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

Primary Purpose

Parkinson Disease, Parkinsonism, Dyskinesias

Status
Suspended
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zonegran
Zonegran
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cooper University Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

100mg

200mg

Arm Description

Zonegran 100mg

Zonegran 200mg

Outcomes

Primary Outcome Measures

Unified Dyskinesia Rating Scale (UDysRS)
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

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

Full Information

First Posted
January 25, 2017
Last Updated
November 15, 2021
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03034538
Brief Title
An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease
Official Title
An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Suspended
Why Stopped
Site staffing
Study Start Date
April 8, 2016 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Parkinsonism, Dyskinesias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
100mg
Arm Type
Active Comparator
Arm Description
Zonegran 100mg
Arm Title
200mg
Arm Type
Active Comparator
Arm Description
Zonegran 200mg
Intervention Type
Drug
Intervention Name(s)
Zonegran
Intervention Description
100mg
Intervention Type
Drug
Intervention Name(s)
Zonegran
Intervention Description
200mg
Primary Outcome Measure Information:
Title
Unified Dyskinesia Rating Scale (UDysRS)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
Description
The 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cooper University Health System
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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