MedDataX Logo

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

NCT ID: NCT03034538

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-08

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Parkinsonism Dyskinesias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

100mg

Zonegran 100mg

Group Type ACTIVE_COMPARATOR

Zonegran

Intervention Type DRUG

100mg

200mg

Zonegran 200mg

Group Type ACTIVE_COMPARATOR

Zonegran

Intervention Type DRUG

200mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zonegran

100mg

Intervention Type DRUG

Zonegran

200mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Cooper Health System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cooper University Health System

Camden, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-179

Identifier Type: -

Identifier Source: org_study_id