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Study of Zonisamide in Early Parkinson Disease (ZONIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01766128
Recruitment Status : Withdrawn (Practical problems)
First Posted : January 11, 2013
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Nasim Tabrizi, Mazandaran University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Zonisamide Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double Blind Placebo-controlled Study of Zonisamide Effectiveness in Early Parkinson Disease
Actual Study Start Date : February 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Zonisamide

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




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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766128


Sponsors and Collaborators
Mazandaran University of Medical Sciences
Investigators
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Principal Investigator: Masoud Etemadifar IUMS
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Responsible Party: Nasim Tabrizi, Assistant professor of neurology, Mazandaran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01766128    
Other Study ID Numbers: ZEPD-1091
First Posted: January 11, 2013    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022

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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
Keywords provided by Nasim Tabrizi, Mazandaran University of Medical Sciences:
Parkinson disease
Early stage
Zonisamide
UPDRS
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Zonisamide
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs