@article{ref1,
title="Nicotine bitartrate reduces falls and freezing of gait in Parkinson disease: a reanalysis",
journal="Frontiers in neurology",
year="2019",
author="Lieberman, Abraham and Lockhart, Thurmon E. and Olson, Markey C. and Smith Hussain, Victoria A. and Frames, Christopher W. and Sadreddin, Arshia and McCauley, Margaret and Ludington, Elizabeth",
volume="10",
number="",
pages="e424-e424",
abstract="<b>Objective:</b> Determine if NC001, an oral formulation of nicotine that reduces levodopa-induced dyskinesias (LIDs) in MPTP-Parkinson monkeys, could reduce falls, freezing of gait (FOG), and LIDs in Parkinson disease (PD) patients. <b>Methods:</b> Previously collected data from a study analyzing the effects of NC001 on LIDs in PD patients were reanalyzed. Because indirect-acting cholinergic drugs are sometimes helpful in reducing falls, we hypothesized that NC001, a direct-acting cholinergic agonist, could reduce falls in PD. The original 12-center, double-blind, randomized trial enrolled 65 PD patients. NC001 or placebo was administered 4 times per day for 10 weeks, beginning at 4 mg/day and escalating to 24 mg/day. Assessments included the Unified Dyskinesia Rating Scale (UDysRS) and Parts II-III of the original Unified Parkinson's Disease Rating Scale (UPDRS). <b>Results:</b> Randomization (1:1) resulted in 35 patients on NC001 and 30 on placebo at baseline. Thirty and 27 patients, respectively, had data available for an intent-to-treat analysis. NC001 was safe and well-tolerated. After 10 weeks, NC001 patients (14/30) had a significant reduction in falls vs. placebo patients (3/27) (<i>p</i> = 0.0041) as assessed by UPDRS Part II. NC001 patients (12/30) also had significantly reduced FOG vs. placebo patients (4/27) (<i>p</i> = 0.0043). NC001 patients, compared with placebo patients, had a significant improvement (<i>p</i> = 0.01) in UDysRS ambulation subtest (40% vs. 3%, respectively). Although NC001 patients had a greater reduction in dyskinesias on the UDysRS than placebo patients (30% vs. 19%, respectively), this was not significant (<i>p</i> = 0.09). <b>Conclusions:</b> NC001 significantly improved two refractory symptoms of PD, falls and FOG. The reduction in falls and FOG is attributed to selective stimulation of nicotinic receptors. <b>Clinical Trial Registration:</b> Conducted under IND 105, 268, serial number 0000. ClinicalTrials.gov identifier NCT00957918.<p /> <p>Language: en</p>",
language="en",
issn="1664-2295",
doi="10.3389/fneur.2019.00424",
url="http://dx.doi.org/10.3389/fneur.2019.00424"
}