Dyskinesias, Parkinson Disease, Parkinsonism
Conditions
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).
Interventions
DRUGZonegran
100mg
Sponsors
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed