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Study of Zonisamide in Early Parkinson Disease (ZONIST)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Nasim Tabrizi, Mazandaran University of Medical Sciences.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Nasim Tabrizi, Mazandaran University of Medical Sciences Identifier:
First received: January 8, 2013
Last updated: January 9, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Parkinson Disease
Drug: Zonisamide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Placebo-controlled Study of Zonisamide Effectiveness in Early Parkinson Disease

Resource links provided by NLM:

Further study details as provided by Nasim Tabrizi, Mazandaran University of Medical Sciences:

Primary Outcome Measures:
  • Time to need for dopaminergic therapy [ Time Frame: Baseline and month 6 ]

Secondary Outcome Measures:
  • change in UPDRS score [ Time Frame: Baseline and month 12 ]

Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zonisamide
The patients in this arm are treated with zonisamide 50mg/d
Drug: Zonisamide
The first arm will be treated by zonisamide and the second one will only receive placebo
Placebo Comparator: Placebo
The patients in this arm are treated with placebo


Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01766128

Contact: Nasim Tabrizi 00989111263538

Sponsors and Collaborators
Mazandaran University of Medical Sciences
Principal Investigator: Masoud Etemadifar IUMS
  More Information

Responsible Party: Nasim Tabrizi, Assistant professor of neurology, Mazandaran University of Medical Sciences Identifier: NCT01766128     History of Changes
Other Study ID Numbers: ZEPD-1091
Study First Received: January 8, 2013
Last Updated: January 9, 2013

Keywords provided by Nasim Tabrizi, Mazandaran University of Medical Sciences:
Parkinson disease
Early stage

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs processed this record on May 25, 2017