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

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ClinicalTrials.gov Identifier: NCT03034538
Recruitment Status : Unknown
Verified January 2017 by The Cooper Health System.
Recruitment status was:  Recruiting
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
The Cooper Health System

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 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 8, 2016
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Zonisamide

Arm Intervention/treatment
Active Comparator: 100mg
Zonegran 100mg
Drug: Zonegran
100mg

Active Comparator: 200mg
Zonegran 200mg
Drug: Zonegran
200mg




Primary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 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 :
  1. Parkinson's Disease Quality of Life Questionnaire (PDQ-39) [ Time Frame: 12 weeks ]
    The 39-Item Parkinson's Disease Questionnaire (PDQ-39) is a commonly used measure of self-appraisal in PD.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034538


Locations
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United States, New Jersey
Cooper University Health System Recruiting
Camden, New Jersey, United States, 08103
Contact: Andrew March, BS    856-342-2460    march-andrew@cooperhealth.edu   
Principal Investigator: Andrew McGarry, MD         
Sub-Investigator: Amy Colcher, MD         
Sponsors and Collaborators
The Cooper Health System

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Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT03034538     History of Changes
Other Study ID Numbers: 15-179
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Zonisamide
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs