Efficacy of Pramipexole Extended Release in the Treatment of Essential Tremor: a Double-blind, Cross-over, Placebo-controlled Multicenter Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Improvement in tremor severity
研究概览
简要总结
Aim of the study is to perform a double-blind, crossover, placebo-controlled multicenter study evaluating the efficacy of pramipexole on essential tremor.
详细描述
Essential tremor is one of the most common movement disorders with the prevalence of 3-5% among the elderly population. Although its main clinical feature is the bilateral, predominantly postural-kinetic tremor, newer studies suggest that ET is a spectrum of clinical features with both motor and nonmotor elements not homogeneously distributed.
Despite its high occurrence, the pharmacological treatment of ET is limited. Although the mainline drugs, propranolol and primidone, can provide good clinical benefit in a portion of cases, >50% of the patients stop the medication due to inefficacy or side-effects. Hypotension, dizziness, bradycardia, cognitive impairment, fatigue and erectile dysfunction are the most common side-effects contributing to medication discontinuation.
In an open-label pilot study, the investigators previously demonstrated that 2.1 mg/day pramipexole extended-release improved both the severity of tremor (by 52%) and health-related quality of life.
The present study aims to confirm this hypothesis in a double-blind, crossover, placebo-controlled multicenter study.
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
- Quadruple (Participant, Care Provider, 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
- •Diagnosis of ET has to be unambiguous based on the clinical diagnostic criteria.
- •Tremor has to be severe enough to produce disability.
- •Patients must sign a written informed consent according with the approval of the Regional Ethical Board of University of Pécs
排除标准
- •Exclusion criteria are established in accordance to the guidelines of Elble et al
- •Presence of any medical conditions capable of producing tremor (e.g. hyperthyroidism, drug withdrawal, neuropathy, etc.).
- •Except for cogwheel phenomenon, the presence of any abnormal neurological signs (e.g. dystonia, myoclonus, ataxia, parkinsonism, cerebellar or pyramidal signs, etc.)
- •Atypical tremor appearance for ET (e.g. isolated vocal-cord tremor, orthostatic tremor, task-specific tremor, etc.)
- •Presence or suspicion of psychogenic tremor
- •Usage of medication capable of producing tremor (e.g. sympathomimetics, valproate, etc.)
- •Concomitant administration of any drugs potentially capable of improving ET (e.g. antiepileptics, beta-receptor blockers).
- •Previous neurosurgical treatment (e.g. deep brain stimulation or thalamotomy).
- •Presence of serious concomitant disorders capable of interfering with the study (e.g. heart failure, tumorous disorders, etc.)
- •Presence of any contraindication for pramipexole treatment (e.g. impulsive control disorder, known hypersensitivity to any components of the tablets, etc.)
研究组 & 干预措施
Process 2
10 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment
干预措施: pramipexole (Drug)
Process 1
10 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment
干预措施: pramipexole (Drug)
Process 1
10 weeks of pramipexole treatment 2 weeks wash-out period (cross-over) 10 weeks placebo treatment
干预措施: placebo (Drug)
Process 2
10 weeks of placebo treatment 2 weeks wash-out period (cross-over) 10 weeks pramipexole treatment
干预措施: placebo (Drug)
结局指标
主要结局
Improvement in tremor severity
时间窗: 10 weeks of treatment
Improvement in tremor severity measured by Fahn-Tolosa-Marin Tremor Rating Scale
次要结局
- Improvement in quality of life(10 weeks of treatment)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(10 weeks of treatment)
研究者
Dr. Norbert Kovacs
Associate professor, specialist in neurology and movement disorders, Department of Neurology
University of Pecs