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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 November 2021 |
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Main ID: |
NCT03034538 |
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Date of registration:
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25/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease
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Scientific title:
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An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease |
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Date of first enrolment:
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April 8, 2016 |
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Target sample size:
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20 |
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Recruitment status: |
Suspended |
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URL:
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https://clinicaltrials.gov/show/NCT03034538 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinsonism
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Dyskinesias
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Parkinson Disease
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Intervention(s)
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Drug: Zonegran
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Primary Outcome(s)
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Unified Dyskinesia Rating Scale (UDysRS)
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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