Study of Zonisamide in Early Parkinson Disease

Parkinson Disease Clinical Trial

— ZONIST  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01766128
• Other study ID #: ZEPD-1091
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: February 2013
• Est. completion date: February 2013

Study information

• Verified date: April 2022
• Source: Mazandaran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Zonisamide
The first arm will be treated by zonisamide
• Placebo
The second arm will receive placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to need for dopaminergic therapy		Baseline and month 6
Secondary	change in UPDRS score		Baseline and month 12