Study of Zonisamide in Early Parkinson Disease (ZONIST)
Primary Purpose
Parkinson Disease
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Zonisamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Early stage, Zonisamide, UPDRS
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Zonisamide
Placebo
Arm Description
The patients in this arm are treated with zonisamide 50mg/d
The patients in this arm are treated with placebo
Outcomes
Primary Outcome Measures
Time to need for dopaminergic therapy
Secondary Outcome Measures
change in UPDRS score
Full Information
NCT ID
NCT01766128
First Posted
January 8, 2013
Last Updated
April 8, 2022
Sponsor
Mazandaran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01766128
Brief Title
Study of Zonisamide in Early Parkinson Disease
Acronym
ZONIST
Official Title
Randomized Double Blind Placebo-controlled Study of Zonisamide Effectiveness in Early Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Practical problems
Study Start Date
February 2013 (Actual)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mazandaran University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Early stage, Zonisamide, UPDRS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zonisamide
Arm Type
Active Comparator
Arm Description
The patients in this arm are treated with zonisamide 50mg/d
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patients in this arm are treated with placebo
Intervention Type
Drug
Intervention Name(s)
Zonisamide
Intervention Description
The first arm will be treated by zonisamide
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The second arm will receive placebo
Primary Outcome Measure Information:
Title
Time to need for dopaminergic therapy
Time Frame
Baseline and month 6
Secondary Outcome Measure Information:
Title
change in UPDRS score
Time Frame
Baseline and month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoud Etemadifar
Organizational Affiliation
IUMS
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of Zonisamide in Early Parkinson Disease
We'll reach out to this number within 24 hrs