NCT00584376已完成4 期
A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 8
- 主要终点
- Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score
研究概览
简要总结
This will be a multi-site, prospective, double-blind, randomized, placebo-controlled, crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to treat symptoms of ET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with essential tremor diagnosed by a movement disorder specialist.
- •Age 18 years to 80 years.
- •Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale.
- •Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
- •Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year).
- •Serum creatine kinase, complete metabolic blood count, liver function tests, renal function tests, and platelets are within normal limits (blood drawn within the past year).
- •Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
排除标准
- •Any illness that in the investigator's opinion preclude participation in this study.
- •Pregnancy or lactation.
- •Concurrent participation in another clinical study.
- •Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
- •Legal incapacity or limited legal capacity.
- •Presence of severe renal disease (BUN 50% greater than normal or creatine clearance <60 mL/min) or hepatic disease.
- •Presence of severe daytime sleepiness.
- •Abnormal creatine kinase and/or platelet count in the past year.
- •Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
- •Previous lack of response to other ET therapies (propranolol AND primidone).
- •Patients who have had deep brain stimulation (DBS).
- •Concomitant treatment with gabapentin.
研究组 & 干预措施
1
Active Comparator
Pregabalin
干预措施: Pregabalin (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score
时间窗: 61 days
次要结局
- Writing tablet recordings of tremor amplitude(61 days)
研究者
Theresa Zesiewicz
Professor
University of South Florida
研究点 (8)
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