Study of Zonisamide in Early Parkinson Disease (ZONIST)

April 8, 2022 updated by: Nasim Tabrizi, Mazandaran University of Medical Sciences

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Zonisamide
The patients in this arm are treated with zonisamide 50mg/d
Drug: Zonisamide
The first arm will be treated by zonisamide
PLACEBO_COMPARATOR: Placebo
The patients in this arm are treated with placebo
Drug: Placebo
The second arm will receive placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to need for dopaminergic therapy
Time Frame: Baseline and month 6
Baseline and month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
change in UPDRS score
Time Frame: Baseline and month 12
Baseline and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mazandaran University of Medical Sciences

Investigators

  • Principal Investigator: Masoud Etemadifar, IUMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2013

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 9, 2013

First Posted (ESTIMATE)

January 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZEPD-1091

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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