drugset / Trial / NCT04182399

Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot Study

NCT04182399

Completed 69 enrolled Ain Shams University
RandomizedCrossoverTriple-blindTreatment

Summary

Zonisamide (ZNS) (1,2-Benzisoxazole-3-methanesulfonamide) is an anti-epileptic drug. In three double blinded placebo controlled studies, ZNS- as an adjunctive treatment- showed beneficial effects on motor symptoms of PD with a low incidence of adverse events. As a result 25 mg daily of ZNS was approved in 2009 in Japan as an adjunctive treatment in PD patients whose condition responded insufficiently to Levodopa treatment. Most observations of a beneficial effect of ZNS have been in Japanese people, and the antiparkinsonian mechanism of action is unclear. So, ZNS is a promising but still investigational drug to treat PD and more studies are warranted. this study will investigate the efficacy and tolerability of Zonisamide as an adjunctive treatment in Egyptian patients with advanced PD, including motor fluctuations, levodopa induced dyskinesia and existing nonmotor symptoms. Additionally it investigates its effects on quality of life of PD patients.

Timeline

Start
2020-04-01
Primary completion
2022-12-01
Completion
2023-01-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Zonisamide Other / unclassified 25 mg Oral
Comparator Zonisamide Other / unclassified 50 mg Oral

Indications