REM Sleep Behavior DisorderNCT03255642
Efficacy and Safety of Melatonin and Clonazepam for IRBD
A study testing Melatonin 2mg and ClonazePAM 0.5 MG in people with REM Sleep Behavior Disorder, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
Trial summary
This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- REM Sleep Behavior Disorder
- What is being tested?
- Melatonin 2mg and ClonazePAM 0.5 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Nov 2017to 1 Dec 2020
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- REM sleep behavior disorder (ICSD-3 criteria)
Who cannot join
- Neurological disorder including epilepsy or stroke
- History of psychiatric illness
- Neurodegenerative disease including dementia or parkinsonism.
- Medication affecting sleep within 1 month
- Intake of melatonin or clonazepam within 1 week.
- Unable to complete questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.
This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.
Read the detailed description
This study is open-label parallel trial with 4 weeks treatment with slow-release melatonin (Circadin) or with clonazepam (Rivotril).
Polysomnography, symptom diary and questionnaire (Clinical Global Impression, RBDQ-HK, PSQI, ESS, SSS, ISI, BDI-II) will be performed before and after 4 weeks of each medications.
- Conditions
- REM Sleep Behavior Disorder
- Being tested
- Melatonin 2mg, ClonazePAM 0.5 MG
- Keywords
- Clonazepam, Melatonin, Treatment, REM Sleep Behavior Disorder
- 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.
Melatonin 2mgDrug
Also called Circadin
4 weeks of 2mg prolonged release melatonin (Circadin)
ClonazePAM 0.5 MGDrug
Also called Rivotril
4 weeks of 0.5mg clonazepam (Rivotril)
| Study group | Role | What they receive |
|---|---|---|
| Melatonin 2mg | Active comparator | 4 weeks of 2mg of prolonged release Melatonin Receives: Drug: Melatonin 2mg |
| ClonazePAM 0.5 MG | Placebo comparator | 4 weeks of 0.5mg of rivotril Receives: Drug: ClonazePAM 0.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Automated REM without atonia index
Percentage seconds with chin EMG amplitude<1uV/ Total REM seconds.
Measured: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Secondary outcomes (4)
Clinical Global Impression of RBD symptom severity
Clinical Global Impression scale score provided by patient and caregiver.
Measured: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
REM sleep behavior disorder symptom severity
REM sleep behavior disorder questionnaire-Hong Kong total score
Measured: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Sleep quality
Pittsburg Sleep Quality Index total score
Measured: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Depression
Beck depression inventory-II total score
Measured: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start9 Nov 2017
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for REM Sleep Behavior DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Open-label study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital at Gangdong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Chul Shin, Kyung Hee University Hospital at Gangdong
- Investigators
- Won Chul Shin, M.D. Ph.D., Principal investigator, KyungHee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255642
- Sponsor's protocol ID
- 2017-03-011
- Status last verified
- Feb 2021
- First submitted
- 29 May 2017
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferri R, Marelli S, Ferini-Strambi L, Oldani A, Colli F, Schenck CH, Zucconi M. An observational clinical and video-polysomnographic study of the effects of clonazepam in REM sleep behavior disorder. Sleep Med. 2013 Jan;14(1):24-9. doi: 10.1016/j.sleep.2012.09.009. Epub 2012 Oct 23.
PubMed 23098778Kunz 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 20561180McCarter SJ, Boswell CL, St Louis EK, Dueffert LG, Slocumb N, Boeve BF, Silber MH, Olson EJ, Tippmann-Peikert M. Treatment outcomes in REM sleep behavior disorder. Sleep Med. 2013 Mar;14(3):237-42. doi: 10.1016/j.sleep.2012.09.018. Epub 2013 Jan 23.
PubMed 23352028McGrane IR, Leung JG, St Louis EK, Boeve BF. Melatonin therapy for REM sleep behavior disorder: a critical review of evidence. Sleep Med. 2015 Jan;16(1):19-26. doi: 10.1016/j.sleep.2014.09.011. Epub 2014 Oct 13.
PubMed 25454845Nardone R, Golaszewski S, Holler Y, Christova M, Trinka E, Brigo F. Neurophysiological insights into the pathophysiology of REM sleep behavior disorders: a review. Neurosci Res. 2013 Jul;76(3):106-12. doi: 10.1016/j.neures.2013.03.009. Epub 2013 Mar 28.
PubMed 23542221Iranzo A, Molinuevo JL, Santamaria J, Serradell M, Marti MJ, Valldeoriola F, Tolosa E. Rapid-eye-movement sleep behaviour disorder as an early marker for a neurodegenerative disorder: a descriptive study. Lancet Neurol. 2006 Jul;5(7):572-7. doi: 10.1016/S1474-4422(06)70476-8.
PubMed 16781987Byun JI, Shin YY, Seong YA, Yoon SM, Hwang KJ, Jung YJ, Cha KS, Jung KY, Shin WC. Comparative efficacy of prolonged-release melatonin versus clonazepam for isolated rapid eye movement sleep behavior disorder. Sleep Breath. 2023 Mar;27(1):309-318. doi: 10.1007/s11325-022-02572-8. Epub 2022 Feb 9.
PubMed 35141811
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT03255642
- Acronym / sponsor ID
- 2017-03-011
- Conditions
- REM Sleep Behavior Disorder
- Keywords
- Clonazepam, Melatonin, Treatment, REM Sleep Behavior Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kyung Hee University Hospital at GangdongUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 21 Aug 2017 (actual)
- 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.
This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.
Detailed description
This study is open-label parallel trial with 4 weeks treatment with slow-release melatonin (Circadin) or with clonazepam (Rivotril).
Polysomnography, symptom diary and questionnaire (Clinical Global Impression, RBDQ-HK, PSQI, ESS, SSS, ISI, BDI-II) will be performed before and after 4 weeks of each medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized Open-label study
| Arm | Type | Receives |
|---|---|---|
| Melatonin 2mg | Active comparator | Drug: Melatonin 2mg4 weeks of 2mg of prolonged release Melatonin |
| ClonazePAM 0.5 MG | Placebo comparator | Drug: ClonazePAM 0.5 MG4 weeks of 0.5mg of rivotril |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- REM sleep behavior disorder (ICSD-3 criteria)
Key exclusion criteria (6 listed)
- Neurological disorder including epilepsy or stroke
- History of psychiatric illness
- Neurodegenerative disease including dementia or parkinsonism.
- Medication affecting sleep within 1 month
- Intake of melatonin or clonazepam within 1 week.
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 2mgAlso: Circadin4 weeks of 2mg prolonged release melatonin (Circadin) | Drug | Melatonin 2mg |
| ClonazePAM 0.5 MGAlso: Rivotril4 weeks of 0.5mg clonazepam (Rivotril) | Drug | ClonazePAM 0.5 MG |
Primary outcome
Automated REM without atonia index
Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Percentage seconds with chin EMG amplitude<1uV/ Total REM seconds.
4 secondary outcomes
Clinical Global Impression of RBD symptom severity
Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
REM sleep behavior disorder symptom severity
Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Sleep quality
Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Depression
Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 23098778Ferri R, Marelli S, Ferini-Strambi L, Oldani A, Colli F, Schenck CH, Zucconi M. An observational clinical and video-polysomnographic study of the effects of clonazepam in REM sleep behavior disorder. Sleep Med. 2013 Jan;14(1):24-9. doi: 10.1016/j.sleep.2012.09.009. Epub 2012 Oct 23.
- 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.
- Background: PubMed 23352028McCarter SJ, Boswell CL, St Louis EK, Dueffert LG, Slocumb N, Boeve BF, Silber MH, Olson EJ, Tippmann-Peikert M. Treatment outcomes in REM sleep behavior disorder. Sleep Med. 2013 Mar;14(3):237-42. doi: 10.1016/j.sleep.2012.09.018. Epub 2013 Jan 23.
- Background: PubMed 25454845McGrane IR, Leung JG, St Louis EK, Boeve BF. Melatonin therapy for REM sleep behavior disorder: a critical review of evidence. Sleep Med. 2015 Jan;16(1):19-26. doi: 10.1016/j.sleep.2014.09.011. Epub 2014 Oct 13.
- Background: PubMed 23542221Nardone R, Golaszewski S, Holler Y, Christova M, Trinka E, Brigo F. Neurophysiological insights into the pathophysiology of REM sleep behavior disorders: a review. Neurosci Res. 2013 Jul;76(3):106-12. doi: 10.1016/j.neures.2013.03.009. Epub 2013 Mar 28.
- Background: PubMed 16781987Iranzo A, Molinuevo JL, Santamaria J, Serradell M, Marti MJ, Valldeoriola F, Tolosa E. Rapid-eye-movement sleep behaviour disorder as an early marker for a neurodegenerative disorder: a descriptive study. Lancet Neurol. 2006 Jul;5(7):572-7. doi: 10.1016/S1474-4422(06)70476-8.
- Derived from this study: PubMed 35141811Byun JI, Shin YY, Seong YA, Yoon SM, Hwang KJ, Jung YJ, Cha KS, Jung KY, Shin WC. Comparative efficacy of prolonged-release melatonin versus clonazepam for isolated rapid eye movement sleep behavior disorder. Sleep Breath. 2023 Mar;27(1):309-318. doi: 10.1007/s11325-022-02572-8. Epub 2022 Feb 9.
- Individual participant dataSharing planned: Undecided
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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.
Won Chul Shin, M.D. Ph.D. principal investigator
KyungHee University Hospital at Gangdong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 2mg and ClonazePAM 0.5 MG in people with REM Sleep Behavior Disorder, run by Kyung Hee University Hospital at Gangdong 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 21 Feb 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Automated REM without atonia index (time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg). 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 NCT03255642, which also lists 7 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 21 Feb 2021.