Study of Zonisamide in Early Parkinson Disease

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

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01766128

Acronym

ZONIST

Enrollment

Registered

2013-01-11

Start date

2013-02-28

Completion date

2013-02-28

Last updated

2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson disease, Early stage, Zonisamide, UPDRS

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.

Interventions

DRUGZonisamide

The first arm will be treated by zonisamide

DRUGPlacebo

The second arm will receive placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to need for dopaminergic therapy	Baseline and month 6

Secondary

Measure	Time frame
change in UPDRS score	Baseline and month 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026