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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Withdrawn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
Mazandaran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Early stage, Zonisamide, UPDRS

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 45-85 years
  2. Symptoms and signs of idiopathic Parkinson disease for less than a month that do not lead to physical or psychosocial disability.

Exclusion Criteria:

  1. Past history of treatment with antiparkinson drugs.
  2. Past history of treatment with zonisamide
  3. Hepatic insufficiency (ALT>2ULN)
  4. Renal insufficiency (Cr>2mg/dl)
  5. Self or family history of nephrolithiasis
  6. Active psychosis
  7. Epilepsy
  8. Suicidal attempt in last 3 years
  9. Hypersensitivity to sulfonamides
  10. 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

    First Posted
    January 8, 2013
    Last Updated
    April 8, 2022
    Sponsor
    Mazandaran University of Medical Sciences
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    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    Withdrawn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

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