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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Seoul National University Hospital

Current Primary Outcome: Clinical Global Impression-Improvement scale (CGI-I) [ Time Frame: Four weeks (plus or minus 3 days) ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Global Impression-Severity scale (CGI-S) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Parkinson Disease Sleep Scale (PDSS) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: Four weeks (plus or minus 3 days) ]


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: December 5, 2014
Date Started: March 2015
Date Completion:
Last Updated: April 21, 2016
Last Verified: April 2016