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REM Sleep Behavior DisorderPhase 2NCT02789592

Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease

A Phase 2 study testing Melatonin PR and Clonazepam in people with REM Sleep Behavior Disorder and Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to determine whether melatonin prolonged-release (PR) and clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD). Read more about this study

Who is it for?
Ages 30 years and older
What is being tested?
Melatonin PR and Clonazepam
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
Jul 2016to Dec 2019
Phase
Phase 2
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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject was enrolled voluntarily and understood the contents of this clinical trial
  • Subject was diagnosed as Parkinson disease (PD)
  • Hoehn and Yahr (H\&Y) stage 1, 2, or 3
  • Existence of caregivers who can provide a information about symptoms of rapid eye movement sleep disorder (RBD) of the participant
  • RBD frequency is one or more per week
  • Existence of RBD by answering "yes" to the question (RBD-1Q): "Have you ever been told, or suspected yourself, that you seem to 'act out your dreams' while asleep (for example, punching, flailing your arms in the air, making running movements, etc.)?"
  • Good compliance for reporting PGI scores and sleep diary

Who cannot join

  • Existence of cognitive decline hard to participate in the clinical trial
  • Hypersensitivity to melatonin or clonazepam
  • Previous melatonin or clonazepam treatment within 1 month
  • Changing anti-parkinsonian medications within 1 month
  • Current treatment with sedatives or hypnotics at bedtime
  • Diagnosed as epilepsy or current treatment with anti-epileptic drugs
Show all 18Show fewer
  • Severe trauma history due to RBD
  • Lactating, pregnant, or possible pregnant
  • Subject has confusion or visual hallucination in daytime
  • Diagnosed as obstructive sleep apnea or severe snoring
  • Diagnosed as other parasomnia
  • Presence of severe psychiatric illness
  • Alcoholics or drug abuser
  • Myasthenia gravis
  • Acute narrow-angle glaucoma
  • Prior participation to other clinical trials within 3 months
  • Presence of severe comorbidities or a cancer
  • Existence of illness or problems which makes difficult to be enrolled to this trial judged by clinicians

Trial locations and contacts

1 site in 1 country.

Beomseok Jeon, MD, PhD contact

brain@snu.ac.kr

Chae Won Shin, MD, MSc contact

chroma0202@gmail.com

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Disorder in Parkinson Disease

The purpose of this study is to determine whether melatonin prolonged-release (PR) and clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD).

Read the detailed description

RBD is one of the representative non-motor symptoms of PD. Patients with RBD show dream-enacting behaviors such as punching, kicking, singing, screaming, or somnambulism. These can interfere in sleep quality and increase the risk of falling down from the bed and physical injuries of both the patient and sleep partner. Therefore, qualities of life of the patient and sleep partner are negatively influenced by presence of RBD.

Clonazepam has been used for treatment of choice of RBD. However, the efficacy of clonazepam is not proven in the clinical trial. Clonazepam has several side effects that could be problematic in PD patients such as increasing fall-down risk, daytime somnolence, and cognitive decline. Melatonin is a second-line treatment option for RBD, but there has been only one randomized crossover trial that evaluated the efficacy of melatonin on RBD. Finally, there has been no study that evaluate and compare the efficacy and safety of melatonin and clonazepam for treatment of RBD.

Being tested
Melatonin PR, Clonazepam, Melatonin PR placebo, Clonazepam placebo
Keywords
REM Sleep Behavior Disorder, Parkinson Disease, Randomized Controlled Trial, Clinical Trial, Melatonin, Clonazepam
Medical subject headings
REM Sleep Behavior Disorder, Parkinson Disease

What participants receive

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

  • Melatonin PRDrug

    Also called Circadin

    For experimental treatment of RBD

  • ClonazepamDrug

    Also called Rivotril

    For experimental treatment of RBD

  • Melatonin PR placeboDrug

    Also called Placebo tablet of Melatonin PR

    Placebo pill manufactured to mask melatonin PR 2mg tablet

  • Clonazepam placeboDrug

    Also called Placebo tablet of clonazepam

    Placebo pill manufactured to mask clonazepam 0.5mg tablet

Study groups in NCT02789592
Study groupRoleWhat they receive
Group 1ExperimentalPhase 1: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks
Receives: Drug: Melatonin PR; Drug: Clonazepam; Drug: Melatonin PR placebo; Drug: Clonazepam placebo
Group 2ExperimentalPhase 1: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks
Receives: Drug: Melatonin PR; Drug: Clonazepam; Drug: Melatonin PR placebo; Drug: Clonazepam placebo
Group 3ExperimentalPhase 1: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks
Receives: Drug: Melatonin PR; Drug: Clonazepam; Drug: Melatonin PR placebo; Drug: Clonazepam placebo
Group 4ExperimentalPhase 1: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks
Receives: Drug: Melatonin PR; Drug: Clonazepam; Drug: Melatonin PR placebo; Drug: Clonazepam placebo
Group 5ExperimentalPhase 1: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks
Receives: Drug: Melatonin PR; Drug: Clonazepam; Drug: Melatonin PR placebo; Drug: Clonazepam placebo
Group 6ExperimentalPhase 1: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks
Receives: Drug: Melatonin PR; Drug: Clonazepam; Drug: Melatonin PR placebo; Drug: Clonazepam placebo

What is being measured

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

  1. Clinical Global Impression-Improvement scale (CGI-I)

    Clinician assessed rating scale of clinical improvement or worsening relative to a baseline state, scored as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

    Measured: Four weeks (plus or minus 3 days)

Secondary outcomes (9)

  1. Mean change of the Clinical Global Impression-Severity scale (CGI-S)

    Measured: Four weeks (plus or minus 3 days)

  2. Patient Global Impression-Improvement scale (PGI-I)

    Measured: Four weeks (plus or minus 3 days)

  3. Mean change of the Patient Global Impression-Severity scale (PGI-S)

    Measured: Four weeks (plus or minus 3 days)

  4. modified RBD Questionnaire-HongKong (mRBDQ-HK)

    Measured: Four weeks (plus or minus 3 days)

  5. Mean change of the Epworth Sleepiness Scale (ESS)

    Measured: Four weeks (plus or minus 3 days)

  6. Mean change of the Parkinson Disease Sleep Scale (PDSS)

    Measured: Four weeks (plus or minus 3 days)

  7. Mean change of the Montreal Cognitive Assessment (MoCA)

    Measured: Four weeks (plus or minus 3 days)

  8. Mean change of the Unified Parkinson's Disease Rating Scale (UPDRS)

    Measured: Four weeks (plus or minus 3 days)

  9. Sleep diary

    Measured: Four weeks (plus or minus 3 days)

Timeline

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

  1. First posted3 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02789592
Sponsor's protocol ID
H-1604-134-757
Status last verified
Jun 2016
First submitted
31 May 2016
Last updated
3 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Arnulf I. REM sleep behavior disorder: motor manifestations and pathophysiology. Mov Disord. 2012 May;27(6):677-89. doi: 10.1002/mds.24957. Epub 2012 Mar 22.

    PubMed 22447623

  • Sixel-Doring F, Trautmann E, Mollenhauer B, Trenkwalder C. Associated factors for REM sleep behavior disorder in Parkinson disease. Neurology. 2011 Sep 13;77(11):1048-54. doi: 10.1212/WNL.0b013e31822e560e. Epub 2011 Aug 10.

    PubMed 21832215

  • Kunz 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

  • Schenck CH, Montplaisir JY, Frauscher B, Hogl B, Gagnon JF, Postuma R, Sonka K, Jennum P, Partinen M, Arnulf I, Cochen de Cock V, Dauvilliers Y, Luppi PH, Heidbreder A, Mayer G, Sixel-Doring F, Trenkwalder C, Unger M, Young P, Wing YK, Ferini-Strambi L, Ferri R, Plazzi G, Zucconi M, Inoue Y, Iranzo A, Santamaria J, Bassetti C, Moller JC, Boeve BF, Lai YY, Pavlova M, Saper C, Schmidt P, Siegel JM, Singer C, St Louis E, Videnovic A, Oertel W. Rapid eye movement sleep behavior disorder: devising controlled active treatment studies for symptomatic and neuroprotective therapy--a consensus statement from the International Rapid Eye Movement Sleep Behavior Disorder Study Group. Sleep Med. 2013 Aug;14(8):795-806. doi: 10.1016/j.sleep.2013.02.016. Epub 2013 Jul 22.

    PubMed 23886593

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melatonin PR and Clonazepam in people with REM Sleep Behavior Disorder and Parkinson Disease, 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 7 inclusion and 18 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 3 Jun 2016. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Beomseok Jeon, MD, PhD (brain@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Global Impression-Improvement scale (CGI-I) (time frame: Four weeks (plus or minus 3 days)). 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 NCT02789592, 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 3 Jun 2016.

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