An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03034538
• Other study ID #: 15-179
• Status: Suspended
• Phase: Phase 4
• Start date: April 8, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this 12-week, open-label pilot study, the investigators will enroll 20 subjects with Parkinson's Disease to determine if two doses of Zonisamide are tolerable and demonstrate clinical benefit for Dyskinesias. The primary outcome measure is tolerability, as determined by number of subjects able to complete the study on their originally assigned dosage. Secondary outcome measures will use the Unified Dyskinesia Rating Scale (UDysRS), comprised of an Objective Section and a Historical Section, to compare baseline to 6 and 12-week measurements. Additional analysis of the effect of Zonisamide on quality of life will be measured by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of PD

• Identified dyskinesias of the limbs or trunk as agreed upon by subject and investigator, with dyskinesias considered moderately to completely disabling (UPDRS question 33, greater or equal to 2)

• Able to provide informed consent and swallow capsules

• Stable doses of dopaminergic therapy for 2 weeks before and expected throughout the study.

Exclusion Criteria:

• Atypical parkinsonism

• Concurrent use of amantadine or active DBS where patient has some control over settings

• Prior surgery for PD

• Sulfa allergy or intolerance of zonisamide

• Significant concomitant medical illness in the opinion of the Principal Investigator (renal disease, liver disease)

• Pregnant subject or a subject who plans to become pregnant

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease
• Parkinsonian Disorders
• Parkinsonism

Intervention

Drug:
• Zonegran
100mg
• Zonegran
200mg

Locations

Country	Name	City	State
United States	Cooper University Health System	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Dyskinesia Rating Scale (UDysRS)	assesses involuntary movements encountered in the treatment of Parkinson's Disease. It consists of a Historical Section, divided into questionnaires about 1) on-dyskinesia and 2) off -dystonia, and an Objective Section, divided into 3) impairment and 4) disability scales. The Historical Section is scored from 0-60, and the Objective section is scored 0-44, where higher scores reflect greater difficulty or impairment.	12 weeks
Secondary	Parkinson's Disease Quality of Life Questionnaire (PDQ-39)	The 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD.	12 weeks