An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT03034538
Recruitment Status : Unknown
Verified January 2017 by The Cooper Health System. Recruitment status was: Recruiting
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).
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) [ Time Frame: 12 weeks ]
The 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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