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

Phase 4

Suspended

• Conditions: Parkinsonism; Parkinson Disease; Dyskinesias
• Interventions: Drug: Zonegran

• Registration Number: NCT03034538
• Lead Sponsor: The Cooper Health System

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-08
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-27
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-23
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of PD
• Identified dyskinesias of the limbs or trunk as agreed upon by subject and investigator, with dyskinesias considered moderately to completely disabling (UPDRS question 33, greater or equal to 2)
• Able to provide informed consent and swallow capsules
• Stable doses of dopaminergic therapy for 2 weeks before and expected throughout the study.

Exclusion Criteria

• Atypical parkinsonism
• Concurrent use of amantadine or active DBS where patient has some control over settings
• Prior surgery for PD
• Sulfa allergy or intolerance of zonisamide
• Significant concomitant medical illness in the opinion of the Principal Investigator (renal disease, liver disease)
• Pregnant subject or a subject who plans to become pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
200mg	Zonegran	Zonegran 200mg
100mg	Zonegran	Zonegran 100mg

Primary Outcome Measures

Name	Time	Method
Unified Dyskinesia Rating Scale (UDysRS)	12 weeks	assesses involuntary movements encountered in the treatment of Parkinson's Disease. It consists of a Historical Section, divided into questionnaires about 1) on-dyskinesia and 2) off -dystonia, and an Objective Section, divided into 3) impairment and 4) disability scales. The Historical Section is scored from 0-60, and the Objective section is scored 0-44, where higher scores reflect greater difficulty or impairment.

Secondary Outcome Measures

Name	Time	Method
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)	12 weeks	The 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD.

Trial Locations

Locations (1)

Cooper University Health System; 🇺🇸 Camden, New Jersey, United States