An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Unified Dyskinesia Rating Scale (UDysRS)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
100mg
Zonegran 100mg
干预措施: Zonegran (Drug)
200mg
Zonegran 200mg
干预措施: Zonegran (Drug)
结局指标
主要结局
Unified Dyskinesia Rating Scale (UDysRS)
时间窗: 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.
次要结局
- Parkinson's Disease Quality of Life Questionnaire (PDQ-39)(12 weeks)