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
About this trial
This is an interventional treatment trial for Parkinson Disease
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
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
NCT ID
NCT03034538
First Posted
January 25, 2017
Last Updated
November 15, 2021
Sponsor
The Cooper Health System
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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