Article ; Online: Role of zonisamide in advanced Parkinson's disease: a randomized placebo-controlled study.
2024 Volume 45, Issue 4, Page(s) 1725–1734
Abstract: Background: Zonisamide (ZNS) has shown some efficacy in motor symptoms of PD; however, more evidence is lacking, and its effects on nonmotor symptoms (NMSs) and quality of life (QoL) remain to be investigated. This randomized double-blinded placebo- ... ...
Abstract | Background: Zonisamide (ZNS) has shown some efficacy in motor symptoms of PD; however, more evidence is lacking, and its effects on nonmotor symptoms (NMSs) and quality of life (QoL) remain to be investigated. This randomized double-blinded placebo-controlled crossover study investigated the effect of ZNS on motor and NMS symptoms and QoL in advanced PD. Methods: PD patients with Hoehn and Yahr stage ≥ 2 ("On" state) and at least 2 h off time daily were randomized to groups: ZNS 25 mg, ZNS 50 mg and placebo. Groups were assessed at baseline and at the 1- and 3-month follow-ups. The primary endpoint was the change in the total MDS-UPDRS III "On", while the secondary endpoint was the change in the total and parts I and IV MDS-UPDRS, Nonmotor Symptoms Scale and Parkinson's disease questionnaire-39 at the final assessment. Results: Sixty-nine patients were assessed for efficacy at the 1-month follow-up, and 58 patients were assessed at the 3-month follow-up. The primary endpoint showed significant improvement in the ZNS 25 mg group compared to the placebo group (p = 0.009). At the final assessment, the ZNS 25 mg group showed significant improvement of total and part VI MDS-UPDRS, bradykinesia, tremor and functional impact of fluctuations compared to placebo. There was no change in dyskinesia, NMSs, QoL or side effects except for sedation. Conclusion: ZNS has a favourable effect on motor symptoms in patients with wearing off as adjunctive therapy with other dopaminergic drugs, with no exacerbation of dyskinesia and a limited impact on NMSs and QoL. Trial registration: Clinicaltrials.gov, NCT04182399, in 24/11/2019. |
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MeSH term(s) | Humans ; Zonisamide/therapeutic use ; Parkinson Disease/complications ; Quality of Life ; Cross-Over Studies ; Tremor/complications |
Chemical Substances | Zonisamide (459384H98V) |
Language | English |
Publishing date | 2024-02-20 |
Publishing country | Italy |
Document type | Randomized Controlled Trial ; Journal Article |
ZDB-ID | 2016546-8 |
ISSN | 1590-3478 ; 1590-1874 |
ISSN (online) | 1590-3478 |
ISSN | 1590-1874 |
DOI | 10.1007/s10072-024-07396-w |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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