Study of Zonisamide in Early Parkinson Disease

Study Overview
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Brief Summary
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The aim of this study is investigation of neuroprotective effect of zonisamide in early Parkinson disease. A total of 60 patients with early Parkinson disease who meet the study criteria will be enrolled and randomized into two groups alternately based on their visit date. Demographic data, Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn&Yahr and modified Schwab&England activities of daily living scale will be determined and registered for each patient. Patients of group A will be treated by zonisamide 50mg/d for 12 months and the other group will be treated by placebo for the same time. Primary endpoint is occurrence of parkinsonian symptoms which interfere with patients' daily activity or cause psychosocial embarrassment. The mentioned scores will be registered every 2 months for both groups by blinded neurologist and also regular blood test will be performed to prevent drug adverse events.

Official Title
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Randomized Double Blind Placebo-controlled Study of Zonisamide Effectiveness in Early Parkinson Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Zonisamide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45-85 years Symptoms and signs of idiopathic Parkinson disease for less than a month that do not lead to physical or psychosocial disability. Exclusion Criteria: Past history of treatment with antiparkinson drugs. Past history of treatment with zonisamide Hepatic insufficiency (ALT>2ULN) Renal insufficiency (Cr>2mg/dl) Self or family history of nephrolithiasis Active psychosis Epilepsy Suicidal attempt in last 3 years Hypersensitivity to sulfonamides Pregnancy and breastfeeding

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zonisamide<br>The patients in this arm are treated with zonisamide 50mg/d | Drug: Zonisamide<br>* The first arm will be treated by zonisamide<br>|
| Placebo Comparator: Placebo<br>The patients in this arm are treated with placebo | Drug: Placebo<br>* The second arm will receive placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to need for dopaminergic therapy |  | Baseline and month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in UPDRS score |  | Baseline and month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson disease, Early stage, Zonisamide, UPDRS