Panacea Index Logo

Command Palette

Search for a command to run...

Clinical trials in REM sleep behavioural disorder: challenges and opportunities.

Journal of neurology, neurosurgery, and psychiatry
July 1, 2020
Aleksandar Videnovic et al. (11 authors)
Journal ArticleResearch Support, N.I.H., ExtramuralReviewHuman Study
Study Details

Study Goal

The researchers aimed to evaluate the role of melatonin as a symptomatic treatment for rapid eye movement sleep behavioural disorder (RBD) and its potential in clinical trials for synucleinopathies.

Results Summary

The abstract notes that melatonin is commonly used as a symptomatic treatment for RBD, but it does not provide specific efficacy data. The study emphasizes the need for clinical trials to establish evidence-based treatments for RBD.

Population

Individuals with rapid eye movement sleep behavioural disorder (RBD), considered an early prodromal stage of synucleinopathy.

Effective Dosage

Not specified

Duration

Not specified

Interactions

None mentioned

Extracted Claims (4)
InterventionDirectionEndpointPopulationDosageImpactClaim #
clonazepam
no change
rapid eye movement sleep behavioural disorder (RBD)
RBD population
-
most commonly used as symptomatic treatments
#1
melatonin
no change
rapid eye movement sleep behavioural disorder (RBD)
RBD population
-
most commonly used as symptomatic treatments
#2
disease-modifying treatments
neutral
phenoconversion to an overt synucleinopathy
RBD population
-
recommended primary outcome is phenoconversion
#3
symptomatic treatments
neutral
RBD-related movements and vocalisations
RBD population
-
objective polysomnogram-based measurement should be the primary outcome measure
#4
Abstract

The rapid eye movement sleep behavioural disorder (RBD) population is an ideal study population for testing disease-modifying treatments for synucleinopathies, since RBD represents an early prodromal stage of synucleinopathy when neuropathology may be more responsive to treatment. While clonazepam and melatonin are most commonly used as symptomatic treatments for RBD, clinical trials of symptomatic treatments are also needed to identify evidence-based treatments. A comprehensive framework for both disease-modifying and symptomatic treatment trials in RBD is described, including potential treatments in the pipeline, cost-effective participant recruitment and selection, study design, outcomes and dissemination of results. For disease-modifying treatment clinical trials, the recommended primary outcome is phenoconversion to an overt synucleinopathy, and stratification features should be used to select a study population at high risk of phenoconversion, to enable more rapid clinical trials. For symptomatic treatment clinical trials, objective polysomnogram-based measurement of RBD-related movements and vocalisations should be the primary outcome measure, rather than subjective scales or diaries. Mobile technology to enable objective measurement of RBD episodes in the ambulatory setting, and advances in imaging, biofluid, tissue, and neurophysiological biomarkers of synucleinopathies, will enable more efficient clinical trials but are still in development. Increasing awareness of RBD among the general public and medical community coupled with timely diagnosis of these diseases will facilitate progress in the development of therapeutics for RBD and associated neurodegenerative disorders.

Medical Subject Headings (MeSH)
Clinical Trials as TopicHumansREM Sleep Behavior DisorderResearch DesignSleep, REM
Study Links
Quality Scores
SafetyNot Assessed
Efficacy70/10
Quality80/10
Citation Metrics
Total Citations60
Citations/Year12.0
Relative Citation Ratio4.78
NIH Percentile92.5%
Research Impact Scores
APT Score0.95
Weight Score2.63
Normalized Score0.64
Related Supplements
Clinical trials in REM sleep behavioural disorder: challenge... | Panacea Index