REM Sleep Behavior Disorder Clinical Trial
Official title:
Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism: a Prospective, Randomized, Double-blind and Placebo-controlled Trial
The purpose of this study is to determine whether clonazepam is effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD).
RBD is one of the representative non-motor symptoms of PD and other synucleinopathies.
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 used for treatment of choice of RBD. It decreased RBD symptoms completely in
55-79% and partially in 11-32% of patients. However, these results are based on open-label
or descriptive studies. There has been no randomized placebo controlled study that evaluated
the efficacy and safety of clonazepam for treating RBD.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03671772 -
Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the FDRs of Patients With RBD
|
||
| Recruiting |
NCT05109364 -
Terazosin and Parkinson's Disease Extension Study
|
Phase 2 | |
| Recruiting |
NCT03288909 -
Ultra High Field Magnetic Resonance Imaging as a Biomarker for Premotor Parkinson's Disease
|
||
| Completed |
NCT04006925 -
Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
|
Phase 4 | |
| Completed |
NCT03353207 -
Striatal Dopamine Transmission in Individuals With Isolated Rapid Eye Movement Sleep With Atonia: a Search for Precursor Biomarker for Neurodegeneration
|
||
| Completed |
NCT02824341 -
Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder
|
N/A | |
| Recruiting |
NCT03671798 -
Establish a National Registry of REM Sleep Behavior Disorder
|
||
| Enrolling by invitation |
NCT01453127 -
DaTSCAN Imaging in Aging and Neurodegenerative Disease
|
Phase 4 | |
| Terminated |
NCT02871427 -
Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder
|
Phase 2 | |
| Completed |
NCT03595475 -
Prodromal Markers of First-degree Relatives of Patients With Psychiatric Disorders Comorbid With RBD
|
||
| Recruiting |
NCT03660982 -
Familial Aggregation and Biomarkers in REM Sleep Behaviour Disorder.
|
||
| Completed |
NCT03255642 -
Efficacy and Safety of Melatonin and Clonazepam for IRBD
|
N/A | |
| Recruiting |
NCT05904717 -
Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder
|
Phase 2 | |
| Not yet recruiting |
NCT06140511 -
DREAMER - IsolateD REM Sleep Without Atonia as a Risk Factor for REM Sleep Behavior disordER
|
||
| Recruiting |
NCT04386317 -
Terazosin Effect on Cardiac Changes in Early Parkinson's Disease
|
Phase 2 | |
| Enrolling by invitation |
NCT05514106 -
MIBG in Aging and Neurologic Disorders
|
Phase 4 | |
| Completed |
NCT03645226 -
Gut Microbiota Across Early Stages of Synucleinopathy: From High-risk Relatives, REM Sleep Behavior Disorder to Early Parkinson's Disease
|
||
| Recruiting |
NCT05262543 -
PREdictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study
|
||
| Recruiting |
NCT04071899 -
French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP)
|
||
| Recruiting |
NCT04048603 -
Search for Biomarkers of Neurodegenerative Diseases in Idiopathic REM Sleep Behavior Disorder
|