A Multi-Center Controlled Screening Trial of Safety and Efficacy of Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 10
- 主要终点
- Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
研究概览
简要总结
ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and loss of muscle function. While there are drugs to help relieve symptoms of ALS, there is no cure for ALS.
Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means that the nervous system may be protected against weakening. It is known that rasagiline has possible neuroprotective characteristics and it is approved for use for patients with another disorder, the effectiveness of rasagiline for patients with ALS has not been tested.
详细描述
The specific aim of this screen study is to determine whether rasagiline is safe in this patient population and if the drug has the potential to slow ALS disease progression
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria, by the study investigator (Appendix IV).
- •21 to 80 years of age inclusive.
- •VC greater or equal to 75% of predicted at screening and baseline.
- •Onset of weakness within 3 years prior to enrollment.
- •If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit.
- •Women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test.
- •Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
- •Exclusion criteria
- •Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per day.
- •Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine.
- •Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphen, flexeril.
- •Patients on fluoxetine or fluvoxamine.
- •Patients taking amitriptyline > 50 mg/d, trazodone and sertraline > 100 mg/d, citalogram > 20 mg/d or paroxetine > 30 mg/d.
- •Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
- •Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
- •History of renal disease.
- •History of liver disease.
- •Current pregnancy or lactation.
- •Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
- •History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
- •VC < 75% of predicted.
- •Receipt of any investigational drug within the past 30 days.
- •Women with the potential to become pregnant who are not practicing effective birth control.
排除标准
- 未提供
研究组 & 干预措施
rasagiline
Treated for 12 months with rasagiline 2mg orally, once daily.
干预措施: rasagiline (Drug)
结局指标
主要结局
Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)
时间窗: up to 12 months
The primary outcome measure is the difference in the rate of decline in function, as detected by the ALS Functional Rating Scale - Revised (ALSFRS-R) in patients taking rasagiline compared to a database of patients from randomized clinical trials conducted during 1997-2007. Minimum score is 0 (no function) to Maximum score is 48 (normal function)
次要结局
- Difference in Time to Treatment Failure(up to 12 months)
研究者
Yunxia Wang, MD
Assistant Professor
University of Kansas Medical Center