Chaewon Shin1, Hyeyoung Park2, Woong-Woo Lee3, Hyun-Jeong Kim4, Han-Joon Kim5, Beomseok Jeon4. 1. Department of Neurology, Kyung Hee University Hospital, Seoul, Republic of Korea. 2. Department of Neurology, Seoul Central Clinic, Seoul, Republic of Korea. 3. Department of Neurology, Eulji General Hospital, 68 Hangeulbiseong-ro, Nowon-gu, Seoul, Republic of Korea. 4. Department of Neurology, MRC and Movement Disorder Center, Seoul National University Hospital, Parkinson Study Group, Seoul National University College of Medicine, Seoul, Republic of Korea. 5. Department of Neurology, MRC and Movement Disorder Center, Seoul National University Hospital, Parkinson Study Group, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: movement@snu.ac.kr.
Abstract
BACKGROUND:Clonazepam is considered to be a first-line treatment for rapid eye movement sleep-related behavior disorder (RBD) in Parkinson's disease (PD). The purpose of this study was to determine the short-term efficacy and safety of clonazepam for the treatment of probable RBD (pRBD) in patients with PD. METHODS: We conducted a four-week, randomized, double-blind, placebo-controlled trial of clonazepam (0.5 mg/day at bedtime) compared to a placebo for RBD symptoms in patients with PD. Patients aged 30 years or older who had a caregiver that could observe RBD symptoms were recruited between April 2015 and February 2016. The primary outcome was the Clinical Global Impressions-Improvement (CGII) score at week four, and we compared scores between the clonazepam and placebo groups. RESULTS:A total of 40 patients were enrolled, with 20 assigned to receiveclonazepam and 20 to receive the placebo. The CGI-I score at four weeks indicated an improvement in RBD symptoms in both the clonazepam (median score [minimum, maximum] = 2 [1,5]) and placebo (3 [1,6]) groups, with no significant difference between the groups (p = .253). The secondary outcomes were not significantly different between the clonazepam and placebo groups. CONCLUSIONS: Both clonazepam and placebo tended toward improvement on pRBD symptoms in patients with PD. No firm conclusion on efficacy of clonazepam was drawn due to limitations in the study design. This study emphasized the importance of conducting future large-scale, randomized trials with better assessment tools and polysomnography to provide evidence for the benefit of clonazepam.
RCT Entities:
BACKGROUND:Clonazepam is considered to be a first-line treatment for rapid eye movement sleep-related behavior disorder (RBD) in Parkinson's disease (PD). The purpose of this study was to determine the short-term efficacy and safety of clonazepam for the treatment of probable RBD (pRBD) in patients with PD. METHODS: We conducted a four-week, randomized, double-blind, placebo-controlled trial of clonazepam (0.5 mg/day at bedtime) compared to a placebo for RBD symptoms in patients with PD. Patients aged 30 years or older who had a caregiver that could observe RBD symptoms were recruited between April 2015 and February 2016. The primary outcome was the Clinical Global Impressions-Improvement (CGII) score at week four, and we compared scores between the clonazepam and placebo groups. RESULTS: A total of 40 patients were enrolled, with 20 assigned to receive clonazepam and 20 to receive the placebo. The CGI-I score at four weeks indicated an improvement in RBD symptoms in both the clonazepam (median score [minimum, maximum] = 2 [1,5]) and placebo (3 [1,6]) groups, with no significant difference between the groups (p = .253). The secondary outcomes were not significantly different between the clonazepam and placebo groups. CONCLUSIONS: Both clonazepam and placebo tended toward improvement on pRBD symptoms in patients with PD. No firm conclusion on efficacy of clonazepam was drawn due to limitations in the study design. This study emphasized the importance of conducting future large-scale, randomized trials with better assessment tools and polysomnography to provide evidence for the benefit of clonazepam.
Authors: Jun Sang Sunwoo; Young Ji Kim; Jung Ick Byun; Tae Joon Kim; Jin Sun Jun; Soon Tae Lee; Keun Hwa Jung; Kyung Il Park; Kon Chu; Manho Kim; Sang Kun Lee; Han Joon Kim; Carlos H Schenck; Ki Young Jung Journal: J Clin Neurol Date: 2020-04 Impact factor: 3.077
Authors: Moran Gilat; Alessandra Coeytaux Jackson; Nathaniel S Marshall; Deborah Hammond; Anna E Mullins; Julie M Hall; Bernard A M Fang; Brendon J Yee; Keith K H Wong; Ron R Grunstein; Simon J G Lewis Journal: Mov Disord Date: 2019-10-31 Impact factor: 10.338