Study of Zonisamide in Early Parkinson Disease

Phase 2

Withdrawn

• Conditions: Parkinson Disease
• Interventions: Drug: Placebo; Drug: Zonisamide

• Registration Number: NCT01766128
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Study Start: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The patients in this arm are treated with placebo
Zonisamide	Zonisamide	The patients in this arm are treated with zonisamide 50mg/d

Primary Outcome Measures

Name	Time	Method
Time to need for dopaminergic therapy	Baseline and month 6

Secondary Outcome Measures

Name	Time	Method
change in UPDRS score	Baseline and month 12