Clinical Trial: Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Diso

Brief Summary: The purpose of this study is to determine whether melatonin prolonged-release (PR) and clonazepam are 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. 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. However, the efficacy of clonazepam is not proven in the clinical trial. Clonazepam has several side effects that could be problematic in PD patients such as increasing fall-down risk, daytime somnolence, and cognitive decline. Melatonin is a second-line treatment option for RBD, but there has been only one randomized crossover trial that evaluated the efficacy of melatonin on RBD. Finally, there has been no study that evaluate and compare the efficacy and safety of melatonin and clonazepam for treatment of 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:

  • Mean change of the Clinical Global Impression-Severity scale (CGI-S) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Patient Global Impression-Improvement scale (PGI-I) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Mean change of the Patient Global Impression-Severity scale (PGI-S) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • modified RBD Questionnaire-HongKong (mRBDQ-HK) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Mean change of the Epworth Sleepiness Scale (ESS) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Mean change of the Parkinson Disease Sleep Scale (PDSS) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Mean change of the Montreal Cognitive Assessment (MoCA) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Mean change of the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: Four weeks (plus or minus 3 days) ]
  • Sleep diary [ Time Frame: Four weeks (plus or minus 3 days) ]


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: May 31, 2016
Date Started: July 2016
Date Completion: December 2019
Last Updated: June 2, 2016
Last Verified: June 2016