Journal
JOURNAL OF THE NEUROLOGICAL SCIENCES
Volume 430, Issue -, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.jns.2021.120026
Keywords
Zonisamide; Parkinson's disease; Wearing off; Dyskinesia
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This study found that zonisamide can improve wearing off in patients with PD without exacerbating dyskinesia, with the 50 mg dose potentially benefiting the improvement of dyskinesia. Further research is needed to determine the clinical relevance and benefits of zonisamide on dyskinesia more clearly.
Introduction: Although phase 2 and 3 clinical trials in Japan showed that zonisamide improved wearing off in patients with Parkinson's disease (PD), no studies to date have evaluated whether zonisamide improves wearing off in patients with PD without exacerbating dyskinesia. Therefore, we examined this hypothesis in a post hoc analysis of pooled data from the previous phase 2 and 3 trials. Methods: Both trials evaluated zonisamide 25 mg and 50 mg versus placebo during a 12-week treatment period. In our analysis, primary efficacy variables were adjusted mean change in wearing off (evaluated as change in off time) and dyskinesia from baseline to 12 weeks. Dyskinesia was evaluated using Unified Parkinson's Disease Rating Scale (UPDRS) part 4 items 32 (4-32; duration of dyskinesia) and 33 (4-33; disability of dyskinesia) score. Criteria outcomes included rates of patients meeting specific criteria based on off time plus UPDRS part 432 or 4-33. Results: A total of 212 patients were included in this analysis. Zonisamide 50 mg significantly reduced off time and UPDRS part 4-33 score at week 12 versus placebo without increasing UPDRS part 4-32 score. The proportion of patients receiving zonisamide 50 mg who met the criterion Off time decreased and UPDRS part 4-33 score did not increase was significantly higher than that of patients receiving placebo. Conclusion: Zonisamide improves wearing off without exacerbating dyskinesia in Japanese patients with PD. Moreover, zonisamide 50 mg may improve dyskinesia. Further studies are needed to prospectively determine the benefits and clinical relevance of zonisamide on dyskinesia.
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