Session Time: 1:45pm-3:15pm
Location: Hall 3FG
Objective: To evaluate the disease modifying potential of transdermal (TD) nicotine in early Parkinson’s disease (PD). For this explanatory purpose, the primary endpoint was the change in the total UPDRS (I-III) score between baseline and 60 weeks (52 weeks treatment, 8 weeks washout).
Background: Epidemiological studies have shown an inverse relation between PD and tobacco consumption. In vitro investigations suggest nicotine exerts multiple effects that may slow neurodegeneration in PD. The German and N. American Parkinson Study Groups sought to investigate the disease-modifying effect of TD nicotine on the progression of early PD.
Methods: PD subjects within 18 months of diagnosis, Hoehn & Yahr stage ≤2, not requiring dopaminergic therapy, with or without stable (≥8 weeks) MAOBI therapy were randomized 1:1 to TD nicotine (up to 28 mg/day) or placebo. Differences in total UPDRS change from baseline to 60 weeks and 52 weeks (secondary pragmatic purpose) between groups were estimated using the Hodges-Lehmann (HL) method and tested using the exact 2-sided stratified Mann-Whitney-Wilcoxon test in the intent-to-treat-population.
Results: 163 subjects were randomized (61 at 11 US centers; 102 at 13 Germany centers), 1 excluded before treatment started. Baseline traits were similar in both arms [Table 1]. N=96 completed per protocol with 101 analyzed for the primary endpoint: mean worsening of total UPDRS was 3.5 in placebo (N=54) vs 6.0 in the nicotine arm (N=47), (HL difference with 95% CI: 3 [0, 6], p=0.0560). Drop out was almost exclusive due to early stop of treatment or major deviations from required assessments. N=138 were analyzed at 52 weeks with worsening of 5.4 in placebo (N=74) vs 9.1 in the nicotine arm (N=64), (4 [1, 7], p=0.0100). Cutaneous adverse effects were most common [Table 2]. 29% (23 placebo, 24 nicotine) initiated symptomatic therapy.
Conclusions: TD nicotine does not slow progression in early PD. In contrast to the hypothesis, nicotine may exert an accelerating effect as evidenced by worsened UPDRS scores compared to placebo.
To cite this abstract in AMA style:W. Oertel, H. Müller, C. Schade-Brittinger, C. Kamp, K. Balthasar, K. Articus, M. Brinkman, C. Venuto, M. Unger, K. Eggert, D. Vadasz, K. Kieburtz, J. Boyd. The NIC-PD-study –A randomized, placebo-controlled, double-blind, multi-centre trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson‘s disease in Germany and N. America [abstract]. Mov Disord. 2018; 33 (suppl 2). https://www.mdsabstracts.org/abstract/the-nic-pd-study-a-randomized-placebo-controlled-double-blind-multi-centre-trial-to-assess-the-disease-modifying-potential-of-transdermal-nicotine-in-early-parkinsons-disease-in-g/. Accessed December 1, 2023.
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