Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism

Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism: a Prospective, Randomized, Double-blind and Placebo-controlled Trial

Sponsors

Lead Sponsor: Seoul National University Hospital

Collaborator: Ministry of Food and Drug Safety, Korea

Source Seoul National University Hospital
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.

Overall Status Completed
Start Date March 2015
Completion Date March 2016
Primary Completion Date March 2016
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Clinical Global Impression-Improvement scale (CGI-I) Four weeks (plus or minus 3 days)
Secondary Outcome
Measure Time Frame
Clinical Global Impression-Severity scale (CGI-S) Four weeks (plus or minus 3 days)
Epworth Sleepiness Scale (ESS) Four weeks (plus or minus 3 days)
Parkinson Disease Sleep Scale (PDSS) Four weeks (plus or minus 3 days)
Montreal Cognitive Assessment (MoCA) Four weeks (plus or minus 3 days)
Unified Parkinson's Disease Rating Scale (UPDRS) Four weeks (plus or minus 3 days)
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: Clonazepam

Description: For experimental treatment of RBD

Arm Group Label: Clonazepam

Other Name: Rivotril

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo pill manufactured to mask clonazepam 0.5mg tablet

Arm Group Label: Placebo

Other Name: Placebo tablet of Rivotril

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

Gender: All

Minimum Age: 30 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Beom Seok Jeon, MD, Ph.D Principal Investigator Seoul National University Hospital
Location
Facility: Seoul National University Hospital
Location Countries

Korea, Republic of

Verification Date

April 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seoul National University Hospital

Investigator Full Name: BS Jeon

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Clonazepam

Type: Experimental

Description: Clonazepam 0.5 mg 1 Tablet by mouth, 1/day before sleeping for 4 weeks

Label: Placebo

Type: Placebo Comparator

Description: Placebo 1 Tablet by mouth, 1/day before sleeping for 4 weeks

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov