NCT01211587已完成2 期
A Double-blind, Randomized, Placebo-controlled, Parallel-group Phase II Study to Explore the Potential Beneficial Effects of Safinamide on Cognition in Non-demented Patients With Idiopathic Parkinson's Disease (PD) and Cognitive Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 15
- 主要终点
- Parkinson's Disease Cognitive Rating Scale (PD-CRS)
研究概览
简要总结
The purpose of this research trial is to determine if safinamide (experimental drug) can improve cognition in cognitively impaired but non-demented Parkinson's disease patients. The word "experimental" means the trial drug is not approved by Health Authorities (government authorities) and is still being tested for safety and effectiveness.
Approximately one hundred (100) patients will participate in this research trial. The research trial will be conducted in approximately thirty (30) medical centers in the following countries: Argentina, Canada, Italy, Peru, South Africa, Spain and USA. The research trial will last until June 2012.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients (aged 45 to 80 years inclusive)
- •Diagnosis of idiopathic Parkinson's Disease (PD) according to the UK PDS Brain Bank Criteria and a Hoehn and Yahr Stage of I to III (mild to moderate motor severity) at Screening. The diagnosis will be based on medical history and neurological examination
- •Subjects and informants must report cognitive impairment in at least one cognitive domain on the PD Cognitive Questionnaire (PD-CQ).
- •Cognitive impairment confirmed by a total score equal to- or below 26 on the Montreal Cognitive Assessment (MoCA)
- •Be able to speak, read, and write in the language in which the tests are written and must be able to perform all the assessments in this language
- •Receiving treatment with dopaminergic therapy (dopamine agonist and/or levodopa at a stable dose for at least four weeks prior to Screening and for the duration of the study)
- •Understand and sign the appropriate approved Informed Consent Form(s), one for the study (mandatory) and one for the pharmacogenetic evaluation (optional)
排除标准
- •Any indication of forms of Parkinsonism other than idiopathic PD
- •Diagnosis of PD Dementia (probable, possible) according to the Clinical Diagnostic Criteria for Dementia Associated with PD
- •Diagnosis of Dementia with Lewy Bodies according to the McKeith criteria.
- •Subjects with any clinically significant DSM-IV-TR Axis I Disorders including major depression and severe anxiety; current diagnosis of substance abuse or history of alcohol or drug abuse for 3 months prior to Visit 1 (Screening)
- •Mental/physical/social condition which could preclude performing efficacy or safety assessments
- •Severe white matter disease, multiple lacunar infarcts, or signs of significant vascular changes on Magnetic Resonance Imaging (MRI)
- •Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
- •Current history of severe dizziness or fainting on standing, due to postural hypotension
- •Second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction in the three months prior to Visit 1 (Screening), or significant electrocardiogram (ECG) abnormality, including heart-rate corrected interval QT (QTC) > 450 milliseconds (males) or > 470 milliseconds (females), with QTC based on the Bazett's correction method
- •Known diagnosis of human immunodeficiency virus (HIV) infection, positive results on tests for hepatitis B or C antibodies, or on tests for hepatitis B surface antigen (unless vaccinated)
- •Neoplastic disease, either currently active or in remission for less than 1 year
- •Clinically significant or unstable gastrointestinal, renal, hepatic, endocrine, pulmonary, or cardiovascular disease, including not well controlled hypertension, asthma, chronic obstructive pulmonary disease, and Type 1 diabetes that would, in the opinion of the Investigator, preclude participation to the study
- •Any clinically relevant abnormality, either on medical history, physical and neurological examination, ECG, or by diagnostic laboratory tests that, in the opinion of the Investigator, could hinder participation to the study
- •Currently experiencing end-of-dose wearing-off or on-off phenomena, disabling peak dose- or biphasic dyskinesia, or unpredictable or widely swinging fluctuations
- •Any medical conditions and/or taking concomitant medications that could put them at risk, interfere with study evaluations, or prevent meeting the requirements of the study
- •Currently participating to another clinical trial or who participated in a previous clinical trial within 30 days prior to Visit 1 (Screening) or who received any investigational product within 30 days or five half-lives, whichever was longer, prior to Visit 1 (Screening)
- •Previously treated with safinamide
- •Clinically significant hypertension or contraindications or hypersensitivity to monoamine oxidase-Type B (MAO-B) inhibitors
- •Anticholinergic medication and/or amantadine within 4 weeks prior to the Screening visit
- •Opioids (e.g., tramadol and meperidine derivatives) or MAO inhibitors (e.g., selegiline) within 8 weeks prior to Visit 1 (Screening) Dextromethorphan will be allowed to treat cough. One tricyclic- or tetracyclic antidepressant or trazodone will be permitted if taken at bedtime at a low dose as a sleeping aid
- •Acetylcholinesterase inhibitors or memantine within 4 weeks before start of the study treatment or requiring these medications during the treatment period
- •Depot neuroleptic during the study or within 1 injection cycle or oral neuroleptics (stable dose of quetiapine less than 100 mg/day for 8 weeks prior to Visit 1 will be allowed) within 4 weeks prior to Visit 1 (Screening)
- •Drug that has hepatotoxic potential (e.g., tamoxifen) within 4 weeks prior to Visit 1 (Screening), or radiation therapy, or a drug with cytotoxic potential (e.g., chemotherapy) within 1 year prior to the Screening visit.
- •Subjects who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study
- •Women who are pregnant, lactating, or who are attempting to conceive
- •Women of childbearing potential not willing to use an adequate contraceptive method (unless surgically sterilized) for 4 weeks prior to, during, and 4 weeks after the last dose of trial medication
- •Clinically significant ophthalmologic abnormality such as patients with albinism, family history of hereditary retinal disease, progressive and/or severe diminution of corrected visual acuity, retinitis pigmentosa, any active retinopathy or ocular inflammation (uveitis), or progressive, severe diabetic retinopathy
- •Known hypersensitivity to the trial treatment(s), including placebo or other comparator drug(s)
- •Legal incapacity or limited legal capacity
研究组 & 干预措施
100mg safinamide
Experimental
Two 50mg tablets of safinamide once per day for 12 weeks (weeks 1-12) Open Label part: Two 50mg tablets of safinamide once per day for 12 weeks (week 13-24)
干预措施: safinamide (Drug)
Placebo
Placebo Comparator
Two 50mg tablets of placebo once per day for 12 weeks (weeks 1-12) Open Label part: Two 50mg tablets of safinamide once per day for 12 weeks (week 13-24)
干预措施: placebo (Drug)
结局指标
主要结局
Parkinson's Disease Cognitive Rating Scale (PD-CRS)
时间窗: 12 weeks
Total score reduction in the PD-CRS at 12 weeks compared to the Baseline. The PD-CRS detects early cognitive impairment in Parkinson's disease. It is composed of 2 scales, the subcortical scale (items 1, 3, 4, 5, 7, 8, 9) and the cortical scale (items 2, 6). The total score of the subcortical scale is from 0 to 114. The total score of the cortical scale is from 0 to 20. The PD-CRS Total score represents the sum of scores on the cortical and subcortical scales. It ranges from 0 to 134. The more points, the less the impairment.
次要结局
- PD-CRS subscale scores(24 weeks)
- PD-CRS total score(24 weeks)
- Dementia Rating Scale - 2 (DRS-2) total score(12 weeks)
- DRS-2 total score(24 weeks)
- DRS-2 subscale scores(24 weeks)
- Clinical Global Impression (CGI) Change in Cognitive Dysfunction (CGI-C Cognition)(6 weeks)
- CGI-C Cognition(12 weeks)
- CGI-Severity in Cognitive Dysfunction (CGI-S Cognition)(6 weeks)
- CGI-S Cognition(12 weeks)
- Patient's Clinical Global Impression of Change in Cognitive (PCGI-C Cognition)(6 weeks)
- PCGI-C Cognition(12 weeks)
- Grid-Hamilton Depression Rating Scale (Grid-HAMD)(6 weeks)
- Grid-HAMD(12 weeks)
- Parkinson's Disease Sleep Scale (PDSS)(6 weeks)
- PDSS(12 weeks)
- Apathy Scale (AS)(6 weeks)
- AS(12 weeks)
研究者
研究点 (15)
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