NCT03034538

An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Parkinson Disease
• Parkinsonism
• Dyskinesias

Interventions

Type	Name	Description
DRUG	Zonegran	100mg
DRUG	Zonegran	200mg

Timeline

• Start date: 2016-04-08
• Primary completion: 2022-12-01
• Completion: 2022-12-31
• First posted: 2017-01-27
• Last updated: 2021-11-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study