EUCTR2008-007015-32-DE进行中（未招募）不适用
A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase
ovartis Pharma GmbH0 个研究点开始时间: 2009年3月3日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Written informed consent to participate in the trial
- •2)Males and females between 18 and 55 years of age;
- •3)Definite diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria (Appendix 4)
- •4)MS-subtype: CIS, RRMS, SPMS;
- •6)Stable and well tolerated therapy with interferon beta-1b (Extavia®) for at least 60 days immediately prior to baseline. This period does not apply to patients swithed directly from Betaferon.
- •7)Cognitive Impairment defined as FST score of =3.0 and/or MUSIC score of =19 at screening
- •8)Verbal memory impairment defined as a score =0.5 standard deviations (SD) below age- and sex-based normative data on the RAVLT score at screening
- •9)Sufficient education to read, write and communicate comprehensibly
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •2.Patient with advanced disease serious enough to, under the judgment of the physician-investigator, place the patient at a special risk situation.
- •owho are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml))
- •owho are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception
- •4.With a physical or sensory disability that can subjectively prevent the patient from completing all study requirements
- •5.Patients without contractual capability.
- •6.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).
- •7.Patients suffering an acute relapse of MS in the previous 30 days (treated or not with intravenous or oral glucocorticoid regimens) prior to baseline.
- •8.Patients on any other treatment for MS than described in inclusion criteria
- •9.With a history or current problem of drug-addiction and/or alcohol abuse.
- •10.Current or historical laboratory evidence of vitamin B1 and/or vitamin B12 deficit
- •11.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)
- •12.Any of the following hepatic conditions:
- •total or conjugated bilirubin greater than 2 times the upper limit of the normal range, unless in context of Gilbert’s syndrome
- •AST (=SGOT), ALT (=SGPT) greater than 3 times the upper limit of the normal range
- •13.With any of the following abnormal laboratory values at screening:
- •serum creatinine >2 ULN or a history of hemodialysis
- •white blood cell (WBC) count <3,500/mm³ (<3.5 x 109 / L)
- •Serum electrolyte, BUN and Thyroidea stimulating hormone (TSH) concentrations outside the range as specified also in Appendix 2.
- •14.With a history of severe or moderate-severe cranioencephalic trauma.
- •15.Study personnel or first degree relatives of investigator(s) must not be included in the study
- •16.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.
- •17.Patients with any of the following diseases serious or unstable: gastrointestinal disease; clinically significant urinary obstruction under clinical judgement; acute, severe or unstable asthmatic conditions [for instance, severe chronic obstructive pulmonary disease (COPD)]; current and known diagnosis of severe or unstable cardiovascular disease; current and known diagnosis of bradycardia (? 40 bpm), sinus syndrome or conductivity disorders (atrial sinus blockage, 2nd or 3rd degree atrioventricular block).
- •18.With a history in the past year or a current diagnosis of cerebrovascular disease (for instance, stroke, transient ischemic events, aneurysms).
- •19.Severe depressive symptoms indicated by a score of more than = 14 on the MADRS at screening
- •20.Patients who have performed a cognitive testing with Brief rep
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