale, RBD questionnaire, PSQI, Epworth sleepiness scale, and quality of life questionnaire (SF-36v2) before and after the treatment along with possible side effects and drug compliance.
- Conditions
- REM Sleep Behavior Disorder
- Being tested
- Circadin, Placebo
- Keywords
- REM sleep behavior disorder, Melatonin
- Medical subject headings
- REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircadinDrug
Also called slow-release melatonin
Slow-release melatonin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Circadin 2mg | Experimental | low-dose (2mg) slow-release melatonin for 1 month. Receives: Drug: Circadin |
| Circadin 6mg | Experimental | high-dose (6mg) slow-release melatonin for 1 month. Receives: Drug: Circadin |
| Placebo | Placebo comparator | Administer placebo pills with identical morphology Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Clinical Global Impression scale
Measured: baseline and 4 weeks
Changes in RBDQ-HK score (RBD questionnaire-HK)
Measured: Baseline and 4 weeks
Secondary outcomes (5)
Sleep quality questionnaire
PSQI
Measured: after taking the treatment for 4 weeks
Sleepiness questionnaire
Epworth sleepiness scale
Measured: after taking the treatment for 4 weeks
Quality of life questionnaire
SF-36 version 2.
Measured: after taking the treatment for 4 weeks
Changes in Dream enactment behavior frequency described in sleep diary
Measured: Baseline and 4 weeks
Drug adverse effect
adverse events and reason for drug withdrawal
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJan 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki-Young Jung, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836743
- Sponsor's protocol ID
- 1505-084-673
- Status last verified
- Apr 2017
- First submitted
- 13 Jul 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Takeuchi N, Uchimura N, Hashizume Y, Mukai M, Etoh Y, Yamamoto K, Kotorii T, Ohshima H, Ohshima M, Maeda H. Melatonin therapy for REM sleep behavior disorder. Psychiatry Clin Neurosci. 2001 Jun;55(3):267-9. doi: 10.1046/j.1440-1819.2001.00854.x.
PubMed 11422870Kunz D, Bes F. Melatonin as a therapy in REM sleep behavior disorder patients: an open-labeled pilot study on the possible influence of melatonin on REM-sleep regulation. Mov Disord. 1999 May;14(3):507-11. doi: 10.1002/1531-8257(199905)14:33.0.co;2-8.
PubMed 10348479Boeve BF, Silber MH, Ferman TJ. Melatonin for treatment of REM sleep behavior disorder in neurologic disorders: results in 14 patients. Sleep Med. 2003 Jul;4(4):281-4. doi: 10.1016/s1389-9457(03)00072-8.
PubMed 14592300Kunz D, Mahlberg R. A two-part, double-blind, placebo-controlled trial of exogenous melatonin in REM sleep behaviour disorder. J Sleep Res. 2010 Dec;19(4):591-6. doi: 10.1111/j.1365-2869.2010.00848.x.
PubMed 20561180
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study
- ClinicalTrials.gov ID
- NCT02836743
- Acronym / sponsor ID
- 1505-084-673
- Conditions
- REM Sleep Behavior Disorder
- Keywords
- REM sleep behavior disorder, Melatonin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 19 Jul 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.
To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.
Detailed description
Investigators planned to administer low (2mg) and high (6mg) dose slow-release melatonin and the placebo for 4 weeks and evaluate Clinical Global Impression scale, RBD questionnaire, PSQI, Epworth sleepiness scale, and quality of life questionnaire (SF-36v2) before and after the treatment along with possible side effects and drug compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Circadin 2mg | Experimental | Drug: Circadinlow-dose (2mg) slow-release melatonin for 1 month. |
| Circadin 6mg | Experimental | Drug: Circadinhigh-dose (6mg) slow-release melatonin for 1 month. |
| Placebo | Placebo comparator | Drug: PlaceboAdminister placebo pills with identical morphology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- REM sleep behavior disorder according to ICSD-3 criteria
- No cognitive deficit or symptom of Parkinsonism
- Those with written consent.
Key exclusion criteria (8 listed)
- who took medication (ex. clonazepam) for REM sleep behavior disorder
- with degenerative neurologic disorder (ex. Parkinson's disease, Multiple System Atrophy, Lewy-body dementia, etc.)
- who took medication that can affect REM sleep behavior disorder (anti-depressant: SSRI, TCA, MAO-inhibitor)
- who is unable to answer questionnaires
- who have hypersensitive reaction to medications
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 |
|---|---|---|
| CircadinAlso: slow-release melatoninSlow-release melatonin | Drug | Circadin 2mg, Circadin 6mg |
| Placebo | Drug | Placebo |
Primary outcome
Changes in Clinical Global Impression scale
Time frame: baseline and 4 weeks
Changes in RBDQ-HK score (RBD questionnaire-HK)
Time frame: Baseline and 4 weeks
5 secondary outcomes
Sleep quality questionnaire
Time frame: after taking the treatment for 4 weeks
Sleepiness questionnaire
Time frame: after taking the treatment for 4 weeks
Quality of life questionnaire
Time frame: after taking the treatment for 4 weeks
Changes in Dream enactment behavior frequency described in sleep diary
Time frame: Baseline and 4 weeks
Drug adverse effect
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Background: PubMed 11422870Takeuchi N, Uchimura N, Hashizume Y, Mukai M, Etoh Y, Yamamoto K, Kotorii T, Ohshima H, Ohshima M, Maeda H. Melatonin therapy for REM sleep behavior disorder. Psychiatry Clin Neurosci. 2001 Jun;55(3):267-9. doi: 10.1046/j.1440-1819.2001.00854.x.
- Background: PubMed 10348479Kunz D, Bes F. Melatonin as a therapy in REM sleep behavior disorder patients: an open-labeled pilot study on the possible influence of melatonin on REM-sleep regulation. Mov Disord. 1999 May;14(3):507-11. doi: 10.1002/1531-8257(199905)14:33.0.co;2-8.
- Background: PubMed 14592300Boeve BF, Silber MH, Ferman TJ. Melatonin for treatment of REM sleep behavior disorder in neurologic disorders: results in 14 patients. Sleep Med. 2003 Jul;4(4):281-4. doi: 10.1016/s1389-9457(03)00072-8.
- Background: PubMed 20561180Kunz D, Mahlberg R. A two-part, double-blind, placebo-controlled trial of exogenous melatonin in REM sleep behaviour disorder. J Sleep Res. 2010 Dec;19(4):591-6. doi: 10.1111/j.1365-2869.2010.00848.x.
- Individual participant dataSharing planned: Undecided
Related trials for REM Sleep Behavior Disorder
RecruitingPhase 2
An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)
REM Sleep Behavior Disorder
Recruiting
Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease
REM Sleep Behavior Disorder, Parkinson s Disease
Active, not recruitingObservational study
Quantification of Phosphorylated Alpha-synuclein in Cutaneous Biopsies as a Prospective Biomarker in Parkinson's Disease
REM Behavior Disorder, Parkinson Disease
Not yet recruitingObservational study
Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study
Parkinson Disease (PD), REM Sleep Behavior Disorder (iRBD)
RecruitingObservational study
Neuroplasticity in RBD
REM Sleep Behavior Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Circadin in people with REM Sleep Behavior Disorder, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 8 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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Ki-Young Jung, M.D. Ph.D. (+82-2-2072-4988, jungky10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Clinical Global Impression scale (time frame: baseline and 4 weeks). The study lists 2 primary outcomes in all. 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 NCT02836743, which also lists 4 linked publications.
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 28 Apr 2017.