A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment Phase
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 3
- 主要终点
- Change From Baseline to Week 16 in Total Recall on the Selective Reminding Test (SRT) in the Intent to Treat (ITT) Population
研究概览
简要总结
This study evaluated the efficacy and safety of 10 cm² rivastigmine patch vs. placebo in cognitively impaired Multiple Sclerosis (MS) patients. Primary objective was the assessment of cognition by the Selective Reminding Test (SRT) -a subtest of the brief repeatable battery (BRB) - after titration of 4 weeks and maintenance of 12 weeks. This double-blind period was followed by a 52-week open-label treatment phase to assess long-term safety of rivastigmine patch in these patients.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent to participate in the trial
- •Males and females between 18 and 55 years of age;
- •Definite diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria
- •MS-subtype: Clinical isolated syndrome (CIS), Relapsing Remitting Multiple Sclerosis (RRMS), Secondary progressive Multiple Sclerosis (SPMS);
- •Cognitive Impairment
- •Sufficient education to read, write and communicate comprehensibly
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception
- •With a physical or sensory disability that can subjectively prevent the patient from completing all study requirements
- •Patients suffering any other type of concomitant psychiatric and/or neurological disorder other than MS which is known to affect cognition (e.g. severe depressive symptoms, cerebrovascular diseases, epilepsy).
- •Patients suffering an acute relapse of MS in the previous 30 days (treated or not with intravenous or oral glucocorticoid regimens) prior to baseline.
- •With a history or current problem of drug-addiction and/or alcohol abuse.
- •Known or 'new' diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [≥126 mg/dL or ≥7 mmol/L if fasting and ≥200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)
- •With a history of severe or moderate-severe cranioencephalic trauma.
- •History or presence of any intolerance or contraindication for the application of rivastigmine (or for drugs with similar chemical structures) as listed in the current Investigator's Brochure and/or SPC, i.e. severe liver insufficiency, pancreatitis, gastric ulcer, convulsions.
- •With a history in the past year or a current diagnosis of cerebrovascular disease (for instance, stroke, transient ischemic events, aneurysms).
- •Severe depressive symptoms indicated by a score of more than ≥ 14 on the MADRS at screening
- •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Rivastigmine
Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.
干预措施: Rivastigmine transdermal patch (Drug)
Placebo
Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 16 in Total Recall on the Selective Reminding Test (SRT) in the Intent to Treat (ITT) Population
时间窗: After 16 weeks of treatment
The Selective Reminding Test(SRT) is a test to assess verbal learning and memory. During the administration of the SRT only the examiner and the patient should be in the testing room. A list of twelve words is read aloud by the examiner at a rate of one word per two seconds. The patient is asked to recall all twelve words. Only the words that are missed on the preceding trial are given in the consecutive trial. The total score represents a sum score of 6 trials, therefore the range is from 0-72. The lower the value the worse the outcome.
次要结局
未报告次要终点