Study of Zonisamide in Early Parkinson Disease

NCT01766128 | Withdrawn Phase 2

• 1 other identifier: ZEPD-1091
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; Early stage; Zonisamide; UPDRS

Outcome Measures

Primary Outcomes (1)

• Time to need for dopaminergic therapy

  Baseline and month 6

Secondary Outcomes (1)

• change in UPDRS score

  Baseline and month 12

Study Arms (2)

Zonisamide

ACTIVE COMPARATOR

The patients in this arm are treated with zonisamide 50mg/d

Drug: Zonisamide

Placebo

PLACEBO COMPARATOR

The patients in this arm are treated with placebo

Drug: Placebo

Interventions

Zonisamide DRUG

The first arm will be treated by zonisamide

Zonisamide

Placebo DRUG

The second arm will receive placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Masoud Etemadifar

  IUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of neurology

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 11, 2013
• Study Start: February 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 14, 2022

Record last verified: 2022-04