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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Zonisamide

Criteria

Inclusion Criteria:

1 -Age older than 18 years of both male and female genders. 2-Individuals diagnosed with PD based on the presence of 2 of 3 cardinal features & UK bank criteria for idiopathic Parkinson's disease. 3-Patients with motor complications of PD (Hoehn and Yahr stage 2-3)(on therapy) and at least 2 hours off time.

Exclusion Criteria:

1 -Patients with atypical or secondary Parkinsonism syndromes excluding PD. 2-Patients who could not perform the tests. 3-Women who were or might be pregnant, who did not practice effective contraception and were of childbearing potential, or who were breastfeeding.