Study of Zonisamide in Early Parkinson Disease (ZONIST)

Mazandaran University of Medical Sciences

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Placebo; Drug: Zonisamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01766128

ZEPD-1091

Details and patient eligibility

About

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.

Sex: All

Ages: 45 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Zonisamide

Active Comparator group

Description:

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

Treatment:

Drug: Zonisamide

Placebo

Placebo Comparator group

Description:

The patients in this arm are treated with placebo

Treatment:

Drug: Placebo