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

NCT03034538 | Suspended Phase 4 FDA Drug

• 1 other identifier: 15-179
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease; Parkinsonism; Dyskinesias

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Parkinson's Disease Quality of Life Questionnaire (PDQ-39)

  12 weeks

Study Arms (2)

100mg

ACTIVE COMPARATOR

Zonegran 100mg

Drug: Zonegran

200mg

ACTIVE COMPARATOR

Zonegran 200mg

Drug: Zonegran

Interventions

Zonegran DRUG

100mg

100mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Health System

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Dyskinesias

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: April 8, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)