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

C

Cooper University Health Care

Status and phase

Suspended
Phase 4

Conditions

Parkinson Disease
Parkinsonism
Dyskinesias

Treatments

Drug: Zonegran

Study type

Interventional

Funder types

Other

Identifiers

NCT03034538
15-179

Details and patient eligibility

About

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).

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

100mg
Active Comparator group
Description:
Zonegran 100mg
Treatment:
Drug: Zonegran
200mg
Active Comparator group
Description:
Zonegran 200mg
Treatment:
Drug: Zonegran

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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