Dystonia is a painful OFF-related complication in Parkinson's disease (PD) with limited treatment options. analysis using pooled data from two extended-release amantadine pivotal trials and follow-on open-label extension. Dystonia was assessed using the Unified Dyskinesia Rating Scale (UDysRS) Part 2 and the Movement Disorder Society-Unified PD Rating Scale (MDS-UPDRS) item 4.6. Of 196 participants, 119 (60.7%) reported OFF-related dystonia at baseline per UDysRS. Twelve-week treatment with extended-release amantadine improved OFF dystonia (treatment differences vs placebo: UDysRS Part 2, -1.0 [-1.9,-0.1]; p = 0.03 and MDS-UPDRS Item 4.6, −0.3[-0.6,-0.05]; p = 0.02). There was no correlation between changes in OFF time and changes in OFF dystonia. Double-blind improvements in OFF dystonia were sustained throughout the 2-year follow-up. Extended-release amantadine yielded a sustained reduction in OFF-related dystonia in PD patients that was independent from a reduction in OFF time. A randomized controlled trial is warranted to confirm these findings.

中文翻译：

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缓释金刚烷胺治疗帕金森病 OFF 相关肌张力障碍

肌张力障碍是帕金森病 (PD) 中一种与 OFF 相关的痛苦并发症，治疗选择有限。使用来自两项缓释金刚烷胺关键试验和后续开放标签扩展的汇总数据进行分析。使用统一运动障碍评定量表 (UDysRS) 第 2 部分和运动障碍协会统一 PD 评定量表 (MDS-UPDRS) 第 4.6 项评估肌张力障碍。在 196 名参与者中，有 119 名 (60.7%) 在基线时报告了与 UDysRS 相关的肌张力障碍。缓释金刚烷胺治疗 12 周改善了 OFF 肌张力障碍（与安慰剂相比治疗差异：UDysRS 第 2 部分，-1.0 [-1.9，-0.1]；p = 0.03 和 MDS-UPDRS 项目 4.6，-0.3[-0.6，-0.05） ]；p = 0.02）。OFF 时间的变化与 OFF 肌张力障碍的变化之间没有相关性。在整个 2 年随访期间，OFF 肌张力障碍的双盲改善持续存在。缓释金刚烷胺可持续减少 PD 患者的 OFF 相关肌张力障碍，且与 OFF 时间的减少无关。有必要进行随机对照试验来证实这些发现。