NCT01766128

Study of Zonisamide in Early Parkinson Disease

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mazandaran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Zonisamide	The first arm will be treated by zonisamide
DRUG	Placebo	The second arm will receive placebo

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2013-01-11
• Last updated: 2022-04-14