Study of Zonisamide in Early Parkinson Disease (ZONIST)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Mazandaran University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Nasim Tabrizi, Mazandaran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01766128
First received: January 8, 2013
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Mazandaran University of Medical Sciences:

Primary Outcome Measures:
  • Time to need for dopaminergic therapy [ Time Frame: Baseline and month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in UPDRS score [ Time Frame: Baseline and month 12 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01766128

Contacts
Contact: Nasim Tabrizi 00989111263538 nasimtabrizi@gmail.com

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

No publications provided

Responsible Party: Nasim Tabrizi, Assistant professor of neurology, Mazandaran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01766128     History of Changes
Other Study ID Numbers: ZEPD-1091
Study First Received: January 8, 2013
Last Updated: January 9, 2013
Health Authority: Iran:MAZUMS ethic commetee

Keywords provided by Mazandaran University of Medical Sciences:
Parkinson disease
Early stage
Zonisamide
UPDRS

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Zonisamide
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014