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

Sponsor

The Cooper Health System (Other)

Overall Status

Suspended

CT.gov ID

NCT03034538

Collaborator

(none)

Enrollment

Location

Arms

80.8

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Parkinsonism Dyskinesias	Drug: Zonegran Drug: Zonegran	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 8, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 100mg Zonegran 100mg	Drug: Zonegran 100mg
Active Comparator: 200mg Zonegran 200mg	Drug: Zonegran 200mg

Arm

Intervention/Treatment

Active Comparator: 100mg

Zonegran 100mg

Drug: Zonegran

100mg

Active Comparator: 200mg

Zonegran 200mg

Drug: Zonegran

200mg

Outcome Measures

Primary Outcome Measures

Unified Dyskinesia Rating Scale (UDysRS) [12 weeks]
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.

Secondary Outcome Measures

Parkinson's Disease Quality of Life Questionnaire (PDQ-39) [12 weeks]
The 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cooper University Health System	Camden	New Jersey	United States	08103

Sponsors and Collaborators

The Cooper Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Cooper Health System

ClinicalTrials.gov Identifier:

NCT03034538

Other Study ID Numbers:

15-179

First Posted:

Jan 27, 2017

Last Update Posted:

Nov 23, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Dyskinesias

Parkinsonian Disorders

Zonisamide

Study Results

No Results Posted as of Nov 23, 2021