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An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease
In this 12-week, open-label pilot study, the investigators will enroll 20 subjects with Parkinson's Disease to determine if two doses of Zonisamide are tolerable and demonstrate clinical benefit for Dyskinesias. The primary outcome measure is tolerability, as determined by number of subjects able to complete the study on their originally assigned dosage. Secondary outcome measures will use the Unified Dyskinesia Rating Scale (UDysRS), comprised of an Objective Section and a Historical Section, to compare baseline to 6 and 12-week measurements. Additional analysis of the effect of Zonisamide on quality of life will be measured by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).
Details
| Lead sponsor | The Cooper Health System |
|---|---|
| Phase | PHASE4 |
| Status | SUSPENDED |
| Enrolment | 20 |
| Start date | Fri Apr 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sat Dec 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Parkinson Disease
- Parkinsonism
- Dyskinesias
Interventions
- Zonegran
- Zonegran
Countries
United States