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Neurological Sciences

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Open Access 20-02-2024 | Zonisamide | Clinical Trial article

Role of zonisamide in advanced Parkinson’s disease: a randomized placebo-controlled study

Authors: Mohamed Essam, Eman Hamid, Eman Abushady, Mahmoud El-Balkimy, Angelo Antonini, Ali Shalash

Published in: Neurological Sciences | Issue 4/2024

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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Title: Role of zonisamide in advanced Parkinson’s disease: a randomized placebo-controlled study
Authors: Mohamed Essam
Eman Hamid
Eman Abushady
Mahmoud El-Balkimy
Angelo Antonini
Ali Shalash
Publication date: 20-02-2024
Publisher: Springer International Publishing
Keywords: Zonisamide
Parkinson's Disease
Tremor
Published in: Neurological Sciences / Issue 4/2024
Print ISSN: 1590-1874
Electronic ISSN: 1590-3478
DOI: https://doi.org/10.1007/s10072-024-07396-w

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Role of zonisamide in advanced Parkinson’s disease: a randomized placebo-controlled study

Abstract

Background

Methods

Results

Conclusion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Trial registration

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