Clinical trial NCT02312908: Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism
Official title: Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism: a Prospective, Randomized, Double-blind and Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: REM Sleep Behavior Disorder
Keywords: REM Sleep Behavior Disorder
Parkinson Disease
Placebos
Randomized Controlled Trial
Double-Blind Method
Clinical Trial
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2014-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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 been 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.

Eligibility criteria: Inclusion Criteria:

* Subject was enrolled voluntarily and understood the contents of this clinical trial
* Subject was diagnosed as Parkinson disease (PD) or Parkinson's syndrome
* 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
* 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.)?"

Exclusion Criteria:

* Existence of cognitive decline hard to participate in the clinical trial
* Subject has confusion or visual hallucination in daytime
* Diagnosed as obstructive sleep apnea or severe snoring
* Previous clonazepam treatment within 4 weeks
* Current treatment with benzodiazepines at bedtime
* Alcoholics or drug abuser
* Lactating, pregnant, or possible pregnant
* Hypersensitivity to clonazepam or benzodiazepines
* 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

Primary outcomes:
measure: Clinical Global Impression-Improvement scale (CGI-I)
timeFrame: Four weeks (plus or minus 3 days)
Secondary outcomes:
measure: Clinical Global Impression-Severity scale (CGI-S)
timeFrame: Four weeks (plus or minus 3 days)
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Four weeks (plus or minus 3 days)
measure: Parkinson Disease Sleep Scale (PDSS)
timeFrame: Four weeks (plus or minus 3 days)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Four weeks (plus or minus 3 days)
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Four weeks (plus or minus 3 days)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Beom Seok Jeon, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
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